Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial.

Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.

Infectious Complication in Relation to the Prophylactic Mesh Position: The PRIMA Trial Revisited.

BACKGROUND: Prophylactic mesh reinforcement has proven to reduce the incidence of incisional hernia (IH). Fear of infectious complications may withhold the widespread implementation of prophylactic mesh reinforcement, particularly in the onlay position. STUDY DESIGN: Patients scheduled for elective midline surgery were randomly assigned to a suture closure group, onlay mesh group, or sublay mesh group. The incidence, treatment, and outcomes of patients with infectious complications were assessed through examining the adverse event forms. Data were collected prospectively for 2 years after the index procedure. RESULTS: Overall, infectious complications occurred in 14/107 (13.3%) patients in the suture group and in 52/373 (13.9%) patients with prophylactic mesh reinforcement (p = 0.821). Infectious complications occurred in 17.6% of the onlay group and 10.3% of the sublay group (p = 0.042). Excluding anastomotic leakage as a cause, these incidences were 16% (onlay) and 9.7% (sublay), p = 0.073. The mesh could remain in-situ in 40/52 (77%) patients with an infectious complication. The 2-year IH incidence after onlay mesh reinforcement was 10 in 33 (30.3%) with infectious complications and 15 in 140 (9.7%) without infectious complications (p = 0.003). This difference was not statistically significant for the sublay group. CONCLUSIONS: Prophylactic mesh placement was not associated with increased incidence, severity, or need for invasive treatment of infectious complications compared with suture closure. Patients with onlay mesh reinforcement and an infectious complication had a significantly higher risk of developing an incisional hernia, compared with those in the sublay group.

Repair of complex abdominal wall hernias with a cross-linked porcine acellular matrix: cross-sectional results of a Dutch cohort study.

BACKGROUND: The use of synthetic mesh in potentially contaminated and contaminated incisional hernias may lead to a higher morbidity and mortality. Biological meshes may provide a solution, but since these meshes are rarely used, little is known about long-term results. The aim of this cohort study was to evaluate the long-term clinical efficacy and patient satisfaction following Permacol™ in complex abdominal wall hernia repair (CAWHR) patients in a cross-sectional fashion. MATERIALS AND METHODS: All patients were operated for CAWHR with Permacol™ in the Netherlands between 2009 and 2012. The design was a multicenter cross-sectional cohort study. The STROCSS statement was followed. Patients were interviewed, underwent abdominal examination, and completed quality-of-life questionnaires. ClinicalTrials.gov Identifier NCT02166112. Research Registry Identifier researchregistry4713. RESULTS: Seventy-seven patients were seen in the outpatient clinic. Their hernias were classified as potentially contaminated in 25 patients (32.5%) and infected in 52 patients (67.5%). The mean follow-up was 22.2 ±â€¯12.6 months. The most frequent postoperative complication was wound infection (n = 21; 27.3%), meshes had to be removed in five patients (6.5%). By the time of their visit to the outpatient clinic, 22 patients (28.6%) had a recurrence of whom ten (13%) had undergone reoperation. Thirty-nine patients (50.6%) had bulging of the abdominal wall. Quality-of-life questionnaires revealed that patients graded their health status with a mean 6.8 (± 1.8) out of 10 points. CONCLUSION: Bulging and recurrence are frequently observed in patients treated with Permacol™ for CAWHR. Considering both recurrence and bulging as undesirable outcomes of treatment, a total of 46 patients (59.7%) had an unfavorable outcome. Infection rates were high, but comparable with similar patient cohorts. Quality-of-life questionnaires revealed that patients were satisfied with their general health, but scored significantly lower on most quality-of-life modalities of the Short Form-36 questionnaire.

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial.

BACKGROUND: Incisional hernia is a frequent long-term complication after abdominal surgery, with a prevalence greater than 30% in high-risk groups. The aim of the PRIMA trial was to evaluate the effectiveness of mesh reinforcement in high-risk patients, to prevent incisional hernia. METHODS: We did a multicentre, double-blind, randomised controlled trial at 11 hospitals in Austria, Germany, and the Netherlands. We included patients aged 18 years or older who were undergoing elective midline laparotomy and had either an abdominal aortic aneurysm or a body-mass index (BMI) of 27 kg/m2 or higher. We randomly assigned participants using a computer-generated randomisation sequence to one of three treatment groups: primary suture; onlay mesh reinforcement; or sublay mesh reinforcement. The primary endpoint was incidence of incisional hernia during 2 years of follow-up, analysed by intention to treat. Adjusted odds ratios (ORs) were estimated by logistic regression. This trial is registered at ClinicalTrials.gov, number NCT00761475. FINDINGS: Between March, 2009, and December, 2012, 498 patients were enrolled to the study, of whom 18 were excluded before randomisation. Therefore, we included 480 patients in the primary analysis: 107 were assigned primary suture only, 188 were allocated onlay mesh reinforcement, and 185 were assigned sublay mesh reinforcement. 92 patients were identified with an incisional hernia, 33 (30%) who were allocated primary suture only, 25 (13%) who were assigned onlay mesh reinforcement, and 34 (18%) who were assigned sublay mesh reinforcement (onlay mesh reinforcement vs primary suture, OR 0·37, 95% CI 0·20-0·69; p=0·0016; sublay mesh reinforcement vs primary suture, 0·55, 0·30-1·00; p=0·05). Seromas were more frequent in patients allocated onlay mesh reinforcement (34 of 188) than in those assigned primary suture (five of 107; p=0·002) or sublay mesh reinforcement (13 of 185; p=0·002). The incidence of wound infection did not differ between treatment groups (14 of 107 primary suture; 25 of 188 onlay mesh reinforcement; and 19 of 185 sublay mesh reinforcement). INTERPRETATION: A significant reduction in incidence of incisional hernia was achieved with onlay mesh reinforcement compared with sublay mesh reinforcement and primary suture only. Onlay mesh reinforcement has the potential to become the standard treatment for high-risk patients undergoing midline laparotomy. FUNDING: Baxter; B Braun Surgical SA.

Parastomal Hernia: Impact on Quality of Life?

INTRODUCTION: Parastomal hernia (PH) is a frequent complication after end-colostomy formation. PH may negatively influence the quality of life in end-colostomy patients. Our study investigates the quality of life and body image (BI) in patients with an end-colostomy. METHODS: We conducted a cross-sectional study of end-colostomy patients in two different hospitals. Patients were included if they had received a Hartmann procedure or abdominal perineal resection between 2004 and 2011. Patients were invited to the outpatient clinic for clinical examination to determine if a PH was present and were asked to fill out the Short form 36, EuroQol-5D, and body image questionnaire (BIQ). RESULTS: One-hundred-and-fifty patients were eligible for the study; 139 filled out the questionnaires, of which 79 (56.8 %) had developed a PH. A linear multivariate regression showed PH caused a decrease in physical functioning (difference -10.2, p = 0.033) and general health (difference -9.0, p = 0.021), increase in pain (difference -11.3, p = 0.009) and decrease in the overall physical component score (difference -4.8, p = 0.020). The BIQ showed that PH increased the shame of the scar (difference -0.4, p = 0.010). Having an incisional hernia simultaneously decreased patients' scoring of the scar in the BIQ (difference -0.99, p = 0.015). DISCUSSION: PHs cause significant decreases in quality of life and BI of patients. Counseling of patients towards PH and prevention of PH should therefore be of more concern in surgical departments.

Risk factors for inguinal hernia in middle-aged and elderly men: results from the Rotterdam Study.

BACKGROUND: Prospective data on risk factors and the incidence of inguinal hernia are sparse, especially in an elderly population. The aim of this study was to determine the incidence of and risk factors for inguinal hernia. METHODS: We analyzed data from the Rotterdam Study, a prospective cohort study that observed the general population aged ≥45 years of Ommoord, a district in Rotterdam, from baseline (1990) over a period of >20 years. Diagnoses of inguinal hernia were obtained from hospital discharge records and records from general practitioners. Multivariate regression analysis was performed to determine risk factors for inguinal hernia development. RESULTS: Among 5,780 men, with a total of 50,802 person-years, who did not have a hernia at baseline, 416 cases of inguinal hernia (7.2%) occurred. The 20-year cumulative incidence was 14%. Age-adjusted hazard ratio (HR) for inguinal hernia for men relative to women was 12.4 (95% CI, 9.5-16.3; P < .001). On multivariate analysis, the risk of inguinal hernia increased with advancing age (HR per 1-year increase in age, 1.03; 95% CI, 1.02-1.04; P < .001). Participants with a body mass index (BMI) of 25-30 kg/m2 had an HR of 0.72 (95% CI, 0.58-0.89; P = .003) compared with a BMI of <25; a BMI of >30 had an associated HR of 0.63 (95% CI, 0.42-0.94; P = .025). CONCLUSION: Inguinal hernia is common in the middle-aged and elderly male population and its incidence increases with advancing age. Overweight or obese patients have a lesser risk of developing an inguinal hernia.

Watchful waiting in incisional hernia: is it safe?

BACKGROUND: Incisional hernia (IH) is among the most common postoperative complications after abdominal surgery. Operative treatment (OT) using mesh is the treatment of choice. A strategy of watchful waiting (WW) might be a considered in some patients. This retrospective study compares the outcomes of WW and OT. METHODS: All patients presenting with IH in an academic surgery department between January 2004 and December 2009 were analyzed according to whether they were treated by WW or OT. Crossovers between both groups were also analyzed. Patient characteristics, information about the initial abdominal operative procedure, symptoms at presentation, and characteristics of the hernia were collected retrospectively. In case of OT, postoperative complications were analyzed. RESULT: In total, 255 patients were included; 151 (59%) in the OT group and 104 (41%) in WW group. The median follow-up was 68 months (interquartile range [IQR], 52-93). The reasons for WW were the absence of symptoms in 34 patients (33%), comorbidities in 24 (23%), and obesity in 23 (22%). During follow-up, 34 patients (33%) crossed over from WW to OT. Eight of the crossovers (24%) were emergency repairs owing to incarceration at a median of 1 month (IQR, 1-5) after the start of WW. The incidence of unexpected intraoperative intestinal perforation was greater in the crossover group (13%) compared with the OT group (2%; P = .002). Postoperative fistulas were seen in 7% of patients who crossed over from WW to OT versus 0% in primary OT (P = .002). Postoperatively, 3 patients died, 2 of whom were treated operatively after belonging initially to the WW group. CONCLUSION: WW for IH leads to high crossover rates with significantly greater incidence of intraoperative perforations, fistulas, and mortality, than in the OT group, particularly in patients who require emergency repair of IH owing to incarceration.

Short-term results of a randomized controlled trial comparing primary suture with primary glued mesh augmentation to prevent incisional hernia.

BACKGROUND: Incisional hernia is one of the most frequent postoperative complications after abdominal surgery. Patients with an abdominal aortic aneurysm and patients with a body mass index of 27 or higher have an increased risk to develop incisional hernia. Primary mesh augmentation is a method in which the abdominal wall is strengthened to reduce incisional hernia incidence. This study focused on the short-term results of the PRImary Mesh Closure of Abdominal Midline Wounds trial, a multicenter double blind randomized controlled trial. METHODS: Between 2009 and 2012 patients were included if they were operated via midline laparotomy, and had an abdominal aortic aneurysm or a body mass index of 27 or higher. Patients were randomly assigned to either receive primary suture, onlay mesh augmentation (OMA), or sublay mesh augmentation. RESULTS: Outcomes represent results after 1-month follow-up. A total of 480 patients were randomized. During analysis, significantly (P = 0.002) more seromas were detected after OMA (n = 34, 18.1%) compared with primary suture (n = 5, 4.7%) and sublay mesh augmentation (n = 13, 7%). No differences were discovered in any of the other outcomes such as surgical site infection, hematoma, reintervention, or readmission. Multivariable analysis revealed an increase in seroma formation after OMA with an odds ratio of 4.3 (P = 0.004) compared with primary suture and an odds ratio of 2.9 (P = 0.003) compared with sublay mesh augmentation. CONCLUSIONS: On the basis of these short-term results, primary mesh augmentation can be considered a safe procedure with only an increase in seroma formation after OMA, but without an increased risk of surgical site infection.

Abdominal rectus muscle atrophy and midline shift after colostomy creation.

INTRODUCTION: Incisional hernia (IH) can be attributed to multiple factors. The presence of a parastomal hernia has shown to be a risk factor for IH after midline laparotomy. Our hypothesis is that this increased risk of IH may be caused by changes in biomechanical forces, such as midline shift to the contralateral side of the colostomy owing to decreased restraining forces at the site of the colostomy, and left abdominal rectus muscle (ARM) atrophy owing to intercostal nerve damage. METHODS: Patients were selected if they underwent end-colostomy via open operation between 2004 and 2011. Patients were eligible if computed tomography (CT) had been performed postoperatively. If available, preoperative CTs were collected for case-control analyses. Midline shift was measured using V-scope application in the I-space, a CAVE-like virtual reality system. For the ARM atrophy hypothesis, measurements of ARM were performed at the level of colostomy, and 3 and 8 cm cranial and caudal of the colostomy. RESULTS: Postoperative CT were available for 77 patients; of these patients, 30 also had a preoperative CT. Median follow-up was 19 months. A mean shift to the right side was identified after preoperative and postoperative comparison; from -1.3 ± 4.6 to 2.1 ± 9.3 (P = .043). Furthermore, during rectus muscle measurements, a thinner left ARM was observed below the level of colostomy. DISCUSSION: Creation of a colostomy alters the abdominal wall. Atrophy of the left ARM was seen caudal to the level of the colostomy, and a midline shift to the right side was evident on CT. These changes may explain the increased rate of IH after colostomy creation.

Parastomal hernia is an independent risk factor for incisional hernia in patients with end colostomy.

BACKGROUND: Incisional hernia (IH) is the most frequent complication after abdominal operation, with an incidence of 11-20% and up to 35% in risk groups. Known risk groups for IH are abdominal aortic aneurysm and obesity. Our hypothesis is that parastomal hernia (PH) might also represent a risk factor for developing IH. Identifying risk factors can help determine the need for preventive measures such as primary mesh augmentation. METHODS: In a multicenter cross-sectional study, all patients who were operated between 2002 and 2010 by means of a Hartmann procedure or abdominoperineal resection were invited for a follow-up visit to our outpatient clinic. Primary outcome measures were the prevalence of IH and PH. All possible risk factors for IH were scored. A physical examination was performed and, when available, computed tomography was scored for IH and PH. RESULTS: A total of 150 patients were seen in the outpatient clinic. The median follow-up was 49 months (range, 30-75). IH had a prevalence of 37.1%, and PH had a prevalence of 52.3% during physical examination. On CT the prevalence was even greater, ie, 48.3% and 52.9%. IH and PH were both present in the same patient in 30% of all examined and in 35.6% after CT examination. PH was found to be a risk factor for IH on univariate and multivariate logistic regression analyses of variance, with an odds ratio of 7.2 (95% confidence interval 3.3-15.7). In addition, an emergency operation was found to be a risk factor for IH with an odds ratio of 5.8 in the multivariate analyses. CONCLUSION: Patients with a PH have a 7 times greater chance of developing an IH compared to patients without PH.

Meta-analysis of sublay versus onlay mesh repair in incisional hernia surgery.

BACKGROUND: Incisional hernia (IH) remains a very frequent postoperative complication. The 2 techniques most frequently used are the onlay repair and sublay repair. However, it remains unclear which technique is superior. DATA SOURCES: A meta-analysis was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The quality of the nonrandomized studies was assessed using the Newcastle-Ottawa Scale. RESULTS: Of 178 articles, 10 articles (2 randomized controlled trials, 1 prospective study, and 7 retrospective studies) comprising a total of 1,948 patients (775 onlay operations and 1173 sublay operations) were selected. Two of the studies scored below 5 points on the Newcastle-Ottawa Scale and were not selected. A trend was observed for IH recurrence in favor of sublay repair (odds ratio = 2.41; 95% confidence interval, .99 to 5.88; I(2) = 70%; P = .05). Surgical site infection occurred significantly less after sublay repair (odds ratio = 2.42; 95% confidence interval, 1.02 to 5.74; I(2) = 16%; P = .05). No difference was observed regarding seroma and hematoma. CONCLUSIONS: Although the majority of the included studies were retrospective studies, sublay repair seems the preferred technique for IH repair.

Meta-analysis of primary mesh augmentation as prophylactic measure to prevent incisional hernia.

BACKGROUND: Incisional hernia (IH) remains one of the most frequent postoperative complications after abdominal surgery. As a consequence, primary mesh augmentation (PMA), a technique to strengthen the abdominal wall, has been gaining popularity. This meta-analysis was conducted to evaluate the prophylactic effect of PMA on the incidence of IH compared to primary suture (PS). METHODS: A meta-analysis was conducted according to the PRISMA guidelines. Randomized controlled trials (RCTs) comparing PMA and PS for closing the abdominal wall after surgery were included. RESULTS: Out of 576 papers, 5 RCTs were selected comprising 346 patients. IH occurred significantly less in the PMA group (RR 0.25, 95% CI 0.12-0.52, I(2)0%; p < 0.001). No difference could be observed with regard to wound infection (RR 0.86, 95% CI 0.39-1.91, I(2) 0%; p = 0.71) or seroma (RR 1.22, 95% CI 0.64-2.33, I(2) 0%; p = 0.55). A trend was observed for chronic pain in favor of the PS group (RR 5.95, 95% CI 0.74-48.03, I(2)0%; p = 0.09). CONCLUSION: The use of PMA for abdominal wall closure is associated with significantly lower incidence of IH compared to PS.

Tissue adhesives in gastrointestinal anastomosis: a systematic review.

BACKGROUND: Anastomotic leakage in gastrointestinal (GI) surgery remains a major problem. Although numerous studies have been undertaken on the role of tissue adhesives as GI anastomotic sealants, no clear overview has been presented. This systematic review aims to provide a clear overview of recent experimental and clinical research on the sealing of different levels of GI anastomosis with tissue adhesives. METHODS: We searched MEDLINE and Embase databases for clinical and experimental articles published after 2000. We included articles only if these addressed a tissue adhesive applied around a GI anastomosis to prevent anastomotic leakage or decrease leakage-related complications. We categorized results according to level of anastomosis, category of tissue adhesive, and level of evidence. RESULTS: We included 48 studies: three on esophageal anastomosis, 13 on gastric anastomosis, four on pancreatic anastomosis, eight on small intestinal anastomosis, and 20 on colorectal anastomosis; 15 of the studies were on humans. CONCLUSIONS: Research on ileal and gastric/bariatric anastomosis reveals promising results for fibrin glue sealing for specific clinical indications. Sealing of pancreatico-enteric anastomosis does not seem to be useful for high-risk patients; however, research in this field is limited. Ileal anastomotic sealing was promising in every included study, and calls for clinical evaluation. For colorectal anastomoses, sealing with fibrin glue sealing seems to have more positive results than with cyanoacrylate. Further research should concentrate on the clinical evaluation of promising experimental results as well as on new types of tissue adhesives. This research field would benefit from a systematic experimental approach with comparable methodology.

A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence.

BACKGROUND: Incisional hernia is the most frequently seen long term complication after laparotomy causing much morbidity and even mortality. The overall incidence remains 11-20%, despite studies attempting to optimize closing techniques. Two patient groups, patients with abdominal aortic aneurysm and obese patients, have a risk for incisional hernia after laparotomy of more than 30%. These patients might benefit from mesh augmented midline closure as a means to reduce incisional hernia incidence. METHODS/DESIGN: The PRImary Mesh Closure of Abdominal Midline Wound (PRIMA) trial is a double-blinded international multicenter randomized controlled trial comparing running slowly absorbable suture closure with the same closure augmented with a sublay or onlay mesh. Primary endpoint will be incisional hernia incidence 2 years postoperatively. Secondary outcomes will be postoperative complications, pain, quality of life and cost effectiveness.A total of 460 patients will be included in three arms of the study and randomized between running suture closure, onlay mesh closure or sublay mesh closure. Follow-up will be at 1, 3, 12 and 24 months with ultrasound imaging performed at 6 and 24 months to objectify the presence of incisional hernia. Patients, investigators and radiologists will be blinded throughout the whole follow up. DISCCUSION: The use of prosthetic mesh has proven effective and safe in incisional hernia surgery however its use in a prophylactic manner has yet to be properly investigated. The PRIMA trial will provide level 1b evidence whether mesh augmented midline abdominal closure reduces incisional hernia incidence in high risk groups. TRIAL REGISTRATION: Clinical trial.gov NCT00761475.

Roux-en-Y gastric bypass as revisional procedure after gastric banding: leaving the band in place.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) and laparoscopic adjustable gastric banding (LAGB) are frequently used bariatric procedures. With both techniques, LAGB more than RYGB, failures occur. After years of experience with both techniques, we present a series of patients who underwent RYGB after failed LAGB. The band was kept in place. Our objective was to evaluate the safety and short-term effectiveness of RYGB after failed LAGB, without removing the band. The setting was a large teaching hospital in Heerlen, The Netherlands. METHODS: We first retrospectively considered the efficacy and complication rate of adding an adjustable band to RYGB. This was safe and effective. The patients lost a median of 7.6 kg within a median period of 21 months. The complication rate was low. Observing the positive results in this group, we began to leave the band in place when converting patients from LAGB to RYGB. RESULTS: A total of 12 patients underwent revision of LAGB to RYGB. There was no mortality. The complication rate and severity were low. During a median period of 16 months, the patients lost a median of 23 kg or 8 points in the body mass index. Also, additional improvement in co-morbidities was observed. CONCLUSION: Our results suggest that performing RYGB after LAGB and leaving the band in place is feasible, safe, and effective in the short term.