TY - JOUR AU - Nagino, M AB - Abstract Background Few larger studies have estimated the incidence of incisional hernia (IH) after abdominal surgery. Methods Patients who had abdominal surgery between November 2009 and February 2011 were included in the study. The incidence rate and risk factors for IH were monitored for at least 180 days. Results A total of 4305 consecutive patients were registered. Of these, 378 were excluded because of failure to complete follow-up and 3927 patients were analysed. IH was diagnosed in 318 patients. The estimated incidence rates for IH were 5·2 per cent at 12 months and 10·3 per cent at 24 months. In multivariable analysis, wound classification III and IV (hazard ratio (HR) 2·26, 95 per cent confidence interval 1·52 to 3·35), body mass index of 25 kg/m2 or higher (HR 1·76, 1·35 to 2·30), midline incision (HR 1·74, 1·28 to 2·38), incisional surgical-site infection (I-SSI) (HR 1·68, 1·24 to 2·28), preoperative chemotherapy (HR 1·61, 1·08 to 2·37), blood transfusion (HR 1·46, 1·04 to 2·05), increasing age by 10-year interval (HR 1·30, 1·16 to 1·45), female sex (HR 1·26, 1·01 to 1·59) and thickness of subcutaneous tissue for every 1-cm increase (HR 1·18, 1·03 to 1·35) were identified as independent risk factors. Compared with superficial I-SSI, deep I-SSI was more strongly associated with the development of IH. Conclusion Although there are several risk factors for IH, reducing I-SSI is an important step in the prevention of IH. Registration number: UMIN000004723 (University Hospital Medical Information Network, http://www.umin.ac.jp/ctr/index.htm). Introduction Incisional hernia (IH) is one of the most common postoperative complications following abdominal surgery. Patients with symptomatic IH have unsatisfactory cosmetic results and impaired quality of life with serious life-threatening disorders, including incarceration (6–15 per cent) and bowel strangulation (2 per cent)1–5. The rate of recurrence after hernia repair is high (14–63 per cent)4–7. The identification of risk factors is important in the prevention of IH. In previous reports1–3,8–24, incidence rates of IH have varied from zero to 33 per cent. One reason for this may be retrospective data collection with different definitions of IH. Only a few prospective observational studies8–9,12,15–17 have analysed the occurrence of IH, and the numbers of patients in these studies have been small. As many as 80–95 per cent of patients with IH develop this complication within 6 months to 3 years after the initial operation9,10, so to estimate the incidence of IH, patients should be monitored for at least 6 months. Approximately 60 per cent of patients with IH are asymptomatic; thus, in the absence of common diagnostic criteria, the true incidence rate of IH may be underestimated1,2. Various independent risk factors for IH have been reported in previous studies, including sex (male11,18–19 and female14), advanced age8,11, co-morbidities (diabetes mellitus13 and chronic obstructive pulmonary disease10), current smoking11, systemic use of steroids20, high body mass index (BMI)12–13,18–20, previous laparotomy11,20, emergency surgery21, laparoscopic surgery15,22, duration of surgery13,19, blood transfusion10, optimal method and material for abdominal closure1,3,12,19,25, incision type19–20,23, wound dehiscence26, and surgical-site infection (SSI) including incisional SSI (I-SSI)8,11–12,14,18–19,24 and organ/space SSI (OS-SSI)12,13. Several reports have shown that I-SSI is one of the most important risk factors for IH, but no large-scale study has analysed the risk factors for IH by distinguishing superficial (SI-SSI) and deep (DI-SSI) I-SSI. This prospective observational study aimed to evaluate the rate of IH after abdominal surgery and to assess the impact of perioperative factors on the risk of IH. Among perioperative factors, postoperative wound complications, I-SSI and the depth of I-SSI were analysed specifically. Methods Patients who underwent abdominal surgery between November 2009 and February 2011 at Nagoya University Hospital and the 19 affiliated hospitals were enrolled. The eligibility criteria for this study were: age over 20 years; intra-abdominal surgery; no incision other than in the abdomen or perineum; and no artificial implant. Patients who did not have organ resection (for example bypass surgery of the digestive tract, surgery for bowel obstruction due to adhesions, and stoma creation and closure) were included in the study. Emergency surgery other than for trauma was also included. Patients who had laparoscopically assisted operations with small incisions were included, but those who had purely laparoscopic operations with only port-site wounds were excluded. Patients who underwent laparotomy or digestive bypass surgery for unresectable malignant disease were excluded from the study, as were patients who had gastric bypass surgery or banding for morbid obesity. Patients undergoing reoperation because of complete wound dehiscence of all layers within 30 days of operation were also excluded. Finally, patients without IH who died or were lost to follow-up within 180 days of surgery were excluded from the analysis of IH. The primary endpoint of this study was the rate of IH. Risk factors for IH were also analysed. The protocol was approved by the institutional review boards of Nagoya University Graduate School of Medicine and the participating hospitals, and the study design was registered with Infrastructure for Academic Activities with the University Hospital Medical Information Network Identifier (UMIN000004723, http://www.umin.ac.jp/ctr/index.htm). Informed consent was obtained from each patient before enrolment in the study. Monitored perioperative factors Data were recorded by the surgeons in charge of data collection in each hospital. Preoperative clinical data included age, sex, BMI, American Society of Anesthesiologists grade27, co-morbidities (hypertension, diabetes mellitus, chronic obstructive pulmonary disease, collagen disease and aortic aneurysm), current smoking within 1 month before surgery, previous medical history (such as laparotomy or chemotherapy), subcutaneous fat thickness, and indication for surgery. Subcutaneous fat thickness was measured before surgery by computed tomography (CT) at the thickest location of the incision. Intraoperative factors included operative status (elective or emergency), wound classification (class I, clean; class II, clean-contaminated; class III, contaminated; class IV, dirty-infected)27, duration of operation, blood loss, intraoperative blood transfusion, open or laparoscopically assisted laparotomy, operative procedure (gastric, colorectal, hepatopancreatobiliary or other surgery), wound length, method of fascial closure and type of incision. Postoperative factors included I-SSI, OS-SSI, remote infection and other postoperative complications27,28. Postoperative complications were graded according to the Dindo–Clavien classification28. Centers for Disease Control and Prevention definitions of SSI were employed27. Incisional SSI included SI-SSI and DI-SSI. SI-SSI was diagnosed when the condition occurred within 30 days of operation and involved the skin and subcutaneous tissue and one of the following: purulent discharge; organism isolated from aseptically obtained fluid or tissue; signs or symptoms of infection, including pain/tenderness, localized swelling, redness/heat and an open wound; or diagnosis of SI-SSI by a surgeon or attending physician. DI-SSI was diagnosed when the infected wound involved fascial and muscle layers but not the organ/space. The definition and diagnostic method of DI-SSI were discussed rigorously and standardized among the institutions. OS-SSI was diagnosed when the condition occurred within 30 days of surgery and involved any organ or space other than the incision, and at least one of the following: purulent drainage from a drain that was placed through a stab wound into the organ or space; organisms isolated from an aseptically obtained fluid or tissue in the organ/space; an abscess or other evidence of infection involving the organ/space that was found on direct examination, during reoperation, or by histopathological or radiological examination; or an OS-SSI diagnosed by a surgeon or attending physician. Remote infection included infections of the lower respiratory tract, urinary tract or gastrointestinal tract29. Definition, diagnosis and follow-up of incisional hernia After surgery, patients were followed up daily during the hospital stay, and perioperative data were recorded in a database. All patients were monitored for more than 180 days after the operation. The presence of IH was evaluated only for the abdominal wound and not for the perineal incisions, irrespective of symptoms2,25. After hospital discharge, patients underwent physical examination by the surgeon every 3 months to assess the presence of IH. Imaging, including CT and ultrasound examination, was used when necessary. Methods and definitions of IH diagnosis were2,11,19–20,23–25,30–31: physical examination to detect any fascial gap or protrusion with a relaxed and tensed abdominal wall in supine and standing positions; fascial gap or separation in axial images on CT; full-layer defect of fascia and muscles of the abdominal wall on ultrasonography. Statistical analysis Differences among categorical variables were evaluated using χ2 tests. Incidence rates for IH were calculated by means of the Kaplan–Meier method for estimating crude risk. The log rank test was used to compare risk factors. For patients who died after 180 days of follow-up, the date of diagnosis of IH (not the time of death) was used for the Kaplan–Meier analysis. The stepwise forward Cox regression model was used to calculate hazard ratios (HRs) with 95 per cent confidence interval (c.i.), and to estimate HRs adjusted for confounding factors. The proportionality of hazards was examined graphically using log minus log survival curves. To have 80 per cent power to detect a HR for IH of 1·33 at the 5 per cent significance level between patients with and those without SSI, at least 3800 patients needed to be accrued for the study under the assumption that 10 per cent of patients develop SSI. P < 0·050 was considered statistically significant. Data analyses were performed using SPSS® statistical software version 21 (IBM, Armonk, New York, USA). Results Between November 2009 and February 2011, 4305 consecutive patients were registered. Some 378 patients could not be followed for up to 180 days owing to death (147 patients), for unknown reasons (142) or reoperation for reasons unrelated to IH (89). Of 17 patients with total wound dehiscence, three underwent primary wound closure. A total of 3927 patients with complete data were analysed. Table 1 shows the clinical characteristics of the patients. The number of emergency surgeries and laparoscopically assisted operations was small. The majority of wounds were classified as class II. Interrupted braid or monofilament absorbable sutures were used in the most patients for wound closure. Among patients with I-SSI, 290 (7·4 per cent) had SI-SSI and 61 (1·6 per cent) had DI-SSI. Table 1 Clinical characteristics . . . No. of patients (n = 3927)* . Preoperative factors Age (years)† 69 (20–96) Sex ratio (M : F) 2506 : 1421 Body mass index (kg/m2)† 21·9 (13·1–42·3) ASA grade I 1662 (42·3) II 2089 (53·2) III 158 (4·0) IV 18 (0·5) Co-morbidity 2265 (57·7) Hypertension 1451 (36·9) Diabetes mellitus 739 (18·8) COPD 126 (3·2) Collagen disease 53 (1·3) Aortic aneurysm 34 (0·9) Current smoking 296 (7·5) Previous history of laparotomy 953 (24·3) Preoperative chemotherapy 259 (6·6) Thickness of subcutaneous fat based on CT (cm)† 1·7 (0·1–7·0) Primary disease for surgery Malignant 3742 (95·3) Benign 185 (4·7) Operative factors Operative status Elective 3778 (96·2) Emergency 149 (3·8) Surgical approach Open 3286 (83·7) Laparoscopically assisted 641 (16·3) Operative procedure Gastric resection 1085 (27·6) Colorectal resection 1920 (48·9) HPB resection 766 (19·5) Other 156 (4·0) Duration of surgery (min)† 196 (29–1552) Blood loss (ml)† 210 (0–17 125) Wound length (cm)† 17·5 (4–59·5) Intraoperative blood transfusion 367 (9·3) Wound classification I 58 (1·5) II 3690 (94·0) III 104 (2·6) IV 75 (1·9) Fascial closure Interrupted braid 2479 (63·1) Interrupted monofilament 922 (23·5) Continuous monofilament 443 (11·3) Continuous braid 83 (2·1) Type of incision Midline 3041 (77·4) Paramedian 313 (8·0) Transverse 176 (4·5) Inverted L type 322 (8·2) Mercedes type 75 (1·9) Postoperative factors All complications 1097 (27·9) Dindo–Clavien classification I 258 (6·6) II 379 (9·7) IIIa 424 (10·8) IIIb 20 (0·5) IVa 15 (0·5) IVb 1 (<0·1) Surgical-site infection 722 (18·4) Incisional 351 (8·9) Superficial 290 (7·4) Deep 61 (1·6) Organ/space 427 (10·8) Remote infection 210 (5·3) . . . No. of patients (n = 3927)* . Preoperative factors Age (years)† 69 (20–96) Sex ratio (M : F) 2506 : 1421 Body mass index (kg/m2)† 21·9 (13·1–42·3) ASA grade I 1662 (42·3) II 2089 (53·2) III 158 (4·0) IV 18 (0·5) Co-morbidity 2265 (57·7) Hypertension 1451 (36·9) Diabetes mellitus 739 (18·8) COPD 126 (3·2) Collagen disease 53 (1·3) Aortic aneurysm 34 (0·9) Current smoking 296 (7·5) Previous history of laparotomy 953 (24·3) Preoperative chemotherapy 259 (6·6) Thickness of subcutaneous fat based on CT (cm)† 1·7 (0·1–7·0) Primary disease for surgery Malignant 3742 (95·3) Benign 185 (4·7) Operative factors Operative status Elective 3778 (96·2) Emergency 149 (3·8) Surgical approach Open 3286 (83·7) Laparoscopically assisted 641 (16·3) Operative procedure Gastric resection 1085 (27·6) Colorectal resection 1920 (48·9) HPB resection 766 (19·5) Other 156 (4·0) Duration of surgery (min)† 196 (29–1552) Blood loss (ml)† 210 (0–17 125) Wound length (cm)† 17·5 (4–59·5) Intraoperative blood transfusion 367 (9·3) Wound classification I 58 (1·5) II 3690 (94·0) III 104 (2·6) IV 75 (1·9) Fascial closure Interrupted braid 2479 (63·1) Interrupted monofilament 922 (23·5) Continuous monofilament 443 (11·3) Continuous braid 83 (2·1) Type of incision Midline 3041 (77·4) Paramedian 313 (8·0) Transverse 176 (4·5) Inverted L type 322 (8·2) Mercedes type 75 (1·9) Postoperative factors All complications 1097 (27·9) Dindo–Clavien classification I 258 (6·6) II 379 (9·7) IIIa 424 (10·8) IIIb 20 (0·5) IVa 15 (0·5) IVb 1 (<0·1) Surgical-site infection 722 (18·4) Incisional 351 (8·9) Superficial 290 (7·4) Deep 61 (1·6) Organ/space 427 (10·8) Remote infection 210 (5·3) * With percentages in parentheses unless indicated otherwise; † values are median (range). ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease; CT, computed tomography; HPB, hepatopancreatobiliary. Open in new tab Table 1 Clinical characteristics . . . No. of patients (n = 3927)* . Preoperative factors Age (years)† 69 (20–96) Sex ratio (M : F) 2506 : 1421 Body mass index (kg/m2)† 21·9 (13·1–42·3) ASA grade I 1662 (42·3) II 2089 (53·2) III 158 (4·0) IV 18 (0·5) Co-morbidity 2265 (57·7) Hypertension 1451 (36·9) Diabetes mellitus 739 (18·8) COPD 126 (3·2) Collagen disease 53 (1·3) Aortic aneurysm 34 (0·9) Current smoking 296 (7·5) Previous history of laparotomy 953 (24·3) Preoperative chemotherapy 259 (6·6) Thickness of subcutaneous fat based on CT (cm)† 1·7 (0·1–7·0) Primary disease for surgery Malignant 3742 (95·3) Benign 185 (4·7) Operative factors Operative status Elective 3778 (96·2) Emergency 149 (3·8) Surgical approach Open 3286 (83·7) Laparoscopically assisted 641 (16·3) Operative procedure Gastric resection 1085 (27·6) Colorectal resection 1920 (48·9) HPB resection 766 (19·5) Other 156 (4·0) Duration of surgery (min)† 196 (29–1552) Blood loss (ml)† 210 (0–17 125) Wound length (cm)† 17·5 (4–59·5) Intraoperative blood transfusion 367 (9·3) Wound classification I 58 (1·5) II 3690 (94·0) III 104 (2·6) IV 75 (1·9) Fascial closure Interrupted braid 2479 (63·1) Interrupted monofilament 922 (23·5) Continuous monofilament 443 (11·3) Continuous braid 83 (2·1) Type of incision Midline 3041 (77·4) Paramedian 313 (8·0) Transverse 176 (4·5) Inverted L type 322 (8·2) Mercedes type 75 (1·9) Postoperative factors All complications 1097 (27·9) Dindo–Clavien classification I 258 (6·6) II 379 (9·7) IIIa 424 (10·8) IIIb 20 (0·5) IVa 15 (0·5) IVb 1 (<0·1) Surgical-site infection 722 (18·4) Incisional 351 (8·9) Superficial 290 (7·4) Deep 61 (1·6) Organ/space 427 (10·8) Remote infection 210 (5·3) . . . No. of patients (n = 3927)* . Preoperative factors Age (years)† 69 (20–96) Sex ratio (M : F) 2506 : 1421 Body mass index (kg/m2)† 21·9 (13·1–42·3) ASA grade I 1662 (42·3) II 2089 (53·2) III 158 (4·0) IV 18 (0·5) Co-morbidity 2265 (57·7) Hypertension 1451 (36·9) Diabetes mellitus 739 (18·8) COPD 126 (3·2) Collagen disease 53 (1·3) Aortic aneurysm 34 (0·9) Current smoking 296 (7·5) Previous history of laparotomy 953 (24·3) Preoperative chemotherapy 259 (6·6) Thickness of subcutaneous fat based on CT (cm)† 1·7 (0·1–7·0) Primary disease for surgery Malignant 3742 (95·3) Benign 185 (4·7) Operative factors Operative status Elective 3778 (96·2) Emergency 149 (3·8) Surgical approach Open 3286 (83·7) Laparoscopically assisted 641 (16·3) Operative procedure Gastric resection 1085 (27·6) Colorectal resection 1920 (48·9) HPB resection 766 (19·5) Other 156 (4·0) Duration of surgery (min)† 196 (29–1552) Blood loss (ml)† 210 (0–17 125) Wound length (cm)† 17·5 (4–59·5) Intraoperative blood transfusion 367 (9·3) Wound classification I 58 (1·5) II 3690 (94·0) III 104 (2·6) IV 75 (1·9) Fascial closure Interrupted braid 2479 (63·1) Interrupted monofilament 922 (23·5) Continuous monofilament 443 (11·3) Continuous braid 83 (2·1) Type of incision Midline 3041 (77·4) Paramedian 313 (8·0) Transverse 176 (4·5) Inverted L type 322 (8·2) Mercedes type 75 (1·9) Postoperative factors All complications 1097 (27·9) Dindo–Clavien classification I 258 (6·6) II 379 (9·7) IIIa 424 (10·8) IIIb 20 (0·5) IVa 15 (0·5) IVb 1 (<0·1) Surgical-site infection 722 (18·4) Incisional 351 (8·9) Superficial 290 (7·4) Deep 61 (1·6) Organ/space 427 (10·8) Remote infection 210 (5·3) * With percentages in parentheses unless indicated otherwise; † values are median (range). ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease; CT, computed tomography; HPB, hepatopancreatobiliary. Open in new tab The median length of follow-up for IH was 17 (range 1–37) months. Some 3316 (84·4 per cent) of the 3927 patients were followed for more than 12 months. Methods used to diagnose IH were physical examination in all patients, CT in 3250 (82·8 per cent) and ultrasound imaging in 572 (14·6 per cent). No imaging study was performed in 510 patients (13·0 per cent). In 233 patients who died more than 180 days after surgery, evaluation of IH was performed at least once before death. Some 318 patients were diagnosed with IH (Fig. 1); the Kaplan–Meier estimated incidence rates of IH were 5·2 per cent at 12 months and 10·3 per cent at 24 months (Fig. 1). Of 318 patients with IH, 21 (6·6 per cent) underwent hernia repair. Fig. 1 Open in new tabDownload slide Kaplan–Meier analysis of the rate of incisional hernia (IH) after abdominal surgery Univariable analysis Among 27 possible risk factors (including 14 preoperative, 10 operative and 3 postoperative factors), univariable analysis showed 16 factors to be associated with IH (Table 2): nine preoperative, six operative and one postoperative factor (I-SSI). Table 2 Univariable Cox regression analysis of risk factors for incisional hernia . . Hazard ratio . P . Preoperative factors Age (for every 10-year increase) 1·28 (1·15, 1·43) < 0·001 Sex ratio (M : F) 1·35 (1·08, 1·68) < 0·001 Body mass index (kg/m2) < 0·001 < 18·5 1·00 (reference) 18·5 to < 25 1·26 (0·85, 1·88) 0·245 25 to < 30 2·29 (1·50, 3·51) < 0·001 ≥ 30 2·81 (1·42, 5·52) 0·002 ASA grade (III/IV versus I/II) 1·67 (1·07, 2·61) 0·022 Hypertension 1·26 (1·01, 1·57) 0·042 Diabetes mellitus 1·34 (1·04, 1·74) 0·024 COPD 1·42 (0·83, 2·42) 0·199 Collagen disease 0·47 (0·11, 1·90) 0·294 Aortic aneurysm 0·85 (0·27, 2·67) 0·787 Current smoking 0·92 (0·60, 1·42) 0·728 Previous history of laparotomy 1·21 (0·94, 1·54) 0·125 Preoperative chemotherapy 1·46 (1·01, 2·14) 0·049 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·33 (1·18, 1·50) < 0·001 Primary disease for surgery (benign versus malignant) 1·33 (1·18, 1·50) < 0·001 Operative factors Operative status (emergency versus elective) 2·31 (1·54, 3·48) < 0·001 Wound classification (III/IV versus I/II) 2·29 (1·56, 3·36) < 0·001 Duration of surgery (for every 2-h increase) 1·00 (0·90, 1·10) 0·128 Blood loss (for every 500-ml increase) 1·04 (0·99, 1·11) 0·102 Intraoperative blood transfusion 1·59 (1·14, 2·21) 0·005 Surgical method (open versus laparoscopically assisted) 1·37 (0·98, 1·90) 0·059 Operative procedure < 0·001 Gastric resection 1·00 (reference) Colorectal resection 1·83 (1·36, 2·46) < 0·001 HPB resection 1·42 (0·98, 2·06) 0·059 Other 2·37 (1·41, 3·99) < 0·001 Wound length (for every 10-cm increase) 1·16 (1·03, 1·31) 0·013 Fascial closure 0·087 Continuous monofilament 1·00 (reference) Continuous braid 0·97 (0·43, 2·18) 0·950 Interrupted monofilament 1·39 (0·95, 2·05) 0·089 Interrupted braid 1·01 (0·71, 1·43) 0·950 Type of incision 0·026 Midline 1·00 (reference) Paramedian 0·68 (0·43, 1·07) 0·097 Transverse 0·45 (0·21, 0·97) 0·041 Inverted L type 0·60 (0·37, 0·98) 0·042 Mercedes type 0·57 (0·21, 1·53) 0·268 Postoperative factors Incisional SSI 1·95 (1·45, 2·64) < 0·001 Organ/space SSI 1·27 (0·91, 1·77) 0·157 Remote infection 1·40 (0·92, 2·15) 0·115 . . Hazard ratio . P . Preoperative factors Age (for every 10-year increase) 1·28 (1·15, 1·43) < 0·001 Sex ratio (M : F) 1·35 (1·08, 1·68) < 0·001 Body mass index (kg/m2) < 0·001 < 18·5 1·00 (reference) 18·5 to < 25 1·26 (0·85, 1·88) 0·245 25 to < 30 2·29 (1·50, 3·51) < 0·001 ≥ 30 2·81 (1·42, 5·52) 0·002 ASA grade (III/IV versus I/II) 1·67 (1·07, 2·61) 0·022 Hypertension 1·26 (1·01, 1·57) 0·042 Diabetes mellitus 1·34 (1·04, 1·74) 0·024 COPD 1·42 (0·83, 2·42) 0·199 Collagen disease 0·47 (0·11, 1·90) 0·294 Aortic aneurysm 0·85 (0·27, 2·67) 0·787 Current smoking 0·92 (0·60, 1·42) 0·728 Previous history of laparotomy 1·21 (0·94, 1·54) 0·125 Preoperative chemotherapy 1·46 (1·01, 2·14) 0·049 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·33 (1·18, 1·50) < 0·001 Primary disease for surgery (benign versus malignant) 1·33 (1·18, 1·50) < 0·001 Operative factors Operative status (emergency versus elective) 2·31 (1·54, 3·48) < 0·001 Wound classification (III/IV versus I/II) 2·29 (1·56, 3·36) < 0·001 Duration of surgery (for every 2-h increase) 1·00 (0·90, 1·10) 0·128 Blood loss (for every 500-ml increase) 1·04 (0·99, 1·11) 0·102 Intraoperative blood transfusion 1·59 (1·14, 2·21) 0·005 Surgical method (open versus laparoscopically assisted) 1·37 (0·98, 1·90) 0·059 Operative procedure < 0·001 Gastric resection 1·00 (reference) Colorectal resection 1·83 (1·36, 2·46) < 0·001 HPB resection 1·42 (0·98, 2·06) 0·059 Other 2·37 (1·41, 3·99) < 0·001 Wound length (for every 10-cm increase) 1·16 (1·03, 1·31) 0·013 Fascial closure 0·087 Continuous monofilament 1·00 (reference) Continuous braid 0·97 (0·43, 2·18) 0·950 Interrupted monofilament 1·39 (0·95, 2·05) 0·089 Interrupted braid 1·01 (0·71, 1·43) 0·950 Type of incision 0·026 Midline 1·00 (reference) Paramedian 0·68 (0·43, 1·07) 0·097 Transverse 0·45 (0·21, 0·97) 0·041 Inverted L type 0·60 (0·37, 0·98) 0·042 Mercedes type 0·57 (0·21, 1·53) 0·268 Postoperative factors Incisional SSI 1·95 (1·45, 2·64) < 0·001 Organ/space SSI 1·27 (0·91, 1·77) 0·157 Remote infection 1·40 (0·92, 2·15) 0·115 Values in parentheses are 95 per cent confidence intervals. ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease; CT, computed tomography; HPB, hepatopancreatobiliary; SSI, surgical-site infection. Open in new tab Table 2 Univariable Cox regression analysis of risk factors for incisional hernia . . Hazard ratio . P . Preoperative factors Age (for every 10-year increase) 1·28 (1·15, 1·43) < 0·001 Sex ratio (M : F) 1·35 (1·08, 1·68) < 0·001 Body mass index (kg/m2) < 0·001 < 18·5 1·00 (reference) 18·5 to < 25 1·26 (0·85, 1·88) 0·245 25 to < 30 2·29 (1·50, 3·51) < 0·001 ≥ 30 2·81 (1·42, 5·52) 0·002 ASA grade (III/IV versus I/II) 1·67 (1·07, 2·61) 0·022 Hypertension 1·26 (1·01, 1·57) 0·042 Diabetes mellitus 1·34 (1·04, 1·74) 0·024 COPD 1·42 (0·83, 2·42) 0·199 Collagen disease 0·47 (0·11, 1·90) 0·294 Aortic aneurysm 0·85 (0·27, 2·67) 0·787 Current smoking 0·92 (0·60, 1·42) 0·728 Previous history of laparotomy 1·21 (0·94, 1·54) 0·125 Preoperative chemotherapy 1·46 (1·01, 2·14) 0·049 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·33 (1·18, 1·50) < 0·001 Primary disease for surgery (benign versus malignant) 1·33 (1·18, 1·50) < 0·001 Operative factors Operative status (emergency versus elective) 2·31 (1·54, 3·48) < 0·001 Wound classification (III/IV versus I/II) 2·29 (1·56, 3·36) < 0·001 Duration of surgery (for every 2-h increase) 1·00 (0·90, 1·10) 0·128 Blood loss (for every 500-ml increase) 1·04 (0·99, 1·11) 0·102 Intraoperative blood transfusion 1·59 (1·14, 2·21) 0·005 Surgical method (open versus laparoscopically assisted) 1·37 (0·98, 1·90) 0·059 Operative procedure < 0·001 Gastric resection 1·00 (reference) Colorectal resection 1·83 (1·36, 2·46) < 0·001 HPB resection 1·42 (0·98, 2·06) 0·059 Other 2·37 (1·41, 3·99) < 0·001 Wound length (for every 10-cm increase) 1·16 (1·03, 1·31) 0·013 Fascial closure 0·087 Continuous monofilament 1·00 (reference) Continuous braid 0·97 (0·43, 2·18) 0·950 Interrupted monofilament 1·39 (0·95, 2·05) 0·089 Interrupted braid 1·01 (0·71, 1·43) 0·950 Type of incision 0·026 Midline 1·00 (reference) Paramedian 0·68 (0·43, 1·07) 0·097 Transverse 0·45 (0·21, 0·97) 0·041 Inverted L type 0·60 (0·37, 0·98) 0·042 Mercedes type 0·57 (0·21, 1·53) 0·268 Postoperative factors Incisional SSI 1·95 (1·45, 2·64) < 0·001 Organ/space SSI 1·27 (0·91, 1·77) 0·157 Remote infection 1·40 (0·92, 2·15) 0·115 . . Hazard ratio . P . Preoperative factors Age (for every 10-year increase) 1·28 (1·15, 1·43) < 0·001 Sex ratio (M : F) 1·35 (1·08, 1·68) < 0·001 Body mass index (kg/m2) < 0·001 < 18·5 1·00 (reference) 18·5 to < 25 1·26 (0·85, 1·88) 0·245 25 to < 30 2·29 (1·50, 3·51) < 0·001 ≥ 30 2·81 (1·42, 5·52) 0·002 ASA grade (III/IV versus I/II) 1·67 (1·07, 2·61) 0·022 Hypertension 1·26 (1·01, 1·57) 0·042 Diabetes mellitus 1·34 (1·04, 1·74) 0·024 COPD 1·42 (0·83, 2·42) 0·199 Collagen disease 0·47 (0·11, 1·90) 0·294 Aortic aneurysm 0·85 (0·27, 2·67) 0·787 Current smoking 0·92 (0·60, 1·42) 0·728 Previous history of laparotomy 1·21 (0·94, 1·54) 0·125 Preoperative chemotherapy 1·46 (1·01, 2·14) 0·049 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·33 (1·18, 1·50) < 0·001 Primary disease for surgery (benign versus malignant) 1·33 (1·18, 1·50) < 0·001 Operative factors Operative status (emergency versus elective) 2·31 (1·54, 3·48) < 0·001 Wound classification (III/IV versus I/II) 2·29 (1·56, 3·36) < 0·001 Duration of surgery (for every 2-h increase) 1·00 (0·90, 1·10) 0·128 Blood loss (for every 500-ml increase) 1·04 (0·99, 1·11) 0·102 Intraoperative blood transfusion 1·59 (1·14, 2·21) 0·005 Surgical method (open versus laparoscopically assisted) 1·37 (0·98, 1·90) 0·059 Operative procedure < 0·001 Gastric resection 1·00 (reference) Colorectal resection 1·83 (1·36, 2·46) < 0·001 HPB resection 1·42 (0·98, 2·06) 0·059 Other 2·37 (1·41, 3·99) < 0·001 Wound length (for every 10-cm increase) 1·16 (1·03, 1·31) 0·013 Fascial closure 0·087 Continuous monofilament 1·00 (reference) Continuous braid 0·97 (0·43, 2·18) 0·950 Interrupted monofilament 1·39 (0·95, 2·05) 0·089 Interrupted braid 1·01 (0·71, 1·43) 0·950 Type of incision 0·026 Midline 1·00 (reference) Paramedian 0·68 (0·43, 1·07) 0·097 Transverse 0·45 (0·21, 0·97) 0·041 Inverted L type 0·60 (0·37, 0·98) 0·042 Mercedes type 0·57 (0·21, 1·53) 0·268 Postoperative factors Incisional SSI 1·95 (1·45, 2·64) < 0·001 Organ/space SSI 1·27 (0·91, 1·77) 0·157 Remote infection 1·40 (0·92, 2·15) 0·115 Values in parentheses are 95 per cent confidence intervals. ASA, American Society of Anesthesiologists; COPD, chronic obstructive pulmonary disease; CT, computed tomography; HPB, hepatopancreatobiliary; SSI, surgical-site infection. Open in new tab Multivariable analysis All risk factors were included in the multivariable analysis using a Cox regression analysis. Nine independent risk factors for IH were identified (Table 3), including wound grade III/IV (HR 2·26), BMI 25 kg/m2 or higher (HR 1·76), midline incision (HR 1·74), postoperative I-SSI (HR 1·68), preoperative chemotherapy (HR 1·61), intraoperative blood transfusion (HR 1·46), greater age by 10-year increase (HR 1·30), female sex (HR 1·26) and the thickness of subcutaneous fat based on CT for every 1-cm increase (HR 1·18). Table 3 Multivariable Cox regression analysis of independent risk factors for incisional hernia . Hazard ratio . P . Age (for every 10-year increase) 1·30 (1·16, 1·45) < 0·001 Sex (F versus M) 1·26 (1·01, 1·59) 0·042 Body mass index (≥ 25 versus < 25 kg/m2) 1·76 (1·35, 2·30) < 0·001 Preoperative chemotherapy 1·61 (1·08, 2·37) 0·017 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·18 (1·03, 1·35) 0·017 Wound classification (III/IV versus I/II) 2·26 (1·52, 3·35) < 0·001 Intraoperative blood transfusion 1·46 (1·04, 2·05) 0·028 Type of incision (midline versus non-midline) 1·74 (1·28, 2·38) < 0·001 Incisional surgical-site infection 1·68 (1·24, 2·28) < 0·001 . Hazard ratio . P . Age (for every 10-year increase) 1·30 (1·16, 1·45) < 0·001 Sex (F versus M) 1·26 (1·01, 1·59) 0·042 Body mass index (≥ 25 versus < 25 kg/m2) 1·76 (1·35, 2·30) < 0·001 Preoperative chemotherapy 1·61 (1·08, 2·37) 0·017 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·18 (1·03, 1·35) 0·017 Wound classification (III/IV versus I/II) 2·26 (1·52, 3·35) < 0·001 Intraoperative blood transfusion 1·46 (1·04, 2·05) 0·028 Type of incision (midline versus non-midline) 1·74 (1·28, 2·38) < 0·001 Incisional surgical-site infection 1·68 (1·24, 2·28) < 0·001 Values in parentheses are 95 per cent confidence intervals. CT, computed tomography. Open in new tab Table 3 Multivariable Cox regression analysis of independent risk factors for incisional hernia . Hazard ratio . P . Age (for every 10-year increase) 1·30 (1·16, 1·45) < 0·001 Sex (F versus M) 1·26 (1·01, 1·59) 0·042 Body mass index (≥ 25 versus < 25 kg/m2) 1·76 (1·35, 2·30) < 0·001 Preoperative chemotherapy 1·61 (1·08, 2·37) 0·017 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·18 (1·03, 1·35) 0·017 Wound classification (III/IV versus I/II) 2·26 (1·52, 3·35) < 0·001 Intraoperative blood transfusion 1·46 (1·04, 2·05) 0·028 Type of incision (midline versus non-midline) 1·74 (1·28, 2·38) < 0·001 Incisional surgical-site infection 1·68 (1·24, 2·28) < 0·001 . Hazard ratio . P . Age (for every 10-year increase) 1·30 (1·16, 1·45) < 0·001 Sex (F versus M) 1·26 (1·01, 1·59) 0·042 Body mass index (≥ 25 versus < 25 kg/m2) 1·76 (1·35, 2·30) < 0·001 Preoperative chemotherapy 1·61 (1·08, 2·37) 0·017 Thickness of subcutaneous fat based on CT (for every 1-cm increase) 1·18 (1·03, 1·35) 0·017 Wound classification (III/IV versus I/II) 2·26 (1·52, 3·35) < 0·001 Intraoperative blood transfusion 1·46 (1·04, 2·05) 0·028 Type of incision (midline versus non-midline) 1·74 (1·28, 2·38) < 0·001 Incisional surgical-site infection 1·68 (1·24, 2·28) < 0·001 Values in parentheses are 95 per cent confidence intervals. CT, computed tomography. Open in new tab Impact of depth of incisional surgical-site infection When I-SSI was separated into SI-SSI and DI-SSI, the incidence of IH was significantly greater in patients with DI-SSI than in patients with SI-SSI (P = 0·001) (Fig. 2). The estimated IH incidence rates in patients without I-SSI, with SI-SSI and with DI-SSI were 4·6, 10·1 and 20 per cent respectively at 12 months, and 9·8, 14·3 and 24 per cent at 24 months. Compared with patients without I-SSI, the univariable Cox proportional hazards model for IH occurrence showed a HR of 1·71 (95 per cent c.i. 1·22 to 2·41; P = 0·002) for patients with SI-SSI and 3·32 (1·90 to 5·80; P < 0·001) for patients with DI-SSI. Fig. 2 Open in new tabDownload slide Kaplan–Meier analysis of incisional hernia (IH) in relation to depth of incisional surgical-site infection (I-SSI). DI-SSI, deep incisional surgical-site infection; SI-SSI, superficial incisional surgical-site infection. P = 0·001 (DI-SSIversusSI-SSI), P < 0·001 (DI-SSIversus no I-SSI) (log rank test) Discussion This observational study included approximately 4000 patients who were investigated for IH after abdominal surgery. IH incidence rates were 5·2 and 10·3 per cent after 12 and 24 months respectively. Independent perioperative risk factors identified for IH were wound classification (III/V), high BMI, midline incision, I-SSI, preoperative chemotherapy, intraoperative blood transfusion, older age, female sex and the thickness of subcutaneous fat measured by CT. Patients with DI-SSI had a higher incidence rate than the patients without I-SSI or those with SI-SSI. Although previous investigations have reported incidence rates and risk factors for IH, only a few studies were prospective and followed patients for a longer time period8–9,12,15–17. The present study included a large cohort of patients, approximately equal to the numbers reported in previous meta-analyses1,3, and used clear diagnostic criteria and follow-up for IH. The incidence rates of IH in this study at 12 and 24 months may represent the realistic rates of IH after abdominal surgery in the Japanese population. Several reports8,11,14,18–19,24 have shown that I-SSI is an important risk factor for IH. However, no large-scale report has differentiated between SI-SSI and DI-SSI as risk factors. In the present study, DI-SSI was clearly defined, and the results demonstrated that SI-SSI and DI-SSI had different impacts on the risk of IH. DI-SSI has a strong association with IH. I-SSI induces abnormal collagen metabolism, and inhibits and delays the fascial wound-healing process, especially in the proliferative phase1,10,32–35. DI-SSI may directly impair the early wound-healing process in fascia by inducing the wound dehiscence to drain pus with weakening of the healed wound. Optimal perioperative wound management is therefore recommended to reduce the incidence of I-SSI and minimize the incidence of IH27,36–37. The present study showed that BMI and the thickness of subcutaneous fat, as measured by CT, were independent risk factors for IH. Several studies12–13,18–20 have demonstrated high BMI to be a risk factor for IH. A previous Japanese study38 on I-SSI indicated that the thickness of subcutaneous fat, but not BMI, was an independent risk factor for I-SSI in elective colorectal surgery. The present study provides further evidence that thick subcutaneous fat is significantly associated with IH. For abdominal surgery in general, the type of incision is chosen according to the surgical philosophy and the surgeon's preference. A midline incision is used most commonly, because it allows easy access to the abdominal cavity. This study demonstrated that patients operated on with a midline incision had a higher incidence of IH than those who had a non-midline incision. In support, a recent meta-analysis39 found that the incidence of IH in patients with a midline incision was higher than that in patients with transverse and paramedian incisions. The exact mechanism for this difference in incidence is unknown. Preoperative chemotherapy and intraoperative blood transfusion are known to induce immunosuppression40,41, which may render patients susceptible to infection and impair the tissue-healing process20,42. Advanced age is also associated with delayed wound healing and decreased collagen synthesis11. A few Western reports11,18–19 have shown male sex to be an independent risk factor for IH. In contrast, a Korean series14 and the present study, indicated that female sex is a significant risk factor. These discrepancies may be due to different patient populations with different BMI, different lifestyles, and variations in gene expression related to the wound-healing process and collagen metabolism10,34,43. The standard for fascial closure is a continuous suture using absorbable monofilament1,3,19,25. However, an interrupted absorbable braid suture was used most commonly in the present study. Nevertheless, the results of this study suggested that the suture materials and methods had no significant impact on the incidence of IH. A major limitation of the present study was the length of follow-up. Although all patients were followed for at least 180 days, the optimal follow-up interval to determine the incidence of IH is controversial. Follow-up periods in previous studies12,16–17,19,23–24,31 were variable, ranging from 3 months to 3 years. A recent prospective study31 found that the incidence of IH increased in a time-dependent manner, and the authors concluded that 3 years of follow-up was mandatory when evaluating IH. Another long-term study15, which compared laparoscopic with open surgery for rectal cancer, demonstrated that incidence of IH plateaued within 3 years after surgery. In a retrospective Japanese study20 with a median follow-up of 52 months, 27 of 48 patients with IH were diagnosed within 9 months of operation, with only five patients being diagnosed after 12 months. Based on this study20, the minimum follow-up period in the present investigation was set to at least 180 days. Other limitations of the present study were that the collected data did not include some potentially important factors such as nutrition, co-morbidities, use of postoperative chemotherapy and radiotherapy, and tumour recurrence in patients with malignant disease. Other important factors not included were wound complications, such as wound dehiscence, seroma and haematoma, and the number, location and time-dependent growth rate of the abdominal defects. This study included only Japanese patients, and the Japanese population is known to differ from the Western population in a variety of aspects. Thus, it is uncertain whether the results of this study can be extrapolated to Western populations. This study found several risk factors for IH after abdominal surgery. I-SSI, especially DI-SSI, was strongly associated with the incidence of IH and is of importance because this complication is potentially preventable. Contributors The following investigators also participated in this study: A. Ishikawa (Department of Surgery, Chubu Rosai Hospital); A. Akutagawa (Nagoya Ekisaikai Hospital); A. Morioka, H. Matsuba and Y. Asaba (Kumiai Kosei Hospital); E. Takeuchi (Japanese Red Cross Nagoya Daiichi Hospital); H. Hasegawa and S. Komatsu (Japanese Red Cross Nagoya Daini Hospital); K. Shirai (Yamashita Hospital); M. Kato and A. Okajima (Kamiiida Daiichi General Hospital); M. Terasaki and K. Suzumura (Shizuoka Saiseikai General Hospital); M. Momiyama (Tokai Hospital); M. Kanai and K. Aizu (Kasugai Municipal Hospital); S. Kamiya (Tsushima City Hospital); S. Iyomasa, Y. Mokuno and H. 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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) © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd TI - Incidence of and risk factors for incisional hernia after abdominal surgery JF - British Journal of Surgery DO - 10.1002/bjs.9600 DA - 2014-09-08 UR - https://www.deepdyve.com/lp/oxford-university-press/incidence-of-and-risk-factors-for-incisional-hernia-after-abdominal-nENRLALYCc SP - 1439 EP - 1447 VL - 101 IS - 11 DP - DeepDyve ER -