TY - JOUR
AU - Zuber, M
AB - Abstract Background The purpose of this study was to evaluate improvements in cosmetic results and postoperative morbidity for single-incision laparoscopic cholecystectomy (SILC) in comparison with multiport laparoscopic cholecystectomy (MLC). Methods A literature search was undertaken for RCTs comparing SILC with MLC in adult patients with benign gallbladder disease. Primary outcomes were body image and cosmesis scores at different time points. Secondary outcomes included intraoperative and postoperative complications, postoperative pain and frequency of port-site hernia. Results Thirty-seven RCTs were included, with a total of 3051 patients. The body image score favoured SILC at all time points (short term: mean difference (MD) –2·09, P < 0·001; mid term: MD −1·33, P < 0·001), as did the cosmesis score (short term: MD 3·20, P < 0·001; mid term: MD 4·03, P < 0·001; long-term: MD 4·87, P = 0·05) and the wound satisfaction score (short term: MD 1·19, P = 0·03; mid term: MD 1·38, P < 0·001; long-term: MD 1·19, P = 0·02). Duration of operation was longer for SILC (MD 13·56 min; P < 0·001) and SILC required more additional ports (odds ratio (OR) 6·78; P < 0·001). Postoperative pain assessed by a visual analogue scale (VAS) was lower for SILC at 12 h after operation (MD in VAS score −0·80; P = 0·007). The incisional hernia rate was higher after SILC (OR 2·50, P = 0·03). All other outcomes were similar for both groups. Conclusion SILC is associated with better outcomes in terms of cosmesis, body image and postoperative pain. The risk of incisional hernia is four times higher after SILC than after MLC. Introduction Benign gallstone disease is a common finding in developed countries, affecting 10–15 per cent of the adult population1. Approximately 20 per cent of those affected develop symptomatic gallstone disease requiring surgical removal of the gallbladder, making cholecystectomy one of the most common procedures in general surgery. First performed in 19852, laparoscopic three-port cholecystectomy rapidly established itself as the standard for the treatment of symptomatic cholelithiasis. Owing to its efficacy, safety and shorter convalescence, the technique was considered superior to open cholecystectomy even in the absence of evidence derived from randomized trials3,4. In an attempt to improve postoperative morbidity and cosmetic results further, new laparoscopic techniques using fewer incisions were developed, such as three-port and single-port cholecystectomy, as well as natural orifice transluminal endoscopic surgery5–8. Although it has increased gradually in popularity since the first publication in 19977, single-incision laparoscopic cholecystectomy (SILC) is still not in widespread use and its acceptance as a routine practice has remained controversial. This is partly because of the lack of high-quality evidence of improved outcome using this technique9–11. The main reason for performing SILC is improved cosmesis and body image. However, the extent to which this technique contributes to improved outcomes assessed by validated scores in RCTs is still unknown. There are few data in the literature regarding long-term outcome, quality of life (QoL), cost-effectiveness and complication rates assessed by means of validated classification tools. Therefore, this systematic review and meta-analysis was conducted to compare the single-port and conventional multiport laparoscopic cholecystectomy (MLC) techniques in terms of cosmesis and body image, short- as well as long-term postoperative outcomes, and QoL in patients undergoing laparoscopic cholecystectomy for benign gallbladder disease. Methods A systematic review protocol was registered and made available online in the international PROSPERO database (CRD42015019347). This study was reported in compliance with the PRISMA checklist for systematic reviews and meta-analyses12. Eligibility criteria Published and ongoing RCTs were included. Animal studies were excluded. Retrospective studies, quasi-randomized trials, and prospective cohort and case–control studies were excluded as there is inherent selection bias. There was no language restriction. Participants in the included studies were adults undergoing elective or emergency laparoscopic cholecystectomy for any reason (symptomatic gallstones, acute and chronic cholecystitis, including acalculous, or any other benign condition such as polyps). SILC with or without additional ports (intention-to-treat analysis) as well as MLC with two or more ports (typically 4) were included. Primary outcomes Patient satisfaction with cosmesis and body image at different time points after surgery was assessed by means of the validated cosmesis scale (ranging from 3 to 24, with a higher score indicating a greater degree of satisfaction with the scar) and the Body Image Questionnaire (BIQ) (ranging from 5 to 20 points, with a low score signifying better body image)13, or using a linear wound satisfaction score ranging from 1 (worst) to 10 (best). Secondary outcomes Secondary outcomes included intraoperative blood loss, use of additional ports, rate of conversion to open cholecystectomy, duration of operation, postoperative pain, postoperative analgesia use, intraoperative and postoperative complications, length of hospital stay, costs, time to return to work and postoperative QoL. Search methods for identification of studies The bibliographic databases MEDLINE, PubMed, the Cochrane Library, Embase and Scopus were searched for relevant articles from 1 January 1995 to 30 September 2015. The search terms single incision, single port, single site, single scar, single trocar, single access, single incision multiport laparoendoscopic, transumbilical, transumbilical single-port, laparo-endoscopic single-site, minimal invasive, minimal access, single umbilical incision, umbilical port-only, SILS, SILC, LESS, TUSPS and SIMPLE, and medical subject (MeSH) headings cholecystectomy, laparoscopic cholecystectomy, surgery, laparoscopic surgery, gallbladder surgery, laparoscopic gallbladder surgery, gallbladder removal, laparoscopic gallbladder removal, gallbladder resection and laparoscopic gallbladder resection, were used in various combinations. Two authors reviewed relevant articles independently and duplicates were removed. Abstracts, letters, editorials and opinion articles were excluded. Discrepancies were resolved at an official meeting of the investigators. Data extraction and analysis Data collection was carried out by two independent reviewers using a predefined electronic protocol (available at www.review-net.com), including first author's name, publication year, study design, total number of patients, number of patients in the SILC and MLC groups, age (mean, median, s.d., s.e.m., range, i.q.r.), sex ratio and preoperative BMI (weight and height). Data collected on the primary outcome comprised postoperative scores for satisfaction with cosmesis and body image at different time points. The following data were collected for the secondary endpoints: type of operation, surgical technique, duration of surgery (mean, median, s.d., s.e.m., range, i.q.r.), blood loss (mean, median, s.d., s.e.m., range, i.q.r.), rate of conversion to open cholecystectomy, intraoperative and postoperative complications, type of complications, postoperative pain (measured using a visual analogue scale (VAS) ranging from 0 indicating no pain to 10 for worst imaginable pain), postoperative use of analgesics, length of postoperative hospital stay (mean, median, s.d., range, i.q.r.), postoperative QoL, costs, mortality and reason for death. Authors of the individual trials were contacted for missing information. An intention-to-treat analysis was performed whenever possible. When the mean and s.d. were not available, they were calculated from the median and range using an approved calculator. Data synthesis and assessment of heterogeneity Statistical meta-analysis was performed using Review Manager version 5.3 for Mac (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark), and Comprehensive Meta-Analysis version 2 (Biostat, Englewood, New Jersey, USA; http://www.comprehensive.com) was used for single-group analysis. A quantitative synthesis was used because the included studies were sufficiently homogeneous. A narrative synthesis of the findings from the included studies was prepared. Intervention effects for each study and overall effect estimates were calculated as odds ratios (ORs) for dichotomous outcomes and weighted mean differences (MDs) for continuous outcomes, with 95 per cent confidence intervals. Two-sided P values for each outcome were calculated and P < 0·050 was considered significant. The degree of heterogeneity among results was estimated by using the Cochrane Q statistic (with P < 0·100 considered to indicate significant heterogeneity) and the I2 statistic (a value exceeding 50 per cent indicated significant heterogeneity). I2 describes the percentage of total variation across studies that is due to heterogeneity rather than chance. A random-effects model was used for meta-analysis if either of the two statistics was significant; otherwise a fixed-effect model was used. In the fixed-effect model, the only source of uncertainty is within-study error. In the random-effects model, there is this same source of uncertainty plus between-studies variance. Thus the fixed-effect model provides the best estimate of a common treatment effect, whereas the random-effects model provides an estimate of the average treatment effect14. The evidence of publication bias was assessed by inspection of a funnel plot. Results Search results A total of 2098 records were identified through electronic searches of Embase (491), MEDLINE (550), PubMed (2), the Cochrane Library (202) and Scopus (853). In addition, the most recent unpublished RCT, which was not yet available at the time of the searches, was provided by one of the authors15. After excluding duplicates, 1125 records remained. These records were screened for relevance by title and abstract, and 1025 of them were excluded. The remaining 100 full-text articles were assessed for eligibility. Of these, 63 references were excluded. No additional RCTs were identified through screening of the citation lists of relevant publications. In total, 37 studies were included (Fig. 1). Fig. 1 Open in new tabDownload slide Flow diagram showing selection of articles for review. SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy Included studies The 37 trials included a total of 3051 patients, 1529 (50·1 per cent) in the SILC and 1522 (49·9 per cent) in the MLC group. One trial16 had a 1·5 : 1 allocation ratio, with more patients in the SILC group. Another trial17 allocated patients equally to four-port, three-port and single-port laparoscopic cholecystectomy; the four- and three-port groups were analysed as a single group, resulting in a 2 : 1 ratio. A third study18 had a 2 : 1 allocation ratio with fewer patients in the MLC group. The remaining studies allocated in a 1 : 1 ratio. The mean(s.d.) age was 46·8(4·8) years in the SILC group and 48·0(5·7) years in the MLC group; 36 of 37 trials provided this information. The mean(s.d.) proportion of women was 67(3) per cent in the SILC group and 64(3) per cent in the MLC group. In only two trials19,20 were more men than women included in both groups. Two trials18,21 included only women and another four trials22–25 did not provide this information. All except seven studies23,26–31 reported BMI. The mean(s.d.) BMI was 26·6(2·1) kg/m2 in the SILC group and 26·1(2·5) kg/m2 in the MLC group. Twenty-one studies16,17,19,21,23,24,28–30,32–43 excluded obese participants depending on the BMI. Twelve trials17,18,26,29,30,32,34,35,37,44–46 included only patients with an ASA grade of I or II and nine16,19–21,38,39,42,47,48 included only patients with ASA grade I–III. In 16 trials the anaesthetic risk status was not available. Only three trials31,34,49 included emergency laparoscopic cholecystectomies. Eight trials performed conventional cholecystectomy with three ports, 27 with four ports and two with both methods. In the SILC group, 17 trials15,16,18–21,27,36,41,42,44–48,50,51 used the SILS™ Port Access System (Covidien, Mansfield, Massachusetts, USA), six22,24,29,32,38,43 the TriPort™ Access System (Olympus, Center Valley, Pennsylvania, USA), two23,25 the SITRAC® Access Device (Edlo, Porto Alegre, Brazil) and one37 the QuadraPort® Access Device (Lagis, Taichung, Taiwan). One trial31 used both the TriPort™ and SILS™ Port, and nine trials17,26,30,33–35,39,40,49 did not use a particular access device. Information about the access device was not available in one trial28. Follow-up ranged between 1 and 69 weeks. Seven studies26–30,32,51 did not report this information. Further details of included studies can be found in Table 1 and Appendix S1 (supporting information). Table 1 Baseline patient characteristics Reference . Country . No. of patients . Age (years)* . Sex ratio (F : M) . BMI (kg/m2)* . Follow-up (weeks) . SILC . MLC . SILC . MLC . SILC . MLC . SILC . MLC . Abd Ellatif et al.35 Egypt 125 125 47·7(10·6) 46·9(11·4) 95 : 30 88 : 37 26·9(5·5) 29·5(5·6) 26 Aprea et al.32 Italy 25 25 45·5(9·4) 44(10) 16 : 14‡ 19 : 6 25·9(5·8) 23·7(4·6) n.r. Borle et al.50 India 30 30 42·3(11·8) 40·2(14·4) 20 : 10 23 : 7 23(1·8) 23·4(1·8) 4 Bresadola et al.26 Italy 28 37 42(20) 45(15) 19 : 9 22 : 15 n.r. n.r. n.r. Brown et al.33 USA 40 39 45·1(14·5) 43(14·8) 29 : 11 32 : 7 29·4(5·1) 30·3(6·9) 4 Bucher et al.22 Switzerland 75 75 45·8(16·4) 44(9·7) n.r. n.r. 27·3(3·4) 25·8(3·9) 4 Cao et al.34 China 57 51 62·2(5·1) 59·7(4·4) 34 : 23 29 : 22 28·6(4·4) 29·1(5·1) 4 Chang et al.44 Singapore 51 50 48·2(12·5) 52·5(13·1) 31 : 20 30 : 20 25·3(4·5) 25·8(6·5) 26 Deveci et al.47 Turkey 50 50 42·9(12) 40·1(12·2) 45 : 5 43 : 7 27·9(5) 28·1(5·2) 52 Herrero Fonollosa et al.36 Spain 26 24 45(12) 49(12) 20 : 6 14 : 10 26(4) 25(2) 26 Jørgensen et al.21 Denmark 60 60 45·5 (34·3–54·0)† 46 (33·0–56·0)† 60 : 0 60 : 0 26·6 (23·9–28·4)† 24 (22·8–29·1)† 52 Justo-Janeiro et al.45 Mexico 18 19 42·8(15·8) 44·1(17·5) 16 : 2 13 : 6 28·2(3·1) 27·6(4·7) 1 Khorgami et al.17 Iran 30 60 43·8(12·7) 41·6(11·1) 22 : 8 41 : 19 27·9(4·3) 27·7(4·2) 52 Lai et al.48 Hong Kong 24 27 51·7(13·3) 54·3(12) 16 : 8 16 : 11 25(3) 24·4(2·8) 12 Lee et al.37 Taiwan 35 35 51(13·5) 53·3(15·5) 22 : 13 20 : 15 24·2(3·4) 25·8(3) 26 Lirici et al.38 Italy 20 20 44·8(9·3) 47·8(10·8) 14 : 6 14 : 6 24·2(3·2) 25·4(3·5) 4 Luna et al.23 Brazil 20 20 n.r. n.r. n.r. n.r. n.r. n.r. 4 Lurje et al.15 Switzerland 48 48 48(16) 44(1) 33 : 15 29 : 19 25(3) 26(5) 52 Ma et al.24 USA 21 22 57·3(16) 45·8(11·9) n.r. n.r. 28·2(5·3) 30·7(6·1) 33 Madureira et al.25 Brazil 28 29 50(9·8) 56(17) n.r. n.r. 28·6(7·7) 25·5(4·4) 26 Marks et al.16 USA 119 81 45·8(9·8) 44(8·7) 91 : 28 57 : 24 29·5(7·7) 31·5(6·7) 52 Mehmood et al.27 Pakistan 30 30 44·4(8·6) 42·7(9·1) 28 : 2 26 : 4 n.r. n.r. n.r. Noguera et al.46 Spain 20 20 49(4) 60(5) 17 : 3 16 : 4 28(4) 30(1) 52 Pan et al.39 China 49 53 43·8(14) 45·2(1) 26 : 23 31 : 22 24·3(6) 25·1(5) 8 Rašić et al.40 Croatia 48 50 44(6) 44(5·7) 26 : 22 32 : 18 27(4) 27(4) 4 Rizwi et al.28 Pakistan 100 100 40·8(7·9) 42·5(8·7) 59 : 41 57 : 43 n.r. n.r. n.r. Saad et al.19 Germany 35 35 45(17) 49(14) 7 : 28 9 : 26 25·4(2·5) 25·4(3·1) 52 Sasaki et al.20 Japan 27 27 56·6(14·2) 58·2(12·3) 13 : 14 13 : 14 24·4(3) 24·9(3·4) 4 Sinan et al.41 Turkey 17 17 48·5(8·9) 48·7(14·3) 13 : 4 9 : 8 27·3(3·1) 27·2(2·9) 39 Solomon et al.18 USA 22 11 38·4(3·3) 35·5(4·1) 22 : 0 11 : 0 31·8(1·4) 31·4(2·2) 4 Telciler et al.51 Turkey 20 20 47·1(10) 49·5(14·2) 15 : 5 14 : 6 26·1(3·9) 27·8(3·6) n.r. Tsimogiannis et al.29 Greece 20 20 42·2(7·3) 48·5(12·8) 15 : 5 13 : 7 n.r. n.r. n.r. Tsimoyiannis et al.30 Greece 20 20 49·2(16·9) 47·9(9·8) 15 : 5 19 : 1 n.r. n.r. n.r. Vilallonga et al.31 Spain, Turkey 69 71 43·2(14·6) 42·6(14·6) 38 : 31 36 : 35 n.r. n.r. 30 Yilmaz et al.42 Turkey 43 40 48·5(12) 51(9) 34 : 9 27 : 13 24·2(4) 23·3(3) 1 Zapf et al.49 USA 49 51 44·2(16·2) 50·9(18·2) 42 : 7 34 : 17 29·1(6·5) 30(6·3) 69 Zheng et al.43 China 30 30 43·6(11·3) 46·8(14·4) 17 : 13 14 : 16 24·7(3·4) 25·9(4·1) 48 Reference . Country . No. of patients . Age (years)* . Sex ratio (F : M) . BMI (kg/m2)* . Follow-up (weeks) . SILC . MLC . SILC . MLC . SILC . MLC . SILC . MLC . Abd Ellatif et al.35 Egypt 125 125 47·7(10·6) 46·9(11·4) 95 : 30 88 : 37 26·9(5·5) 29·5(5·6) 26 Aprea et al.32 Italy 25 25 45·5(9·4) 44(10) 16 : 14‡ 19 : 6 25·9(5·8) 23·7(4·6) n.r. Borle et al.50 India 30 30 42·3(11·8) 40·2(14·4) 20 : 10 23 : 7 23(1·8) 23·4(1·8) 4 Bresadola et al.26 Italy 28 37 42(20) 45(15) 19 : 9 22 : 15 n.r. n.r. n.r. Brown et al.33 USA 40 39 45·1(14·5) 43(14·8) 29 : 11 32 : 7 29·4(5·1) 30·3(6·9) 4 Bucher et al.22 Switzerland 75 75 45·8(16·4) 44(9·7) n.r. n.r. 27·3(3·4) 25·8(3·9) 4 Cao et al.34 China 57 51 62·2(5·1) 59·7(4·4) 34 : 23 29 : 22 28·6(4·4) 29·1(5·1) 4 Chang et al.44 Singapore 51 50 48·2(12·5) 52·5(13·1) 31 : 20 30 : 20 25·3(4·5) 25·8(6·5) 26 Deveci et al.47 Turkey 50 50 42·9(12) 40·1(12·2) 45 : 5 43 : 7 27·9(5) 28·1(5·2) 52 Herrero Fonollosa et al.36 Spain 26 24 45(12) 49(12) 20 : 6 14 : 10 26(4) 25(2) 26 Jørgensen et al.21 Denmark 60 60 45·5 (34·3–54·0)† 46 (33·0–56·0)† 60 : 0 60 : 0 26·6 (23·9–28·4)† 24 (22·8–29·1)† 52 Justo-Janeiro et al.45 Mexico 18 19 42·8(15·8) 44·1(17·5) 16 : 2 13 : 6 28·2(3·1) 27·6(4·7) 1 Khorgami et al.17 Iran 30 60 43·8(12·7) 41·6(11·1) 22 : 8 41 : 19 27·9(4·3) 27·7(4·2) 52 Lai et al.48 Hong Kong 24 27 51·7(13·3) 54·3(12) 16 : 8 16 : 11 25(3) 24·4(2·8) 12 Lee et al.37 Taiwan 35 35 51(13·5) 53·3(15·5) 22 : 13 20 : 15 24·2(3·4) 25·8(3) 26 Lirici et al.38 Italy 20 20 44·8(9·3) 47·8(10·8) 14 : 6 14 : 6 24·2(3·2) 25·4(3·5) 4 Luna et al.23 Brazil 20 20 n.r. n.r. n.r. n.r. n.r. n.r. 4 Lurje et al.15 Switzerland 48 48 48(16) 44(1) 33 : 15 29 : 19 25(3) 26(5) 52 Ma et al.24 USA 21 22 57·3(16) 45·8(11·9) n.r. n.r. 28·2(5·3) 30·7(6·1) 33 Madureira et al.25 Brazil 28 29 50(9·8) 56(17) n.r. n.r. 28·6(7·7) 25·5(4·4) 26 Marks et al.16 USA 119 81 45·8(9·8) 44(8·7) 91 : 28 57 : 24 29·5(7·7) 31·5(6·7) 52 Mehmood et al.27 Pakistan 30 30 44·4(8·6) 42·7(9·1) 28 : 2 26 : 4 n.r. n.r. n.r. Noguera et al.46 Spain 20 20 49(4) 60(5) 17 : 3 16 : 4 28(4) 30(1) 52 Pan et al.39 China 49 53 43·8(14) 45·2(1) 26 : 23 31 : 22 24·3(6) 25·1(5) 8 Rašić et al.40 Croatia 48 50 44(6) 44(5·7) 26 : 22 32 : 18 27(4) 27(4) 4 Rizwi et al.28 Pakistan 100 100 40·8(7·9) 42·5(8·7) 59 : 41 57 : 43 n.r. n.r. n.r. Saad et al.19 Germany 35 35 45(17) 49(14) 7 : 28 9 : 26 25·4(2·5) 25·4(3·1) 52 Sasaki et al.20 Japan 27 27 56·6(14·2) 58·2(12·3) 13 : 14 13 : 14 24·4(3) 24·9(3·4) 4 Sinan et al.41 Turkey 17 17 48·5(8·9) 48·7(14·3) 13 : 4 9 : 8 27·3(3·1) 27·2(2·9) 39 Solomon et al.18 USA 22 11 38·4(3·3) 35·5(4·1) 22 : 0 11 : 0 31·8(1·4) 31·4(2·2) 4 Telciler et al.51 Turkey 20 20 47·1(10) 49·5(14·2) 15 : 5 14 : 6 26·1(3·9) 27·8(3·6) n.r. Tsimogiannis et al.29 Greece 20 20 42·2(7·3) 48·5(12·8) 15 : 5 13 : 7 n.r. n.r. n.r. Tsimoyiannis et al.30 Greece 20 20 49·2(16·9) 47·9(9·8) 15 : 5 19 : 1 n.r. n.r. n.r. Vilallonga et al.31 Spain, Turkey 69 71 43·2(14·6) 42·6(14·6) 38 : 31 36 : 35 n.r. n.r. 30 Yilmaz et al.42 Turkey 43 40 48·5(12) 51(9) 34 : 9 27 : 13 24·2(4) 23·3(3) 1 Zapf et al.49 USA 49 51 44·2(16·2) 50·9(18·2) 42 : 7 34 : 17 29·1(6·5) 30(6·3) 69 Zheng et al.43 China 30 30 43·6(11·3) 46·8(14·4) 17 : 13 14 : 16 24·7(3·4) 25·9(4·1) 48 * Values are mean(s.d.), except † median (i.q.r.). ‡ Numbers as reported by Aprea et al.32. SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy; n.r., not reported. Open in new tab Table 1 Baseline patient characteristics Reference . Country . No. of patients . Age (years)* . Sex ratio (F : M) . BMI (kg/m2)* . Follow-up (weeks) . SILC . MLC . SILC . MLC . SILC . MLC . SILC . MLC . Abd Ellatif et al.35 Egypt 125 125 47·7(10·6) 46·9(11·4) 95 : 30 88 : 37 26·9(5·5) 29·5(5·6) 26 Aprea et al.32 Italy 25 25 45·5(9·4) 44(10) 16 : 14‡ 19 : 6 25·9(5·8) 23·7(4·6) n.r. Borle et al.50 India 30 30 42·3(11·8) 40·2(14·4) 20 : 10 23 : 7 23(1·8) 23·4(1·8) 4 Bresadola et al.26 Italy 28 37 42(20) 45(15) 19 : 9 22 : 15 n.r. n.r. n.r. Brown et al.33 USA 40 39 45·1(14·5) 43(14·8) 29 : 11 32 : 7 29·4(5·1) 30·3(6·9) 4 Bucher et al.22 Switzerland 75 75 45·8(16·4) 44(9·7) n.r. n.r. 27·3(3·4) 25·8(3·9) 4 Cao et al.34 China 57 51 62·2(5·1) 59·7(4·4) 34 : 23 29 : 22 28·6(4·4) 29·1(5·1) 4 Chang et al.44 Singapore 51 50 48·2(12·5) 52·5(13·1) 31 : 20 30 : 20 25·3(4·5) 25·8(6·5) 26 Deveci et al.47 Turkey 50 50 42·9(12) 40·1(12·2) 45 : 5 43 : 7 27·9(5) 28·1(5·2) 52 Herrero Fonollosa et al.36 Spain 26 24 45(12) 49(12) 20 : 6 14 : 10 26(4) 25(2) 26 Jørgensen et al.21 Denmark 60 60 45·5 (34·3–54·0)† 46 (33·0–56·0)† 60 : 0 60 : 0 26·6 (23·9–28·4)† 24 (22·8–29·1)† 52 Justo-Janeiro et al.45 Mexico 18 19 42·8(15·8) 44·1(17·5) 16 : 2 13 : 6 28·2(3·1) 27·6(4·7) 1 Khorgami et al.17 Iran 30 60 43·8(12·7) 41·6(11·1) 22 : 8 41 : 19 27·9(4·3) 27·7(4·2) 52 Lai et al.48 Hong Kong 24 27 51·7(13·3) 54·3(12) 16 : 8 16 : 11 25(3) 24·4(2·8) 12 Lee et al.37 Taiwan 35 35 51(13·5) 53·3(15·5) 22 : 13 20 : 15 24·2(3·4) 25·8(3) 26 Lirici et al.38 Italy 20 20 44·8(9·3) 47·8(10·8) 14 : 6 14 : 6 24·2(3·2) 25·4(3·5) 4 Luna et al.23 Brazil 20 20 n.r. n.r. n.r. n.r. n.r. n.r. 4 Lurje et al.15 Switzerland 48 48 48(16) 44(1) 33 : 15 29 : 19 25(3) 26(5) 52 Ma et al.24 USA 21 22 57·3(16) 45·8(11·9) n.r. n.r. 28·2(5·3) 30·7(6·1) 33 Madureira et al.25 Brazil 28 29 50(9·8) 56(17) n.r. n.r. 28·6(7·7) 25·5(4·4) 26 Marks et al.16 USA 119 81 45·8(9·8) 44(8·7) 91 : 28 57 : 24 29·5(7·7) 31·5(6·7) 52 Mehmood et al.27 Pakistan 30 30 44·4(8·6) 42·7(9·1) 28 : 2 26 : 4 n.r. n.r. n.r. Noguera et al.46 Spain 20 20 49(4) 60(5) 17 : 3 16 : 4 28(4) 30(1) 52 Pan et al.39 China 49 53 43·8(14) 45·2(1) 26 : 23 31 : 22 24·3(6) 25·1(5) 8 Rašić et al.40 Croatia 48 50 44(6) 44(5·7) 26 : 22 32 : 18 27(4) 27(4) 4 Rizwi et al.28 Pakistan 100 100 40·8(7·9) 42·5(8·7) 59 : 41 57 : 43 n.r. n.r. n.r. Saad et al.19 Germany 35 35 45(17) 49(14) 7 : 28 9 : 26 25·4(2·5) 25·4(3·1) 52 Sasaki et al.20 Japan 27 27 56·6(14·2) 58·2(12·3) 13 : 14 13 : 14 24·4(3) 24·9(3·4) 4 Sinan et al.41 Turkey 17 17 48·5(8·9) 48·7(14·3) 13 : 4 9 : 8 27·3(3·1) 27·2(2·9) 39 Solomon et al.18 USA 22 11 38·4(3·3) 35·5(4·1) 22 : 0 11 : 0 31·8(1·4) 31·4(2·2) 4 Telciler et al.51 Turkey 20 20 47·1(10) 49·5(14·2) 15 : 5 14 : 6 26·1(3·9) 27·8(3·6) n.r. Tsimogiannis et al.29 Greece 20 20 42·2(7·3) 48·5(12·8) 15 : 5 13 : 7 n.r. n.r. n.r. Tsimoyiannis et al.30 Greece 20 20 49·2(16·9) 47·9(9·8) 15 : 5 19 : 1 n.r. n.r. n.r. Vilallonga et al.31 Spain, Turkey 69 71 43·2(14·6) 42·6(14·6) 38 : 31 36 : 35 n.r. n.r. 30 Yilmaz et al.42 Turkey 43 40 48·5(12) 51(9) 34 : 9 27 : 13 24·2(4) 23·3(3) 1 Zapf et al.49 USA 49 51 44·2(16·2) 50·9(18·2) 42 : 7 34 : 17 29·1(6·5) 30(6·3) 69 Zheng et al.43 China 30 30 43·6(11·3) 46·8(14·4) 17 : 13 14 : 16 24·7(3·4) 25·9(4·1) 48 Reference . Country . No. of patients . Age (years)* . Sex ratio (F : M) . BMI (kg/m2)* . Follow-up (weeks) . SILC . MLC . SILC . MLC . SILC . MLC . SILC . MLC . Abd Ellatif et al.35 Egypt 125 125 47·7(10·6) 46·9(11·4) 95 : 30 88 : 37 26·9(5·5) 29·5(5·6) 26 Aprea et al.32 Italy 25 25 45·5(9·4) 44(10) 16 : 14‡ 19 : 6 25·9(5·8) 23·7(4·6) n.r. Borle et al.50 India 30 30 42·3(11·8) 40·2(14·4) 20 : 10 23 : 7 23(1·8) 23·4(1·8) 4 Bresadola et al.26 Italy 28 37 42(20) 45(15) 19 : 9 22 : 15 n.r. n.r. n.r. Brown et al.33 USA 40 39 45·1(14·5) 43(14·8) 29 : 11 32 : 7 29·4(5·1) 30·3(6·9) 4 Bucher et al.22 Switzerland 75 75 45·8(16·4) 44(9·7) n.r. n.r. 27·3(3·4) 25·8(3·9) 4 Cao et al.34 China 57 51 62·2(5·1) 59·7(4·4) 34 : 23 29 : 22 28·6(4·4) 29·1(5·1) 4 Chang et al.44 Singapore 51 50 48·2(12·5) 52·5(13·1) 31 : 20 30 : 20 25·3(4·5) 25·8(6·5) 26 Deveci et al.47 Turkey 50 50 42·9(12) 40·1(12·2) 45 : 5 43 : 7 27·9(5) 28·1(5·2) 52 Herrero Fonollosa et al.36 Spain 26 24 45(12) 49(12) 20 : 6 14 : 10 26(4) 25(2) 26 Jørgensen et al.21 Denmark 60 60 45·5 (34·3–54·0)† 46 (33·0–56·0)† 60 : 0 60 : 0 26·6 (23·9–28·4)† 24 (22·8–29·1)† 52 Justo-Janeiro et al.45 Mexico 18 19 42·8(15·8) 44·1(17·5) 16 : 2 13 : 6 28·2(3·1) 27·6(4·7) 1 Khorgami et al.17 Iran 30 60 43·8(12·7) 41·6(11·1) 22 : 8 41 : 19 27·9(4·3) 27·7(4·2) 52 Lai et al.48 Hong Kong 24 27 51·7(13·3) 54·3(12) 16 : 8 16 : 11 25(3) 24·4(2·8) 12 Lee et al.37 Taiwan 35 35 51(13·5) 53·3(15·5) 22 : 13 20 : 15 24·2(3·4) 25·8(3) 26 Lirici et al.38 Italy 20 20 44·8(9·3) 47·8(10·8) 14 : 6 14 : 6 24·2(3·2) 25·4(3·5) 4 Luna et al.23 Brazil 20 20 n.r. n.r. n.r. n.r. n.r. n.r. 4 Lurje et al.15 Switzerland 48 48 48(16) 44(1) 33 : 15 29 : 19 25(3) 26(5) 52 Ma et al.24 USA 21 22 57·3(16) 45·8(11·9) n.r. n.r. 28·2(5·3) 30·7(6·1) 33 Madureira et al.25 Brazil 28 29 50(9·8) 56(17) n.r. n.r. 28·6(7·7) 25·5(4·4) 26 Marks et al.16 USA 119 81 45·8(9·8) 44(8·7) 91 : 28 57 : 24 29·5(7·7) 31·5(6·7) 52 Mehmood et al.27 Pakistan 30 30 44·4(8·6) 42·7(9·1) 28 : 2 26 : 4 n.r. n.r. n.r. Noguera et al.46 Spain 20 20 49(4) 60(5) 17 : 3 16 : 4 28(4) 30(1) 52 Pan et al.39 China 49 53 43·8(14) 45·2(1) 26 : 23 31 : 22 24·3(6) 25·1(5) 8 Rašić et al.40 Croatia 48 50 44(6) 44(5·7) 26 : 22 32 : 18 27(4) 27(4) 4 Rizwi et al.28 Pakistan 100 100 40·8(7·9) 42·5(8·7) 59 : 41 57 : 43 n.r. n.r. n.r. Saad et al.19 Germany 35 35 45(17) 49(14) 7 : 28 9 : 26 25·4(2·5) 25·4(3·1) 52 Sasaki et al.20 Japan 27 27 56·6(14·2) 58·2(12·3) 13 : 14 13 : 14 24·4(3) 24·9(3·4) 4 Sinan et al.41 Turkey 17 17 48·5(8·9) 48·7(14·3) 13 : 4 9 : 8 27·3(3·1) 27·2(2·9) 39 Solomon et al.18 USA 22 11 38·4(3·3) 35·5(4·1) 22 : 0 11 : 0 31·8(1·4) 31·4(2·2) 4 Telciler et al.51 Turkey 20 20 47·1(10) 49·5(14·2) 15 : 5 14 : 6 26·1(3·9) 27·8(3·6) n.r. Tsimogiannis et al.29 Greece 20 20 42·2(7·3) 48·5(12·8) 15 : 5 13 : 7 n.r. n.r. n.r. Tsimoyiannis et al.30 Greece 20 20 49·2(16·9) 47·9(9·8) 15 : 5 19 : 1 n.r. n.r. n.r. Vilallonga et al.31 Spain, Turkey 69 71 43·2(14·6) 42·6(14·6) 38 : 31 36 : 35 n.r. n.r. 30 Yilmaz et al.42 Turkey 43 40 48·5(12) 51(9) 34 : 9 27 : 13 24·2(4) 23·3(3) 1 Zapf et al.49 USA 49 51 44·2(16·2) 50·9(18·2) 42 : 7 34 : 17 29·1(6·5) 30(6·3) 69 Zheng et al.43 China 30 30 43·6(11·3) 46·8(14·4) 17 : 13 14 : 16 24·7(3·4) 25·9(4·1) 48 * Values are mean(s.d.), except † median (i.q.r.). ‡ Numbers as reported by Aprea et al.32. SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy; n.r., not reported. Open in new tab Excluded studies Sixty-three studies were excluded after assessment of the full-text articles (Appendix S1, supporting information). Only abstracts were available for 41 studies. Six were not randomized trials or the control group was not MLC or SILC. In five trials the study population was the same as that in one of the included studies. Three articles were duplicate publications and in another three trials the participants were children. Two comments were excluded, and also two interim reports of included studies and one study protocol. Risk of bias in included studies The risk-of-bias assessment is described in detail in Appendix S2 and summarized in Fig. S1 (supporting information). Only three trials15,19,21 had an overall low risk of bias. Primary outcomes Body image and cosmesis The BIQ score measures the patient's perception of their body as well as their attitude towards their appearance13. Three trials15,22,50 used this score. The values were recorded at different time points. Because of the small sample sizes, the data were pooled in short-term (1–14 days), mid-term (1–3 months) and long-term (6–12 months) groups. On pooling the data, statistically significant differences were found in favour of SILC in the short- and mid-term groups. There was significant heterogeneity in the short-term (I2 = 90 per cent, P < 0·001) and mid-term (I2 = 95 per cent, P < 0·001) groups. In the random-effects model, the mean BIQ score was lower for patients who had SILC, indicating a better perception of their body in the short term (MD −2·09, 95 per cent c.i. –2·64 to −1·55; P < 0·001) (Fig. 2). Similarly, in the random-effects model, the mean BIQ score was lower in the mid term for patients who underwent SILC (MD −1·33, −1·92 to −0·75; P < 0·001) (Fig. 3). Only one study15 reported the BIQ score after 1 year. At this time, the score was superior in the SILC group compared with the MLC group (5 versus 6; P = 0·017). Fig. 2 Open in new tabDownload slide Forest plot comparing short-term Body Image Questionnaire (BIQ) scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Fig. 3 Open in new tabDownload slide Forest plot comparing mid-term Body Image Questionnaire (BIQ) scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Cosmesis score is the degree of patient satisfaction with respect to appearance of scar(s)13. Three trials15,16,50 used this score. The values were recorded at different time points. Again, the data were pooled in short-term (1–14 days), mid-term (1–3 months) and long-term (6–12 months) groups. On pooling the data, statistically significant differences were found in favour of SILC in all intervals. There was significant heterogeneity in the short-term (I2 = 90 per cent, P < 0·001), mid-term (I2 = 94 per cent, P < 0·001) and long-term (I2 = 99 per cent, P < 0·001) groups. In the random-effects model, in the short term (MD 3·20, 1·55 to 4·85; P < 0·001) (Fig. 4), mid term (MD 4·03, 2·70 to 5·37; P < 0·001) (Fig. 5) and long term (MD 4·87, 0·07 to 9·66; P = 0·05) (Fig. 6), the mean cosmesis score was higher among patients who had SILC, indicating better satisfaction with the scar(s). Fig. 4 Open in new tabDownload slide Forest plot comparing short-term cosmesis scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Fig. 5 Open in new tabDownload slide Forest plot comparing mid-term cosmesis scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Fig. 6 Open in new tabDownload slide Forest plot comparing long-term cosmesis scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Wound satisfaction score In 12 trials17,19–21,31,32,35,37–39,47,48 satisfaction with the wound was assessed on a scale from 1 to 10, analogous to the well known VAS used for pain assessment. The values were recorded at different time points. The data were pooled in short-term (1–14 days), mid-term (1–3 months) and long-term (6–12 months) groups. On pooling the data, statistically significant differences were found in favour of SILC in all three intervals. There was significant heterogeneity in the short-term (I2 = 95 per cent, P < 0·001), mid-term (I2 = 98 per cent, P < 0·001) and long-term (I2 = 98 per cent, P < 0·001) groups. In the random-effects model, in the short term (MD 1·19, 95 per cent c.i. 0·13 to 2·24; P = 0·03) (Fig. 7), mid term (MD 1·38, 0·63 to 2·14; P < 0·001) (Fig. 8) and long term (MD 1·19, 0·18 to 2·20; P = 0·02) (Fig. 9), the mean wound satisfaction score was higher in patients who underwent SILC, indicating greater satisfaction with the wound(s). Fig. 7 Open in new tabDownload slide Forest plot comparing short-term wound satisfaction scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Fig. 8 Open in new tabDownload slide Forest plot comparing mid-term wound satisfaction scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Fig. 9 Open in new tabDownload slide Forest plot comparing long-term wound satisfaction scores after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Secondary outcomes An overview of the secondary outcomes is provided in Table 2. Table 2 Overview of secondary outcomes . No. of studies . No. of events or *mean . Odds ratio or †mean difference . P . I2 (%) . . SILC . MLC . Intraoperative blood loss (ml) 13 15·88* 17·33* −0·08 (−1·83, 1·68)† 0·93 62 Duration of operation (min) 29 67·11* 51·91* 13·56 (10·02, 17·09)† < 0·001 91 Use of additional ports 27 90 6 6·78 (4·08, 11·26) < 0·001 0 Conversion to open surgery 6 7 10 0·71 (0·29, 1·78) 0·47 0 Length of hospital stay (days) 24 1·79* 1·86* −0·05 (−0·14, 0·04)† 0·32 86 Time to return to work (days) 9 8·36* 8·87* −0·72 (−1·60, 0·15)† 0·10 86 Gallbladder perforation 7 33 28 1·33 (0·78, 2·28) 0·29 0 Retained bile duct stones 5 6 2 2·03 (0·57, 7·27) 0·28 0 Bile leakage 6 5 3 1·25 (0·41, 3·80) 0·69 0 Intraoperative bleeding 7 8 11 0·84 (0·36, 1·94) 0·68 0 Haematoma 4 7 7 1·02 (0·37, 2·86) 0·97 0 Seroma 5 7 8 0·86 (0·32, 2·28) 0·76 0 Pneumothorax 3 3 0 3·10 (0·48, 20·13) 0·24 0 Port-site hernia 10 19 5 2·50 (1·10, 5·69) 0·03 0 . No. of studies . No. of events or *mean . Odds ratio or †mean difference . P . I2 (%) . . SILC . MLC . Intraoperative blood loss (ml) 13 15·88* 17·33* −0·08 (−1·83, 1·68)† 0·93 62 Duration of operation (min) 29 67·11* 51·91* 13·56 (10·02, 17·09)† < 0·001 91 Use of additional ports 27 90 6 6·78 (4·08, 11·26) < 0·001 0 Conversion to open surgery 6 7 10 0·71 (0·29, 1·78) 0·47 0 Length of hospital stay (days) 24 1·79* 1·86* −0·05 (−0·14, 0·04)† 0·32 86 Time to return to work (days) 9 8·36* 8·87* −0·72 (−1·60, 0·15)† 0·10 86 Gallbladder perforation 7 33 28 1·33 (0·78, 2·28) 0·29 0 Retained bile duct stones 5 6 2 2·03 (0·57, 7·27) 0·28 0 Bile leakage 6 5 3 1·25 (0·41, 3·80) 0·69 0 Intraoperative bleeding 7 8 11 0·84 (0·36, 1·94) 0·68 0 Haematoma 4 7 7 1·02 (0·37, 2·86) 0·97 0 Seroma 5 7 8 0·86 (0·32, 2·28) 0·76 0 Pneumothorax 3 3 0 3·10 (0·48, 20·13) 0·24 0 Port-site hernia 10 19 5 2·50 (1·10, 5·69) 0·03 0 Values in parentheses are 95 per cent confidence intervals. SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy. Open in new tab Table 2 Overview of secondary outcomes . No. of studies . No. of events or *mean . Odds ratio or †mean difference . P . I2 (%) . . SILC . MLC . Intraoperative blood loss (ml) 13 15·88* 17·33* −0·08 (−1·83, 1·68)† 0·93 62 Duration of operation (min) 29 67·11* 51·91* 13·56 (10·02, 17·09)† < 0·001 91 Use of additional ports 27 90 6 6·78 (4·08, 11·26) < 0·001 0 Conversion to open surgery 6 7 10 0·71 (0·29, 1·78) 0·47 0 Length of hospital stay (days) 24 1·79* 1·86* −0·05 (−0·14, 0·04)† 0·32 86 Time to return to work (days) 9 8·36* 8·87* −0·72 (−1·60, 0·15)† 0·10 86 Gallbladder perforation 7 33 28 1·33 (0·78, 2·28) 0·29 0 Retained bile duct stones 5 6 2 2·03 (0·57, 7·27) 0·28 0 Bile leakage 6 5 3 1·25 (0·41, 3·80) 0·69 0 Intraoperative bleeding 7 8 11 0·84 (0·36, 1·94) 0·68 0 Haematoma 4 7 7 1·02 (0·37, 2·86) 0·97 0 Seroma 5 7 8 0·86 (0·32, 2·28) 0·76 0 Pneumothorax 3 3 0 3·10 (0·48, 20·13) 0·24 0 Port-site hernia 10 19 5 2·50 (1·10, 5·69) 0·03 0 . No. of studies . No. of events or *mean . Odds ratio or †mean difference . P . I2 (%) . . SILC . MLC . Intraoperative blood loss (ml) 13 15·88* 17·33* −0·08 (−1·83, 1·68)† 0·93 62 Duration of operation (min) 29 67·11* 51·91* 13·56 (10·02, 17·09)† < 0·001 91 Use of additional ports 27 90 6 6·78 (4·08, 11·26) < 0·001 0 Conversion to open surgery 6 7 10 0·71 (0·29, 1·78) 0·47 0 Length of hospital stay (days) 24 1·79* 1·86* −0·05 (−0·14, 0·04)† 0·32 86 Time to return to work (days) 9 8·36* 8·87* −0·72 (−1·60, 0·15)† 0·10 86 Gallbladder perforation 7 33 28 1·33 (0·78, 2·28) 0·29 0 Retained bile duct stones 5 6 2 2·03 (0·57, 7·27) 0·28 0 Bile leakage 6 5 3 1·25 (0·41, 3·80) 0·69 0 Intraoperative bleeding 7 8 11 0·84 (0·36, 1·94) 0·68 0 Haematoma 4 7 7 1·02 (0·37, 2·86) 0·97 0 Seroma 5 7 8 0·86 (0·32, 2·28) 0·76 0 Pneumothorax 3 3 0 3·10 (0·48, 20·13) 0·24 0 Port-site hernia 10 19 5 2·50 (1·10, 5·69) 0·03 0 Values in parentheses are 95 per cent confidence intervals. SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy. Open in new tab Intraoperative outcomes Thirteen trials reported intraoperative blood loss. There was significant heterogeneity among the trials (I2 = 62 per cent, P = 0·002). In the random-effects model, mean intraoperative blood loss was similar for both groups (MD −0·08 (95 per cent c.i. –1·83 to 1·68) ml; P = 0·93) (Fig. S2, supporting information). Twenty-nine trials reported the duration of operation. There was significant heterogeneity among the trials (I2 = 91 per cent, P < 0·001). In the random-effects model, the mean time taken to perform SILC was 13·56 min longer than that for MLC (MD 13·56 (95 per cent c.i. 10·02 to 17·09) min; P < 0·001) (Fig. 10). Fig. 10 Open in new tabDownload slide Forest plot comparing duration of surgery for single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. *Values are mean(s.d.). A random-effects inverse-variance model was used for meta-analysis. Mean differences are shown with 95 per cent confidence intervals Thirty-one trials reported whether an additional trocar was necessary to complete surgery. In four trials an additional trocar was not necessary in either group. A total of six additional trocars were used in the MLC groups, four in operations starting as three-port and two in procedures starting as four-port laparoscopic cholecystectomy. Ninety additional trocars were used to complete cholecystectomy in the SILC groups. There was no heterogeneity among the 27 trials included in the meta-analysis (I2 = 0 per cent, P = 0·92). In the fixed-effect model, additional ports were more often required to perform SILC than MLC (OR 6·78, 95 per cent c.i. 4·08 to 11·26; P < 0·001) (Fig. S3, supporting information). Thirty-three trials reported the rate of conversion to open surgery. Seven laparoscopic cholecystectomies were converted in the SILC group and ten in the MLC group. There was no heterogeneity among the six trials included in the meta-analysis (I2 = 0 per cent, P = 0·94). In the fixed-effect model, the conversion rate was similar for both groups (OR 0·71, 95 per cent c.i. 0·29 to 1·78; P = 0·47) (Fig. S4, supporting information). Postoperative outcomes Only seven16,24,29,40,46,49,50 trials did not report postoperative pain at least at one time point. Pain scores measured on a VAS were obtained at ten time points (3, 4, 8, 12, 24, 48 and 72 h, 7 and 14 days, and 1 month). There was significant heterogeneity at all time points (I2 = 62–95 per cent). There was a slight trend towards less postoperative pain for SILC at most time points, but this was only significant after 12 h (Table 3; Figs S5–S14, supporting information). In the random-effects model, the mean postoperative pain score after 12 h was higher in the MLC group (MD −0·80, 95 per cent c.i. –1·39 to −0·22; P = 0·007), whereas after 7 days there was a slight trend towards less postoperative pain among patients who had MLC (MD 0·11, −0·54 to 0·77; P = 0·74). Table 3 Postoperative pain Time after surgery . No. of studies . Mean VAS score . Mean difference . P . I2 (%) . SILC . MLC . 3 h 12 3·51 3·88 −0·34 (−0·86, 0·17) 0·19  62 4 h 8 3·64 4·15 −0·56 (−1·45, 0·33) 0·21  89 8 h 14 3·28 3·70 −0·43 (−1·12, 0·25) 0·21  93 12 h 9 2·63 3·40 −0·80 (−1·39, −0·22) 0·007 88 24 h 22 2·39 2·58 −0·20 (−0·59, 0·19) 0·31  92 48 h 8 1·42 1·91 −0·55 (−1·13, 0·04) 0·07  93 72 h 6 1·58 1·70 −0·12 (−0·74, 0·50) 0·71  95 7 days 5 1·28 1·89 0·11 (−0·54, 0·77) 0·74  88 14 days 3 0·98 1·30 −0·33 (−0·81, 0·16) 0·19  91 1 month 4 1·28 1·25 −0·16 (−0·52, 0·19) 0·37  82 Time after surgery . No. of studies . Mean VAS score . Mean difference . P . I2 (%) . SILC . MLC . 3 h 12 3·51 3·88 −0·34 (−0·86, 0·17) 0·19  62 4 h 8 3·64 4·15 −0·56 (−1·45, 0·33) 0·21  89 8 h 14 3·28 3·70 −0·43 (−1·12, 0·25) 0·21  93 12 h 9 2·63 3·40 −0·80 (−1·39, −0·22) 0·007 88 24 h 22 2·39 2·58 −0·20 (−0·59, 0·19) 0·31  92 48 h 8 1·42 1·91 −0·55 (−1·13, 0·04) 0·07  93 72 h 6 1·58 1·70 −0·12 (−0·74, 0·50) 0·71  95 7 days 5 1·28 1·89 0·11 (−0·54, 0·77) 0·74  88 14 days 3 0·98 1·30 −0·33 (−0·81, 0·16) 0·19  91 1 month 4 1·28 1·25 −0·16 (−0·52, 0·19) 0·37  82 Values in parentheses are 95 per cent confidence intervals. VAS, visual analogue scale; SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy. Open in new tab Table 3 Postoperative pain Time after surgery . No. of studies . Mean VAS score . Mean difference . P . I2 (%) . SILC . MLC . 3 h 12 3·51 3·88 −0·34 (−0·86, 0·17) 0·19  62 4 h 8 3·64 4·15 −0·56 (−1·45, 0·33) 0·21  89 8 h 14 3·28 3·70 −0·43 (−1·12, 0·25) 0·21  93 12 h 9 2·63 3·40 −0·80 (−1·39, −0·22) 0·007 88 24 h 22 2·39 2·58 −0·20 (−0·59, 0·19) 0·31  92 48 h 8 1·42 1·91 −0·55 (−1·13, 0·04) 0·07  93 72 h 6 1·58 1·70 −0·12 (−0·74, 0·50) 0·71  95 7 days 5 1·28 1·89 0·11 (−0·54, 0·77) 0·74  88 14 days 3 0·98 1·30 −0·33 (−0·81, 0·16) 0·19  91 1 month 4 1·28 1·25 −0·16 (−0·52, 0·19) 0·37  82 Time after surgery . No. of studies . Mean VAS score . Mean difference . P . I2 (%) . SILC . MLC . 3 h 12 3·51 3·88 −0·34 (−0·86, 0·17) 0·19  62 4 h 8 3·64 4·15 −0·56 (−1·45, 0·33) 0·21  89 8 h 14 3·28 3·70 −0·43 (−1·12, 0·25) 0·21  93 12 h 9 2·63 3·40 −0·80 (−1·39, −0·22) 0·007 88 24 h 22 2·39 2·58 −0·20 (−0·59, 0·19) 0·31  92 48 h 8 1·42 1·91 −0·55 (−1·13, 0·04) 0·07  93 72 h 6 1·58 1·70 −0·12 (−0·74, 0·50) 0·71  95 7 days 5 1·28 1·89 0·11 (−0·54, 0·77) 0·74  88 14 days 3 0·98 1·30 −0·33 (−0·81, 0·16) 0·19  91 1 month 4 1·28 1·25 −0·16 (−0·52, 0·19) 0·37  82 Values in parentheses are 95 per cent confidence intervals. VAS, visual analogue scale; SILC, single-incision laparoscopic cholecystectomy; MLC, multiport laparoscopic cholecystectomy. Open in new tab Twenty-four trials reported the length of hospital stay There was significant heterogeneity among the trials (I2 = 86 per cent, P < 0·001). In the random-effects model, the mean stay was similar in both groups (MD −0·05 (95 per cent c.i. –0·14 to 0·04) days; P = 0·32) (Fig. S15, supporting information). Time to return to work was reported in nine trials. There was significant heterogeneity among the trials (I2 = 86 per cent, P < 0·001). In the random-effects model, the mean time to return to work was similar in the two groups (MD −0·72 (−1·60 to 0·15) days; P = 0·10) (Fig. S16, supporting information). Complications Gallbladder perforation or bile spillage was reported in seven trials. There was no heterogeneity among the trials (I2 = 0 per cent, P = 0·64). In the fixed-effect model, the frequency of gallbladder perforation or bile spillage was similar for both groups (OR 1·33, 95 per cent c.i. 0·78 to 2·28; P = 0·29) (Fig. S17, supporting information). Retained bile duct stones that required postoperative endoscopic retrograde cholangiopancreatography were reported in seven trials. There was no heterogeneity among the five trials included in the meta-analysis (I2 = 0 per cent, P = 0·94). In the fixed-effect model, the frequency of retained bile duct stones was similar for both groups, with a trend towards more stones after SILC (OR 2·03, 0·57 to 7·27; P = 0·28) (Fig. S18, supporting information). Postoperative bile leakage was reported in eight trials. There was no heterogeneity among the six trials included in the meta-analysis (I2 = 0 per cent, P = 0·74). The fixed-effect model showed that the frequency of postoperative bile leakage was similar after both procedures (OR 1·25, 0·41 to 3·80; P = 0·69) (Fig. S19, supporting information). Only Lirici et al.38 reported one recognized intraoperative bile duct injury (BDI), a partial avulsion of a short cystic duct from the common bile duct in the MLC group. This complication required conversion to open surgery for safe repair. Sixteen trials15,19–24,26,30,32,33,35,41,45,47,49 reported whether intraoperative cholangiography (IOC) was undertaken. In these 16 studies, only 94 cholangiograms were performed in 658 SILC operations, and 105 cholangiograms in 670 MLCs. Eight of these 16 trials did not undertake cholangiography, and only two studies22,26 reported performing IOC routinely. There was no heterogeneity among the seven trials included in the meta-analysis (I2 = 0 per cent, P = 0·89). In the fixed-effect model, cholangiography was used in a similar proportion of procedures in both groups (OR 0·90, 0·52 to 1·54; P = 0·70) (Fig. S20, supporting information). Relevant intraoperative bleeding was reported in seven trials. There was no heterogeneity among the trials (I2 = 0 per cent, P = 0·56). The fixed-effect model showed no difference between the groups in the frequency of relevant intraoperative bleeding (OR 0·84, 0·36 to 1·94; P = 0·68) (Fig. S21, supporting information). Postoperative haematoma was reported in four trials. There was no heterogeneity among the trials (I2 = 0 per cent, P = 0·70). In the fixed-effect model, the frequency of haematoma was similar for both groups (OR 1·02, 0·37 to 2·86; P = 0·97) (Fig. S22, supporting information). Postoperative seroma was reported in five trials. There was no heterogeneity among the trials (I2 = 0 per cent, P = 0·87). There was no difference between the groups in the frequency of seroma (OR 0·86, 0·32 to 2·28; P = 0·76) (Fig. S23, supporting information). Wound infection was reported in 15 trials. There was no heterogeneity among the trials (I2 = 0 per cent, P = 0·93). In the fixed-effect model, the frequency of wound infection was similar after SILC and MLC (OR 1·23, 0·70 to 2·14; P = 0·47) (Fig. S24, supporting information). Postoperative pneumothorax was reported in three trials. There was no heterogeneity among the trials (I2 = 0 per cent, P = 1·00). The frequency of postoperative pneumothorax was similar for both groups in the fixed-effect model (OR 3·10, 0·48 to 20·13; P = 0·24) (Fig. S25, supporting information). Port-site hernia was reported in ten trials including 927 patients (472 SILC, 455 MLC). There was no heterogeneity among the trials (I2 = 0 per cent, P = 0·90). In the fixed-effect model, the frequency of port-site hernia was 19 of 472 (4·0 per cent) in the SILC group compared with five of 455 (1·1 per cent) in the MLC group (OR 2·50, 1·10 to 5·69; P = 0·03) (Fig. 11). The mean follow-up ranged from 4 to 69 weeks. Fig. 11 Open in new tabDownload slide Forest plot comparing rate of port-site hernia after single-incision (SILC) versus multiport (MLC) laparoscopic cholecystectomy. A Mantel–Haenszel fixed-effect model was used for meta-analysis. Odds ratios are shown with 95 per cent confidence intervals Postoperative use of analgesics Twenty-four studies reported postoperative use of analgesics in the first 24 h. A meta-analysis was not undertaken because the initial pain therapy differed greatly among the studies, and analgesics on demand also differed in substance and dose. In six studies15,17,22,26,30,35, patients in the MLC group required significantly more pain relief in the first 24 h. In the remaining 18 studies, there was no significant difference between the two groups in the first 24 h. Three studies15,30,35 reported significantly greater consumption of analgesics more than 24 h after surgery in the MLC group. In the remaining studies, there was no difference between the two groups after 24 h. Costs Five studies reported the costs of the procedure or the whole hospital stay. A meta-analysis was not performed because the costs are specific to each country. Two studies22,49 reported significantly higher costs for SILC. In the remaining three studies33,39,46, the costs were similar for the two procedures. Postoperative quality of life Nine studies reported postoperative QoL. The authors used different questionnaires at multiple time points, and a meta-analysis was not therefore possible. Brown et al.33 used the Gastrointestinal Quality of Life Index (GIQLI) before surgery, and after 2 and 4 weeks. There was no difference statistically between the two groups at any time point. Saad et al.19 used the GIQLI after 10 days and reported no difference between the two groups. Bucher and colleagues22 used the Short Form (SF) 12 (SF-12®; RAND Health Communications, Santa Monica, California, USA) before operation and after 4 weeks. There was no difference between the two groups before operation, but after 4 weeks QoL was significantly better in the SILC group. Abd Ellatif and co-workers35 used the EQ-5D™ (EuroQoL Group, Rotterdam, The Netherlands) before, and 1 week, 1 month and 6 months after surgery. There was no significant difference between the two groups at any time point. Lirici et al.38 used SF-36® after 1 month and reported no difference between the two groups. Lurje and colleagues15 used SF-36® before operation, after 3 months and after 1 year. Before operation and after 3 months there was statistically no difference between the two groups. After 1 year, QoL was significantly better in the SILC group than in the MLC group with regard to emotional well-being, physical pain, physical health and mental health. Ma et al.24 found no difference between the two groups in SF-36® scores before surgery and after 2–3 weeks. Marks and co-workers16 used SF-8® before operation, and after 1, 3, 5 and 7 days. They used SF-12® after 2 weeks and 1 month. Physical QoL scores favoured MLC over SILC statistically on day 3, after 1 week and 1 month, with no difference at other time points. Mental QoL scores were no different between the two groups. Zapf and colleagues49 used the Surgical Outcomes Measurement System before surgery, after 1 and 3 days, 1 and 3 weeks, 1 month, and 1 and 2 years. QoL showed a statistically similar postoperative course between the two groups in five of six outcome measures: physical and bowel function, fatigue, cosmesis and overall satisfaction at all time points. One outcome measure (impact of pain) favoured MLC over SILC before operation and on day 1 after surgery. Difficulty in performing procedures Three studies15,19,38 reported difficulties in performing one of these techniques compared with the other. In the study of Lurje et al.15, surgeons complained of discomfort in a significantly higher proportion of SILC procedures than MLC operations (12 of 48 versus 1 of 48 respectively). Saad and co-workers19 reported surgeons' ratings of the handling of instruments and camera, and preparation and gallbladder retrieval on a scale from 1 (very easy) to 5 (very difficult). Instrument and laparoscope handling was significantly better with the MLC than the SILC technique. Removal of the gallbladder from the abdomen was significantly easier in the SILC group. There was no difference in preparation. Lirici and colleagues38 scored difficulty of exposure and dissection on a scale from 1 (no difficulties) to 4 (most difficult). Exposure was significantly more difficult with SILC than MLC (mean score 1·5 (median 1, range 1–4) versus 2·2 (2, 1–3); P = 0·004). The difficulty of dissection was similar for both groups. Subgroup analysis A subgroup analysis of the three trials15,19,21 with an overall low risk of bias was performed. It showed two differences compared with the overall analysis. In the fixed-effect model, the postoperative pain score after 3 h was significantly higher after MLC (MD −0·97, 95 per cent c.i. –1·58 to −0·36; P = 0·002); there was no heterogeneity among the trials. In addition, there was no significant difference between the two groups in terms of port-site hernia (OR 2·55, 95 per cent c.i. 0·49 to 13·32; P = 0·27). Discussion This systematic review and meta-analysis found SILC to be associated with moderately, but statistically significantly better aesthetic results than MLC, as evaluated by the body image score and a linear score. This was shown not only for the early postoperative course, but also in mid- and long-term follow-up. Similarly, scar satisfaction, as evaluated by the cosmesis score, showed that patient satisfaction with the scar was significantly greater in the SILC group for all three time intervals evaluated. A clinically relevant improvement in body image and cosmesis scores is defined as an improvement of 20 per cent13. In the present study, the difference in body image scores between the SILC and MLC groups ranged between 8·8 and 16·7 per cent, indicating a moderate clinical benefit, whereas the cosmesis score showed an increase of 15·2–23·2 per cent in the SILC group, indicating a clinically moderate to significant improvement. Better cosmesis is one of the most frequently mentioned advantages of SILC. Although cosmesis is an important factor in body image-conscious patients, it has been claimed that, for the majority, cosmesis may be of less concern than surgeon reputation and avoidance of surgical complications52. Furthermore, after 21 months' follow-up, more than half of the patients who underwent MLC did not seem to remember the number of incisions they had53. It has also been noted that the incision experienced as the most painful, and that would therefore preferably be omitted by more than half of patients, is the umbilical type (as used as the single port in SILC)54. The overall published incidence of port-site hernia in MLC is stated to be 1·7 per cent55. The present study showed a significantly higher incidence of port-site hernia in the SILC group (4·0 per cent) compared with the MLC group (1·1 per cent) in a follow-up ranging from 1 to 17 months after surgery. Although a previous study56 showed little difference between the two techniques, recent systematic reviews9,11 have also shown a higher risk of port-site hernia with SILC. In the present review, one of the RCTs16 reported a significantly higher risk of port-site hernia for the SILC technique than the other included trials. In this study, incisional adverse events (such as wound infection) were found to be the only predictor of port-site hernia. In analyses either including or excluding this particular study, the incidence of port-site hernia was found to be higher in the SILC group. Several authors9,11,16 have claimed that a larger periumbilical incision and consequent fascial defect increase the risk of incisional hernia. It could be argued that, depending on the shape of the patient, it can be technically difficult to fix the fascia through a small skin incision. One recent retrospective study57 reported 500 consecutive procedures with no incisional hernia development after applying a two figure-of-eight knot instead of a one figure-of-eight knot in the SILC technique. Other authors58 have even postulated that approaches with multiple trocar insertions through a single skin incision may have a positive effect compared with the single fascial incision. In the present analysis, postoperative pain was similar for both techniques at all time points, apart from 12 h after surgery when patients who had SILC were found to have significantly less pain assessed by VAS than those who underwent MLC. As the difference noted was less than 1 point on a 10-point scale, the clinical importance of this finding is unclear. Many factors can affect postoperative pain, such as incision length, pneumoperitoneum pressure, use of local anaesthetics, peritoneal lavage and emotional factors. The two most recent meta-analyses showed less11 and similar9 postoperative pain respectively following SILC. However, findings for postoperative pain in recent RCTs differ considerably. In comparison with multiport procedures, SILC has been reported to cause less15,17,25,35,39,44, the same19,21,23,33,46,49 or more16,42,47 postoperative pain at various time points. Several authors10,59,60 have associated the higher pain score in SILC with the greater incisional trauma. Any new technique should be at least as safe for the patient as the established technique with which it is being compared. The present study showed that complications such as intraoperative blood loss, conversion to open cholecystectomy, gallbladder perforation, intraoperative bleeding, BDI or bile leakage, haematoma, seroma and wound infection were equally common with both techniques. Furthermore, there was no difference in length of hospital stay and time to return to work. However, BDI is considered to be the most relevant safety issue in cholecystectomy, and there have been special concerns about this with the SILC technique61,62. These retrospective studies showed a BDI rate of 0·7 per cent in the SILC group compared with 0·4–0·5 per cent in the MLC group. This is in contrast to the finding of a comparable BDI rate in the SILC and MLC groups in the present meta-analysis and another recent retrospective study57. The clinical significance of the present findings is limited by the fact that not all the included studies provided exact information on the type of biliary complications. Moreover, as the overall rate of BDI is less than 1 per cent, large numbers of patients are needed to determine the true rates61. It has also been stated previously that acute cholecystitis is not associated with a statistically different rate of BDI62; however, only three of the 37 RCTs in this meta-analysis included patients with acute cholecystitis, accounting for just 11·4 per cent of patients. It therefore remains unclear whether there will be a greater risk of BDI in the future with the (often seen) natural progression of a new technique to broader indications, such acute cholecystitis. Of interest, many surgeons perform intraoperative cholangiography (IOC) routinely with the aim of minimizing the risk of BDI. In the present study, IOC was used routinely in two RCTs22,26. In total, IOC was used in only 199 of 1328 interventions (15·0 per cent). This low rate could reflect a higher level of difficulty in performing IOC with a single-incision technique. There was a trend towards a higher risk of pneumothorax after SILC, with three instances in the SILC group and none in the MLC group. The cause in one patient was the needle used to stitch the gallbladder to the peritoneum for traction51, and the pneumothorax regressed spontaneously with conservative therapy. In a second patient, pneumothorax was caused by a laparoscopic forceps used for retracting the gallbladder, which slipped and injured the right diaphragm19. In the final patient, a pneumothorax apparently occurred spontaneously after operation in a patient with a history of smoking and chronic obstructive pulmonary disease. This patient required interventional chest-tube placement15. Pneumothorax after laparoscopic cholecystectomy is extremely rare63. Only two other studies reporting pneumothorax after laparoscopic cholecystectomy have been found in the literature. Kurpiewski and colleagues64 reported two cases in a study of 100 patients undergoing SILC. Both occurred directly after putting the suspension suture into the gallbladder fundus via the seventh intercostal space. Łosin et al.65 reported their first experience of three children treated with SILC. In one patient, a small pneumothorax probably resulted from placement of a relatively high stay suture. Most of these cases show that suspension sutures, which are often used in SILC, may increase the risk of pneumothorax. The present meta-analysis has shown that there are many RCTs indicating the cosmetic superiority of SILC compared with MLC without compromising patient safety. However, this finding is not reflected in common practice where MLC remains the routine approach to benign gallbladder disease. The reasons for this are not entirely clear. The duration of surgery is significantly longer for SILC. This may be due to lack of training and/or the increased technical difficulty of SILC. Several studies66–69 have shown that the learning curve for SILC is short, with complication rates similar to those of MLC performed by the same surgeons or rates in the literature. This refutes the argument that SILC is too difficult to perform. Surgeons need 15 min longer to perform SILC compared with MLC9,11 which, in the authors' opinion, has limited clinical implication. Recently, it has been reported that surgeons find SILC more stressful and physically demanding to perform than MLC70, and Lurje et al.15 noted that surgeons more commonly reported discomfort while performing SILC than MLC. More significantly, the fear of higher costs22,49 and of higher rates of port-site hernia may be preventing many clinics from introducing SILC. Another important factor could be the fact that the majority of patients receiving laparoscopic cholecystectomy are not focused on cosmesis, but on safety and freedom from symptoms. The present meta-analysis has several limitations. First, the quality of the systematic review is partially determined by the quality of the included RCTs. Only three15,19,21 of the 37 included trials had an overall low risk of bias. There were significant differences in the inclusion and exclusion criteria among the included trials, including whether emergency laparoscopic cholecystectomies were included. Shortcomings of the RCTs include small numbers of patients in most of the trials (20–50 per group). In addition, only six trials15,17,19,21,44,49 were double-blinded. Another problem is the short follow-up. Only eight studies15–17,19,21,46,47,49 reported a follow-up of 1 year or longer. Differences may have been missed owing to the high degree of heterogeneity between the studies. Two larger RCTs71,72 have been published since the literature search for this review was completed in September 2015. Arezzo and colleagues72 used a five-question item to evaluate the cosmetic result and did not employ any of the three scores analysed here. Guo and co-workers71 did not evaluate the cosmetic outcome. As the cosmetic result is the primary focus of the present study, the authors consider it justifiable not to include these two recent publications. Guo et al.71 stated that the primary benefit of SILC appears to be slightly less pain immediately after surgery, consistent with the present findings. Arezzo and colleagues72 concluded that SILC is not inferior to MLC in terms of safety in selected patients undergoing cholecystectomy for benign gallbladder disease, but takes longer. An incisional hernia developed within 1 year in six patients in the SILC group and in three in the MLC group, which was not statistically significant. In the present study, SILC provided better cosmesis and satisfaction with the wound than traditional MLC for up to a year after surgery, with comparable rates of postoperative complications, making it a safe procedure in non-obese patients in an elective setting. 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TI - Meta-analysis of single-port versus conventional laparoscopic cholecystectomy comparing body image and cosmesis
JO - British Journal of Surgery
DO - 10.1002/bjs.10574
DA - 2017-07-13
UR - https://www.deepdyve.com/lp/oxford-university-press/meta-analysis-of-single-port-versus-conventional-laparoscopic-mBLRaQkh3v
SP - 1141
EP - 1159
VL - 104
IS - 9
DP - DeepDyve
ER -