TY - JOUR
AU - Lee, P-H
AB - Abstract Background Transumbilical single-incision laparoscopic cholecystectomy (SILC) and minilaparoscopic cholecystectomy (MLC) are both increasingly being used to treat symptomatic gallstones. The present study compared SILC and MLC with respect to outcome in a prospective randomized trial. Methods Seventy patients with symptomatic cholelithiasis were randomized to SILC or MLC (35 in each group). The primary outcome measure was postoperative pain. Secondary outcomes were duration of operation, complications, postoperative analgesic requirements, length of hospital stay, cosmetic result, wound length and time to return to work. Results Surgical complications, postoperative pain scores, analgesic requirements and time to return to work were similar for both procedures. Statistically significant advantages of SILC were a shorter hospital stay, shorter total wound length and better cosmetic appearance. Duration of operation was significantly shorter for MLC. Conclusion SILC is superior to MLC in terms of cosmetic outcome, but not in postoperative pain and requirement for analgesics. Introduction Since its introduction in 1989, laparoscopic cholecystectomy has evolved to become the standard procedure for gallbladder removal. In 1997, minilaparoscopic cholecystectomy (MLC) was introduced to reduce the morbidity of surgical wounds1. More recently, natural orifice transluminal endoscopic surgery (NOTES)2–4 has become available, but this approach suffers from limitations of current technology. Against this background, totally transumbilical single-port surgery (TUSPS)5,6, also known as laparoendoscopic single-site (LESS) surgery7, single-incision laparoscopic surgery (SILS)8 or single-incision multiport laparoendoscopic (SIMPLE) surgery9, has emerged as a more feasible minimally invasive approach. Some centres have begun performing single-port access surgery to improve cosmesis and potentially reduce postoperative pain10,11. Single-incision laparoscopic cholecystectomy (SILC) for patients with symptomatic gallstones can be performed with traditional laparoscopic skills and using existing laparoscopic instruments. Because of the single and smaller wound, SILC could theoretically cause less postoperative pain and provide a better cosmetic outcome than MLC. This hypothesis was assessed in the present randomized trial in which MLC and SILC were compared in patients with symptomatic gallstones. Methods Between 1 September 2008 and 10 April 2009, 88 patients with symptomatic cholelithiasis, verified by abdominal ultrasonography, who were scheduled for elective cholecystectomy were considered for the study (Fig. 1). Fig. 1 Open in new tabDownload slide CONSORT diagram for trial. SILC, single-incision laparoscopic cholecystectomy; MLC, minilaparoscopic cholecystectomy The study protocol was explained to all patients, and they understood they would be selected randomly to undergo either SILC or MLC. All patients provided informed consent to participate in the trial and for the surgical procedure. Patients were randomized to receive SILC or MLC using a blinded envelope system. All operations were performed by the same surgeon, who had experience of over 100 MLC and 20 SILC procedures. The study was approved by the institutional review board of the hospital. Surgical procedures SILC was performed as follows under general anaesthesia. A 1·5-cm intraumbilical vertical skin incision was made to perform the minilaparotomy. A wound retractor was inserted through the umbilical incision as described previously12 (Fig. 2). The QuadraPort® Laparoscopic Access Device (LAGIS, Taichung County, Taiwan, developed in the authors' institution) is a novel laparoscopic multichannel access system consisting of four ports for one rigid 30° 5-mm laparoscope, one 5-mm laparoscopic instrument and one 3-mm endograsper (Figs 3 and 4). It allows these instruments to be passed simultaneously through the single incision. The remaining port is designed for a 10-mm instrument, such as endoclips for cystic duct clipping or an endograsper for gallbladder retrieval. The device also prevents air leakage and ensures an adequate pneumoperitoneum once it has been capped on the wound retractor. The operating steps were similar to those of MLC. If the infundibulum of the gallbladder could not be retracted upward and laterally by the 3-mm endograsper, a 2/0 polypropylene suture method of retraction was performed7. The cystic artery was divided by bipolar electrocautery. The cystic duct was divided with endoscopic scissors following ligation with three 10-mm clips after establishing the critical view of safety. Once the gallbladder was free from the liver bed, it was removed using a 10-mm endograsper and wound retractor. The umbilical fascia was closed with a 2/0 Vicryl® suture (Ethicon, Cincinnati, Ohio, USA). Fig. 2 Open in new tabDownload slide Umbilical incision with wound retractor in place Fig. 3 Open in new tabDownload slide QuadraPort® Laparoscopic Access Device being placed over wound retractor Fig. 4 Open in new tabDownload slide QuadraPort® Laparoscopic Access Device in position over wound retractor MLC was performed as described previously1,13. A standard 10-mm cannula and 10-mm laparoscope were introduced via a 10-mm infraumbilical incision. Three MiniSite® disposable 3-mm introducer Surgineedle® instrument combinations (US Surgical Corporation, Norwalk, Connecticut, USA) were inserted in the subxiphoid, right midclavicular and right anterior axillary regions. The cystic artery was divided by bipolar electrocautery. The cystic duct was clipped and divided (after establishing the critical view of safety) with 10-mm laparoscopic instruments through the subumbilical port while being visualized through a 3-mm minilaparoscope in the subxiphoid port. The gallbladder was extracted through the subumbilical port and the fascial defect of the subumbilical wound was closed with a 2/0 Vicryl® suture. For either procedure, if bile spillage occurred during the operation, the region was irrigated with normal saline and dried by endoscopic suction or the use of wet gauze swabs. Outcomes The primary outcome measure was postoperative pain. Secondary outcomes were duration of operation, complications, postoperative analgesic requirements, length of hospital stay, cosmetic result, wound length and time to return to work. All patients followed a standard analgesic protocol with oral paracetamol (500 mg four times daily) and intramuscular pethidine (1 mg/kg every 6 h) according to individual need. An independent observer who was blinded to the method of surgery obtained a pain score on a visual analogue scale (VAS) ranging from 1 (minimal discomfort) to 10 (unbearable pain) on the morning of the day after surgery. Duration of operation was defined as the interval between the initial skin incision and skin closure. Surgical complications were classified as described by Dindo and colleagues14. Hospital stay was defined as the number of days spent in hospital after surgery. For patients discharged on the day of operation, the hospital stay was counted as 1 day; these patients were required to return to the outpatient clinic the following day for VAS assessment. Time to return to work was defined as the interval from the date of discharge to the date of return to work. Cosmetic outcome was self-assessed by all patients 1 and 6 months after surgery using a scale ranging from 1 (poor) to 10 (excellent). During follow-up visits a questionnaire written in the patient's native language was administered, which partly considered the appearance of scars. Statistical analysis The hypothesis was that MLC would cause more pain than SILC measured by VAS scores. It was assumed that a 0·5 difference in VAS score between the groups would indicate a clinically important difference in pain. It was calculated that this difference could be detected by a single-tail test with α = 0·05 (power 90 per cent), and 35 patients in each group. Data were analysed based on an intention-to-treat principle. The results for SILC and MLC groups were compared using Student's t test and χ2 test or Fisher's exact test, as appropriate. P < 0·050 was considered statistically significant. Data analysis was carried out using SPSS® version 9.0 statistical software (SPSS, Chicago, Illinois, USA). Results Of 88 patients considered for the study, 16 were excluded for a variety of reasons, such as acute cholecystitis (based on clinical and ultrasonographic findings), clinical evidence of common bile duct stones, severe obesity and previous upper abdominal surgery. Two patients refused to participate in the study. Seventy patients with symptomatic cholelithiasis who met the criteria of the American Society of Anesthesiologists classification I or II were randomly assigned to SILC or MLC (35 in each group) (Fig. 1). The two groups were similar with respect to sex, age, body mass index and pathology (Table 1). Two patients undergoing SILC underwent placement of an additional 5-mm trocar away from the umbilicus to facilitate exposure and placement of a 7-mm vacuum wound drain. One patient in the MLC group underwent laparoscopic cholecystectomy using two 5-mm trocars owing to a densely fibrotic gallbladder. The SILC procedure took significantly longer than MLC (71·7(11·6) versus (48·4(10·5) min; P < 0·001). Table 1 Patient characteristics . SILC (n = 35) . MLC (n = 35) . P . Age (years)* 51·0(13·5) (30–76) 53·3(15·5) (23–84) 0·512† Sex ratio (F : M) 22 : 13 20 : 15 0·807‡ Body mass index (kg/m2)* 24·2(3·4) (18·5–29·5) 25·8(3·0) (19·8–29·7) 0·053† Pathology 0·513§  Chronic cholecystitis 22 25  Cholelithiasis 10 6  Cholesterolosis 3 4 No. of conversions to other procedure 2 1 1·000§ . SILC (n = 35) . MLC (n = 35) . P . Age (years)* 51·0(13·5) (30–76) 53·3(15·5) (23–84) 0·512† Sex ratio (F : M) 22 : 13 20 : 15 0·807‡ Body mass index (kg/m2)* 24·2(3·4) (18·5–29·5) 25·8(3·0) (19·8–29·7) 0·053† Pathology 0·513§  Chronic cholecystitis 22 25  Cholelithiasis 10 6  Cholesterolosis 3 4 No. of conversions to other procedure 2 1 1·000§ * Values are mean(s.d.) (range). SILC, single-incision laparoscopic cholecystectomy; MLC, minilaparoscopic cholecystectomy. † Student's t test; ‡ χ2 test; § Fisher's exact test. Open in new tab Table 1 Patient characteristics . SILC (n = 35) . MLC (n = 35) . P . Age (years)* 51·0(13·5) (30–76) 53·3(15·5) (23–84) 0·512† Sex ratio (F : M) 22 : 13 20 : 15 0·807‡ Body mass index (kg/m2)* 24·2(3·4) (18·5–29·5) 25·8(3·0) (19·8–29·7) 0·053† Pathology 0·513§  Chronic cholecystitis 22 25  Cholelithiasis 10 6  Cholesterolosis 3 4 No. of conversions to other procedure 2 1 1·000§ . SILC (n = 35) . MLC (n = 35) . P . Age (years)* 51·0(13·5) (30–76) 53·3(15·5) (23–84) 0·512† Sex ratio (F : M) 22 : 13 20 : 15 0·807‡ Body mass index (kg/m2)* 24·2(3·4) (18·5–29·5) 25·8(3·0) (19·8–29·7) 0·053† Pathology 0·513§  Chronic cholecystitis 22 25  Cholelithiasis 10 6  Cholesterolosis 3 4 No. of conversions to other procedure 2 1 1·000§ * Values are mean(s.d.) (range). SILC, single-incision laparoscopic cholecystectomy; MLC, minilaparoscopic cholecystectomy. † Student's t test; ‡ χ2 test; § Fisher's exact test. Open in new tab Clinical results are presented in Table 2. The pain score on day 1 after surgery was similar in the SILC and MLC groups (2·1(0·9) versus 2·2(0·8); P = 0·477) and there was no significant difference in the postoperative administration of pethidine (0·40(0·44) versus 0·34(0·38) mg/kg respectively; P = 0·567). The length of hospital stay was significantly shorter after SILC (2·4(0·8) versus (2·9(0·4) days; P = 0·002). Three patients in the SILC group were discharged on the day of operation. Table 2 Operative data and outcome . SILC (n = 35) . MLC (n = 35) . P§ . Duration of operation (min)* 71·7(11·6) (45–100) 48·4(10·5) (30–75) < 0·001 Length of hospital stay (days)* 2·4(0·8) (1–4) 2·9(0·4) (2–4) 0·002 Complications  Bile duct injury 0 0  Cystic artery bleeding 0 0  Bile spillage 6 4 0·732¶  Wound infection 0 0  Urinary retention 1 1 1·000¶ Pethidine dose (mg/kg)* 0·40(0·44) (0–3) 0·34(0·38) (0–2) 0·567 Pain score (VAS)*† 2·1(0·9) (1–4) 2·2(0·8) (1–4) 0·477# Cosmetic result*‡  1 month 8·7(1·0) (6–10) 7·7(1·4) (4–10) 0·001  6 months 9·1(1·0) (6–10) 8·4(1·1) (5–10) 0·042 Time to return to work (days)* 5·3(2·0) (2–9) 5·9(2·3) (2–12) 0·274 Wound length (mm)* 15·7(1·0) (14–18) 20·9(1·4) (19–25) < 0·001 . SILC (n = 35) . MLC (n = 35) . P§ . Duration of operation (min)* 71·7(11·6) (45–100) 48·4(10·5) (30–75) < 0·001 Length of hospital stay (days)* 2·4(0·8) (1–4) 2·9(0·4) (2–4) 0·002 Complications  Bile duct injury 0 0  Cystic artery bleeding 0 0  Bile spillage 6 4 0·732¶  Wound infection 0 0  Urinary retention 1 1 1·000¶ Pethidine dose (mg/kg)* 0·40(0·44) (0–3) 0·34(0·38) (0–2) 0·567 Pain score (VAS)*† 2·1(0·9) (1–4) 2·2(0·8) (1–4) 0·477# Cosmetic result*‡  1 month 8·7(1·0) (6–10) 7·7(1·4) (4–10) 0·001  6 months 9·1(1·0) (6–10) 8·4(1·1) (5–10) 0·042 Time to return to work (days)* 5·3(2·0) (2–9) 5·9(2·3) (2–12) 0·274 Wound length (mm)* 15·7(1·0) (14–18) 20·9(1·4) (19–25) < 0·001 * Values are mean(s.d.) (range). † Visual analogue scale (VAS) ranged from 0 to 10. ‡ Cosmetic result assessed by the patient on a scale from 1 to 10 (10 is best). SILC, single-incision laparoscopic cholecystectomy; MLC, minilaparoscopic cholecystectomy. § Student's t test, except ¶ Fisher's exact test; # Mann–Whitney U test. Open in new tab Table 2 Operative data and outcome . SILC (n = 35) . MLC (n = 35) . P§ . Duration of operation (min)* 71·7(11·6) (45–100) 48·4(10·5) (30–75) < 0·001 Length of hospital stay (days)* 2·4(0·8) (1–4) 2·9(0·4) (2–4) 0·002 Complications  Bile duct injury 0 0  Cystic artery bleeding 0 0  Bile spillage 6 4 0·732¶  Wound infection 0 0  Urinary retention 1 1 1·000¶ Pethidine dose (mg/kg)* 0·40(0·44) (0–3) 0·34(0·38) (0–2) 0·567 Pain score (VAS)*† 2·1(0·9) (1–4) 2·2(0·8) (1–4) 0·477# Cosmetic result*‡  1 month 8·7(1·0) (6–10) 7·7(1·4) (4–10) 0·001  6 months 9·1(1·0) (6–10) 8·4(1·1) (5–10) 0·042 Time to return to work (days)* 5·3(2·0) (2–9) 5·9(2·3) (2–12) 0·274 Wound length (mm)* 15·7(1·0) (14–18) 20·9(1·4) (19–25) < 0·001 . SILC (n = 35) . MLC (n = 35) . P§ . Duration of operation (min)* 71·7(11·6) (45–100) 48·4(10·5) (30–75) < 0·001 Length of hospital stay (days)* 2·4(0·8) (1–4) 2·9(0·4) (2–4) 0·002 Complications  Bile duct injury 0 0  Cystic artery bleeding 0 0  Bile spillage 6 4 0·732¶  Wound infection 0 0  Urinary retention 1 1 1·000¶ Pethidine dose (mg/kg)* 0·40(0·44) (0–3) 0·34(0·38) (0–2) 0·567 Pain score (VAS)*† 2·1(0·9) (1–4) 2·2(0·8) (1–4) 0·477# Cosmetic result*‡  1 month 8·7(1·0) (6–10) 7·7(1·4) (4–10) 0·001  6 months 9·1(1·0) (6–10) 8·4(1·1) (5–10) 0·042 Time to return to work (days)* 5·3(2·0) (2–9) 5·9(2·3) (2–12) 0·274 Wound length (mm)* 15·7(1·0) (14–18) 20·9(1·4) (19–25) < 0·001 * Values are mean(s.d.) (range). † Visual analogue scale (VAS) ranged from 0 to 10. ‡ Cosmetic result assessed by the patient on a scale from 1 to 10 (10 is best). SILC, single-incision laparoscopic cholecystectomy; MLC, minilaparoscopic cholecystectomy. § Student's t test, except ¶ Fisher's exact test; # Mann–Whitney U test. Open in new tab There were no instances of biliary injury or bleeding from the cystic artery. Six patients in the SILC group experienced bile spillage owing to intraoperative gallbladder rupture or gallbladder penetration during suturing with 2/0 polypropylene, and four in the MLC group had bile spillage as a result of intraoperative gallbladder rupture. The spillage was cleared in all patients and none experienced major postoperative complications. Bile spillage showed a significant association with pain score and pethidine requirement (Table 3). Table 3 Postoperative pethidine dose and pain score in patients with and without bile spillage . Bile spillage (n = 10) . No bile spillage (n = 60) . P . Pethidine dose (mg/kg) 1·03(0·41) (0–3) 0·26(0·30) (0–2) < 0·001* Pain score (VAS) 2·6(1·2) (1–4) 2·1(0·8) (1–4) 0·053† . Bile spillage (n = 10) . No bile spillage (n = 60) . P . Pethidine dose (mg/kg) 1·03(0·41) (0–3) 0·26(0·30) (0–2) < 0·001* Pain score (VAS) 2·6(1·2) (1–4) 2·1(0·8) (1–4) 0·053† Values are as mean(s.d.) (range). VAS, visual analogue scale. * Student's t test; † Mann–Whitney U test. Open in new tab Table 3 Postoperative pethidine dose and pain score in patients with and without bile spillage . Bile spillage (n = 10) . No bile spillage (n = 60) . P . Pethidine dose (mg/kg) 1·03(0·41) (0–3) 0·26(0·30) (0–2) < 0·001* Pain score (VAS) 2·6(1·2) (1–4) 2·1(0·8) (1–4) 0·053† . Bile spillage (n = 10) . No bile spillage (n = 60) . P . Pethidine dose (mg/kg) 1·03(0·41) (0–3) 0·26(0·30) (0–2) < 0·001* Pain score (VAS) 2·6(1·2) (1–4) 2·1(0·8) (1–4) 0·053† Values are as mean(s.d.) (range). VAS, visual analogue scale. * Student's t test; † Mann–Whitney U test. Open in new tab There was no difference in time to return to work between SILC and MLC groups (5·3(2·0) versus 5·9(2·3) days respectively; P = 0·274). Self-assessed monitoring established that SILC produced significantly better cosmetic results than MLC at both 1 and 6 months after surgery (P = 0·001 and P = 0·042 respectively). The total wound length was significantly longer in the MLC than the SILC procedure (20·9(1·4) versus 15·7(1·0) mm; P < 0·001). Discussion Laparoscopic surgery has developed rapidly in recent years. To minimize access-related injuries and complications, NOTES15,16 was introduced, and more recently single-port access laparoscopy (SPA)11,17 and TUSPS5,6 have been developed. In contrast to NOTES, TUSPS does not require the opening of a hollow organ. Although the risk of complications related to visceral closure is very low in NOTES, such complications are avoided with SPA or TUSPS. SILC using a transumbilical access was introduced more recently. This method has potential as a new variant of laparoscopic procedures that is associated with less scar formation11. In this randomized trial of SILC versus MLC, SILC had the advantage of a shorter hospital stay and better cosmetic result owing to the shorter wound length. However, there was no difference in VAS pain score or postoperative analgesic administration. Intraoperative bile spillage was strongly associated with postoperative analgesic administration and VAS pain score. The most common presenting symptom of bile leakage is abdominal pain18 due to peritoneal irritation and inflammation. This may explain why patients with intraoperative bile spillage felt more discomfort on the day after surgery and required more analgesics. Bile spillage was caused by gallbladder rupture or gallbladder penetration during suturing with 2/0 polypropylene. To avoid this complication during SILC, precise seromuscular suturing using 2/0 polypropylene without penetration of the gallbladder fundus is essential. Furthermore, gentle traction using an atraumatic endograsper and meticulous electrocautery dissection of the gallbladder from the liver bed during SILC and MLC is important. The mean duration of operation for SILC of 71·7 min in the study is similar to that reported previously (72 min)7. Even though the procedures in the study were performed by an experienced surgeon, SILC took more than 20 min longer to perform than MLC. The extended duration of SILC reflects the limited space available through the single incision and the difficulty in manipulating the instruments11. The operating time for SILC will probably be reduced in the future with the introduction of more flexible instruments that provide better exposure of the operative field, and instruments that can be held more firmly, even with articulations. Several instruments have been developed at the authors' institution of varying lengths, some of which are flexible with articulations. Because of absorbed carbon dioxide and raised intra-abdominal pressure, carbon dioxide pneumoperitoneum has potentially harmful intraoperative circulatory and ventilatory effects, and leads to oxidative stress19. A prolonged operation may exacerbate the cardiopulmonary insult related to carbon dioxide pneumoperitoneum. The shorter operating time for MLC is advantageous in this regard, and may reduce complications associated with carbon dioxide pneumoperitoneum. In the present study, the mean length of hospital stay was half a day longer in the MLC group than in the SILC group. This is because some patients who underwent SILC were discharged on the day of surgery. The shorter hospital stay may be relevant in terms of possibility of lower hospital costs related to nursing care, although this was not assessed in the present study protocol. Discharge on the day of surgery is rare following MLC. There was no difference in the length of time to return to work between the groups, probably because the two procedures caused similar levels of discomfort and pain. SILC is an alternative to traditional laparoscopic cholecystectomy in selected patients, despite its longer duration. In high-risk patients, the operating time is of more concern than the cosmetic result, making conventional laparoscopic cholecystectomy more appropriate20. MLC is therefore the better choice for patients with symptomatic gallstones from the standpoint of duration of operation. Acknowledgements P.-C.L. and C.L were joint first authors of this report. The authors declare no conflict of interest. References 1 Yuan RH , Lee WJ, Yu SC. Mini-laparoscopic cholecystectomy: a cosmetically better, almost scarless procedure . J Laparoendosc Adv Surg Tech A 1997 ; 7 : 205 – 211 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Forgione A , Maggioni D, Sansonna F, Ferrari C, Di Lernia S, Citterio et al. 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Google Scholar Crossref Search ADS PubMed WorldCat 20 Koivusalo AM , Pere P, Valjus M, Scheinin T. Laparoscopic cholecystectomy with carbon dioxide pneumoperitoneum is safe even for high-risk patients . Surg Endosc 2008 ; 22 : 61 – 67 . Google Scholar Crossref Search ADS PubMed WorldCat Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
TI - Randomized clinical trial of single-incision laparoscopic cholecystectomy versus minilaparoscopic cholecystectomy
JO - British Journal of Surgery
DO - 10.1002/bjs.7087
DA - 2010-06-02
UR - https://www.deepdyve.com/lp/oxford-university-press/randomized-clinical-trial-of-single-incision-laparoscopic-cjOu3IKDlY
SP - 1007
EP - 1012
VL - 97
IS - 7
DP - DeepDyve
ER -