Prophylactic Mesh Placement During Formation of an End-colostomy: Long-term Randomized Controlled Trial on Effectiveness and Safety.

OBJECTIVE: The aim of this study was to determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term. BACKGROUND: A PSH is the most frequent complication after stoma formation. Prophylactic placement of a mesh has been suggested to prevent PSH, but long-term evidence to support this approach is scarce. METHODS: In this multicentre superiority trial patients undergoing the formation of a permanent colostomy were randomly assigned to either retromuscular polypropylene mesh reinforcement or conventional colostomy formation. Primary endpoint was the incidence of a PSH after 5 years. Secondary endpoints were morbidity, mortality, quality of life, and cost-effectiveness. RESULTS: A total of 150 patients were randomly assigned to the mesh group (n = 72) or nonmesh group (n = 78). For the long-term follow-up, 113 patients were analyzed, and 37 patients were lost to follow-up. After a median follow-up of 60 months (interquartile range: 48.6-64.4), 49 patients developed a PSH, 20 (27.8%) in the mesh group and 29 (37.2%) in the nonmesh group ( P = 0.22; RD: -9.4%; 95% CI: -24, 5.5). The cost related to the meshing strategy was € 2.239 lower than the nonmesh strategy (95% CI: 491.18, 3985.49), and quality-adjusted life years did not differ significantly between groups ( P = 0.959; 95% CI: -0.066, 0.070). CONCLUSIONS: Prophylactic mesh placement during the formation of an end-colostomy is a safe procedure but does not reduce the incidence of PSH after 5 years of follow-up. It does, however, delay the onset of PSH without a significant difference in morbidity, mortality, or quality of life, and seems to be cost-effective.

Heavyweight Mesh Is Superior to Lightweight Mesh in Laparo-endoscopic Inguinal Hernia Repair: A Meta-analysis and Trial Sequential Analysis of Randomized Controlled Trials.

OBJECTIVE: This meta-analysis and trial sequential analysis aims to provide an update on the available randomized controlled trials (RCTs) and recommendations on using lightweight mesh (LWM) or heavyweight mesh (HWM) in laparo-endoscopic inguinal hernia repair. BACKGROUND: LWM might reduce chronic pain through improved mesh flexibility and less fibrosis formation. However, in laparo-endoscopic repair chronic pain is already rare and LWM raise concerns of higher recurrence rates. METHODS: A literature search was conducted in May 2019 in MEDLINE, Embase, and the Cochrane library for RCTs that compared lightweight (≤50 g/m2) and heavyweight (>70 g/m2) mesh in patients undergoing laparo-endoscopic surgery for uncomplicated inguinal hernias. Outcomes were recurrences, chronic pain, and foreign-body sensation. The level of evidence was assessed using GRADE. Risk ratios (RR) and 95% confidence intervals (CI) were calculated by random effect meta-analyses. Trial-sequential-analyses were subsequently performed. RESULTS: Twelve RCTs, encompassing 2909 patients (LWM 1490 vs HWM 1419), were included. The follow-up range was 3 to 60 months. Using LWM increased the recurrence risk (LWM 32/1571, HWM 13/1508; RR 2.21; CI 1.14-4.31), especially in nonfixated mesh direct repairs (LWM 13/180, HWM 1/171; RR 7.27; CI 1.33-39.73) and/or large hernia defects. No difference was determined regarding any pain (LWM 123/1362, HWM 127/1277; RR 0.79; CI 0.52-1.20), severe pain (LWM 3/1226, HWM 9/1079; RR 0.38; CI 0.11-1.35), and foreign-body sensation (LWM 100/1074, HWM 103/913; RR 0.94; CI 0.73-1.20). CONCLUSION: HWM should be used in laparo-endoscopic repairs of direct or large inguinal hernias to reduce recurrence rates. LWM provide no benefit in indirect hernias.

Prophylactic Mesh Placement During Formation of an End-colostomy Reduces the Rate of Parastomal Hernia: Short-term Results of the Dutch PREVENT-trial.

OBJECTIVE: The aim of this study was to investigate the incidence of parastomal hernias (PSHs) after end-colostomy formation using a polypropylene mesh in a randomized controlled trial versus conventional colostomy formation. BACKGROUND: A PSH is the most frequent complication after stoma formation. Symptoms may range from mild abdominal pain to life-threatening obstruction and strangulation. The treatment of a PSH is notoriously difficult and recurrences up to 20% have been reported despite the use of mesh. This has moved surgical focus toward prevention. METHODS: Augmentation of the abdominal wall with a retro-muscular lightweight polypropylene mesh was compared with the traditional formation of a colostomy. In total, 150 patients (1:1 ratio) were included. The incidence of a PSH, morbidity, mortality, quality of life, and cost-effectiveness was measured after 1 year of follow-up. RESULTS: There was no difference between groups regarding demographics and predisposing factors for PSH. Three out of 67 patients (4.5%) in the mesh group and 16 out of 66 patients (24.2%) in the nonmesh group developed a PSH (P = 0.0011). No statistically significant difference was found in infections, concomitant hernias, SF-36 questionnaire, Von Korff pain score, and cost-effectiveness between both study groups. CONCLUSION: Prophylactic augmentation of the abdominal wall with a retromuscular lightweight polypropylene mesh at the ostomy site significantly reduces the incidence of PSH without a significant difference in morbidity, mortality, quality of life, or cost-effectiveness.

Long-Term Brain Structure and Cognition Following Bariatric Surgery.

Importance: Weight loss induced by bariatric surgery (BS) is associated with improved cognition and changed brain structure; however, previous studies on the association have used small cohorts and short follow-up periods, making it difficult to determine long-term neurological outcomes associated with BS. Objective: To investigate long-term associations of weight loss after BS with cognition and brain structure and perfusion. Design, Setting, and Participants: This cohort study included participants from the Bariatric Surgery Rijnstate and Radboudumc Neuroimaging and Cognition in Obesity study. Data from participants with severe obesity (body mass index [BMI; calculated as weight in kilograms divided by height in meters squared] >40, or BMI >35 with comorbidities) eligible for Roux-en-Y gastric bypass and aged 35 to 55 years were enrolled from a hospital specialized in BS (Rijnstate Hospital, Arnhem, the Netherlands). Participants were recruited between September 2018 and December 2020 with follow-up till March 2023. Data were collected before BS and at 6 and 24 months after BS. Data were analyzed from March to November 2023. Exposure: Roux-en-Y gastric bypass. Main Outcomes and Measures: Primary outcomes included body weight, BMI, waist circumference, blood pressure, medication use, cognitive performance (20% change index of compound z-score), brain volumes, cortical thickness, cerebral blood flow (CBF), and spatial coefficient of variation (sCOV). Secondary outcomes include cytokines, adipokines, depressive symptoms (assessed using the Beck Depression Inventory), and physical activity (assessed using the Baecke Questionnaire). Results: A total of 133 participants (mean [SD] age, 46.8 [5.7] years; 112 [84.2%] female) were included. Global cognition was at least 20% higher in 52 participants (42.9%) at 24 months after BS. Compared with baseline, at 24 months, inflammatory markers were lower (mean [SD] high-sensitivity C-reactive protein: 4.77 [5.80] µg/mL vs 0.80 [1.09] µg/mL; P < .001), fewer patients used antihypertensives (48 patients [36.1%] vs 22 patients [16.7%]), and patients had lower depressive symptoms (median [IQR] BDI score: 9.0 [5.0-13.0] vs 3.0 [1.0-6.0]; P < .001) and greater physical activity (mean [SD] Baecke score: 7.64 [1.29] vs 8.19 [1.35]; P < .001). After BS, brain structure and perfusion were lower in most brain regions, while hippocampal and white matter volume remained stable. CBF and sCOV did not change in nucleus accumbens and parietal cortex. The temporal cortex showed a greater thickness (mean [SD] thickness: 2.724 [0.101] mm vs 2.761 [0.007] mm; P = .007) and lower sCOV (median [IQR] sCOV: 4.41% [3.83%-5.18%] vs 3.97% [3.71%-4.59%]; P = .02) after BS. Conclusions and Relevance: These findings suggest that BS was associated with health benefits 2 years after surgery. BS was associated with improved cognition and general health and changed blood vessel efficiency and cortical thickness of the temporal cortex. These results may improve treatment options for patients with obesity and dementia.

Update of the international HerniaSurge guidelines for groin hernia management.

BACKGROUND: Groin hernia repair is one of the most common operations performed globally, with more than 20 million procedures per year. The last guidelines on groin hernia management were published in 2018 by the HerniaSurge Group. The aim of this project was to assess new evidence and update the guidelines. The guideline is intended for general and abdominal wall surgeons treating adult patients with groin hernias. METHOD: A working group of 30 international groin hernia experts and all involved stakeholders was formed and examined all new literature on groin hernia management, available until April 2022. Articles were screened for eligibility and assessed according to GRADE methodologies. New evidence was included, and chapters were rewritten. Statements and recommendations were updated or newly formulated as necessary. RESULTS: Ten chapters of the original HerniaSurge inguinal hernia guidelines were updated. In total, 39 new statements and 32 recommendations were formulated (16 strong recommendations). A modified Delphi method was used to reach consensus on all statements and recommendations among the groin hernia experts and at the European Hernia Society meeting in Manchester on October 21, 2022. CONCLUSION: The HerniaSurge Collaboration has updated the international guidelines for groin hernia management. The updated guidelines provide an overview of the best available evidence on groin hernia management and include evidence-based statements and recommendations for daily practice. Future guideline development will change according to emerging guideline methodology.

The CARTS study: Chemoradiation therapy for rectal cancer in the distal rectum followed by organ-sparing transanal endoscopic microsurgery.

BACKGROUND: The CARTS study is a multicenter feasibility study, investigating the role of rectum saving surgery for distal rectal cancer. METHODS/DESIGN: Patients with a clinical T1-3 N0 M0 rectal adenocarcinoma below 10 cm from the anal verge will receive neoadjuvant chemoradiation therapy (25 fractions of 2 Gy with concurrent capecitabine). Transanal Endoscopic Microsurgery (TEM) will be performed 8 - 10 weeks after the end of the preoperative treatment depending on the clinical response.Primary objective is to determine the number of patients with a (near) complete pathological response after chemoradiation therapy and TEM. Secondary objectives are the local recurrence rate and quality of life after this combined therapeutic modality. A three-step analysis will be performed after 20, 33 and 55 patients to ensure the feasibility of this treatment protocol. DISCUSSION: The CARTS-study is one of the first prospective multicentre trials to investigate the role of a rectum saving treatment modality using chemoradiation therapy and local excision. The CARTS study is registered at clinicaltrials.gov (NCT01273051).

Efficacy and Safety of 100 Laparoscopy-Assisted Transgastric Endoscopic Retrograde Cholangiopancreatography Procedures in Patients with Roux-en-Y Gastric Bypass.

PURPOSE: Laparoscopy-assisted transgastric endoscopic retrograde cholangiopancreatography (LAERCP) is an alternative for the anatomically challenging conventional ERCP in patients with a Roux-en-Y gastric bypass (RYGB) as it allows access to the biliary tree via the gastric remnant. We investigated the efficacy and safety of LAERCP. MATERIAL AND METHODS: We retrospectively reviewed all charts from RYGB patients who underwent a LAERCP between January 2009 and August 2019 in a non-academic referral center for bariatric surgery. Patients who underwent pancreatic therapy were excluded. We collected demographic, clinical, and outcome data. An adverse event was defined as any complaint related to the LAERCP up to 30 days after the procedure and graded according to the ASGE lexicon. RESULTS: We identified 100 LAERCP in 86 patients with RYGB (70% female, median age 54 years). Same-session cholecystectomy was performed in 35 LAERCP (35%). The papilla of Vater was visualized in 100% of LAERCP with a therapeutic success rate of 94%. Stone extraction succeeded in 88.8% and sphincterotomy was performed in 96.7%. We identified 30 adverse events in 28 procedures, of which eight endoscopy-related, 14 laparoscopy-related, and eight non-specified (f.i. fever, allergic reaction). In total, six severe adverse events were reported concerning post-ERCP pancreatitis (n = 2), laparoscopy-related hemorrhage (n = 1), abscess (n = 1), shock (n = 1), and pneumonia (n = 1). No patient died due to LAERCP. CONCLUSION: LAERCP is an effective and relatively safe procedure for biliary diseases in patients with RYGB.

An Extended Pouch in a Roux-En-Y Gastric Bypass Reduces Weight Regain: 3-Year Results of a Randomized Controlled Trial.

BACKGROUND: Although the Roux-en-Y gastric bypass (RYGB) is considered a standard procedure, many variations exist in the basic design. In order to achieve more pronounced and sustainable results after RYGB, factors such as diameter of the gastroenterostomy, limb length, and pouch size are gripping points for improvement of design. Extending the pouch could improve results by altering food passage through the pouch. OBJECTIVE: The aim of this randomized controlled trial was to evaluate the effect of an extended pouch RYGB (EP-GB) and standard pouch RYGB (S-GB). METHODS: In total, 132 patients were randomized in two groups: 68 patients received an EP-GB (pouch length 10 cm) and 64 a S-GB (pouch length 5 cm). Subsequently, weight loss, remission of comorbidities, nutritional status, complications, quality of life, and GERD-symptoms were assessed during a follow-up of 3 years. RESULTS: During the first 2 years of follow-up, no significant differences in terms of weight loss were observed. In the third year of follow-up, the S-GB group regained 3 kg, while in the EP-GB group no weight regain was observed. The mean TBWL after 36 months in the EP-GB group was 31% versus 27% in the S-GB group (p = 0.023). Additionally, besides a better remission rate of hypertension in the EP-GB group, no differences in complications, quality of life, and GERD-symptoms were found. CONCLUSION: Creation of an extended gastric pouch is a safe and effective modification in RYGB design. An EP-GB improves mid-term weight loss, potentially driven by a lower occurrence of weight regain.

Lightweight mesh is recommended in open inguinal (Lichtenstein) hernia repair: A systematic review and meta-analysis.

BACKGROUND: The use of lightweight mesh for inguinal hernia repair has been suggested to be preferable compared with heavyweight mesh. Nevertheless, surgeons do not use lightweight mesh routinely, possibly owing to the higher price and lack of confidence in evaluation of previous evidence. The aim of this systematic review and meta-analysis is to update the available randomized controlled trials and provide a recommendation on the use of lightweight mesh or heavyweight mesh in open inguinal hernia repair. METHODS: A literature search was conducted in May 2019 in MEDLINE, Embase and the Cochrane library for randomized controlled trials comparing lightweight (≤50 g/m2) and heavyweight (>70 g/m2) mesh in patients undergoing open (Lichtenstein) surgery for uncomplicated inguinal hernias. Outcomes were recurrences (overall, after direct or indirect repair), chronic pain (analyzing any and severe pain), and the feeling of a foreign body. The level of evidence was assessed using GRADE. Risk ratios and 95% confidence intervals were calculated by random effect meta-analyses. RESULTS: Twenty-one randomized controlled trials involving 4,576 patients (lightweight mesh 2,257 vs heavyweight mesh 2,319) were included. Follow-up ranged from 3 to 60 months. No difference between lightweight mesh and heavyweight mesh was determined for recurrence rates (lightweight mesh 42 of 2,068 and heavyweight mesh 34 of 2,132; risk ratios 1.22; 95% confidence interval, 0.76-1.96) or severe pain (lightweight mesh 14 of 1,517 and heavyweight mesh 26 of 1,591; risk ratios 0.73; 95% confidence interval, 0.38-1.41). A significant reduction was seen for any pain after lightweight mesh (234 of 1,603) compared with heavyweight mesh (322 of 1,683; risk ratios 0.78; 95% confidence interval, 0.64-0.96) and for the feeling of a foreign body (lightweight mesh 130 of 1,053 and heavyweight mesh 209 of 1,035; risk ratios 0.64; 95% confidence interval, 0.51-0.80). CONCLUSION: Lightweight mesh should be used in open (Lichtenstein) inguinal hernia repair.

A long biliopancreatic and short alimentary limb results in more weight loss in revisional RYGB surgery. Outcomes of the randomized controlled ELEGANCE REDO trial.

BACKGROUND: For a number of years the laparoscopic adjustable gastric band has been one of the leading bariatric procedures with good short-term outcomes. However, inadequate weight loss, weight regain, and other band-related complications in the long term led to an increase in revisional Roux-en-Y gastric bypass (RYGB) procedures. Lengthening the biliopancreatic limb, a relatively simple and safe adjustment of the standard technique, could improve the results of the revisional procedure. OBJECTIVES: The aim of this randomized controlled trial was to evaluate the effect of a long biliopancreatic limb RYGB (LBP-GB) and standard RYGB (S-GB) as revisional procedure after laparoscopic adjustable gastric band. SETTING: General hospital specialized in bariatric surgery METHODS: One hundred forty-six patients were randomized in 2 groups; 73 patients underwent an S-GB (alimentary/biliopancreatic limb 150/75 cm), and 73 patients underwent LBP-GB (alimentary/biliopancreatic limb 75/150). Weight loss, remission of co-morbidities, quality of life, and complications were assessed during a period of 4 years. RESULTS: Baseline characteristics between the groups were comparable. At 48 months the follow-up rate was 95%. Mean total weight loss after 24 months was 27% for LBP-GB versus 22% S-GB (P = .015); mean total weight loss after 48 months was 23% and 18%, respectively (P = .036). No significant differences in other parameters were found between the groups. CONCLUSIONS: A LBP-GB as revisional procedure after a failing laparoscopic adjustable gastric band improves short- and long-term total weight loss compared with an S-GB. Together with future modifications this technically simple adjustment of the RYGB could significantly improve disappointing results after revisional surgery.

Diagnosing Internal Herniation After Roux-en-Y Gastric Bypass Surgery: Literature Overview, Cadaver Study and the Added Value of 3D CT Angiography.

PURPOSE: The purposes of the study are to outline the complexity of diagnosing internal herniation after Roux-en-Y gastric bypass (RYGB) surgery and to investigate the added value of computed tomography angiography (CTA) for diagnosing internal herniation. MATERIALS AND METHODS: A cadaver study was performed to investigate the manifestations of internal hernias and mesenteric vascularization. Furthermore, a prospective, ethics approved study with retrospective interpretation was conducted. Ten patients, clinically suspected for internal herniation, were prospectively included. After informed consent was obtained, these subjects underwent abdominal CT examination, including additional arterial phase CTA. All subjects underwent diagnostic laparoscopy for suspected internal herniation. The CTA was used to create a 3D reconstruction of the mesenteric arteries and surgical staples (3D CTA). The 3D CTA was interpreted, taking into account the presence and type of internal hernia that was found upon laparoscopy. RESULTS: Cadaveric analysis demonstrated the complexity of internal herniation. It also confirmed the expected changes in vascular structure and surgical staple arrangement in the presence of internal herniation. 3D CTA studies of the subjects with active internal hernias demonstrated remarkable differences when compared to control 3D CTA studies. The blood supply of herniated intestinal limbs in particular showed abnormal trajectories. Additionally, enteroenterostomy staple lines had migrated or altered orientation. CONCLUSION: 3D CTA is a promising technique for diagnosing active internal hernias. Our findings suggest that for diagnosing internal hernias, focus should probably shift from routine abdominal CT examination towards the 3D assessment of the mesenteric vasculature and surgical staples.

Effectiveness and Safety of Sleeve Gastrectomy, Gastric Bypass, and Adjustable Gastric Banding in Morbidly Obese Patients: a Multicenter, Retrospective, Matched Cohort Study.

BACKGROUND: Laparoscopic adjustable gastric band (LAGB), laparoscopic sleeve gastrectomy (LSG), and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most performed procedures worldwide (92 %) nowadays. However, comparative clinical trials are scarce in literature. The objective of this study was to compare the effectiveness and safety of the three most performed bariatric procedures. METHODS: A multicenter, retrospective, matched cohort study was conducted. Patients were eligible for analysis when a primary procedure was performed between 2007 and 2010 in one of the two specialized bariatric centers. Primary outcome was weight loss, expressed in the percentage excess weight loss (%EWL). Secondary outcome parameters are hospital stay, complication rate, and revisional surgery. RESULTS: In total, 735 patients, 245 in each group, were included for analysis. The groups were comparable for age and gender after matching. Mean postoperative follow-up was 3.1 ± 1.2 years. LAGB patients showed less %EWL compared to LSG and LRYGB at all postoperative follow-up visits. LRYGB showed a %EWL of 71 ± 20 % compared to LSG (76 ± 23 %; p=0.008) after 1-year follow-up; thereafter, no significant difference was observed. After 3 years of follow-up, LAGB showed a higher complication rate compared to LSG and LRYGB (p<0.05). Revisional surgery after LAGB was needed in 21 %, while 9 % of the LSG underwent conversion to RYGB. CONCLUSIONS: LRYGB is a safe and effective treatment in morbid obese patients with good long-term outcomes. LSG seems to be an appropriate alternative as a definitive procedure, in terms of weight reduction and complication rate. LAGB is inferior to both LRYGB and LSG.

Fast-track bariatric surgery improves perioperative care and logistics compared to conventional care.

BACKGROUND: Due to the increased incidence of morbid obesity, the demand for bariatric surgery is increasing. Therefore, the methods for optimising perioperative care for the improvement of surgical outcome and to increase efficacy are necessary. The aim of this prospective matched cohort study is to objectify the effect of the fast-track surgery (FTS) programme in patients undergoing primary Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional perioperative care (CPC). METHODS: This study compared the perioperative outcome data of two groups of 75 consecutive morbid obese patients who underwent a primary LRYGB according to international guidelines in the periods January 2011-April 2011 (CPC group) and April 2012-June 2012 (FTS group). The two groups were matched for age and sex. Primary endpoints were surgery and hospitalisation time, while secondary endpoints were intraoperative medication use and complication rates. RESULTS: Baseline patient characteristics for age, sex, weight and ASA classification were similar (p > 0.05) for CPC and FTS patients. BMI and waist circumference were significantly lower (p < 0.05) in the FTS compared to CPC. The total time from arrival at the operating room to the arrival at the recovery was reduced from 119 to 82 min (p < 0.001). Surgery time was reduced from 80 to 56 min (p < 0.001); mean hospital stay was reduced from 65 to 43 h (p < 0.001). Major complications occurred in 3 versus 4 % in the FTS and CPC, respectively. CONCLUSIONS: The introduction of a fast-track programme after primary LRYGB improves short-term recovery and may reduces direct hospital-related resources.

Optimization of vitamin suppletion after Roux-en-Y gastric bypass surgery can lower postoperative deficiencies: a randomized controlled trial.

Iron, vitamin B12, and folic acid deficiencies are among the most common deficiencies occurring after laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study evaluates the effectiveness of a specially designed multivitamin supplement (WLS Forte, FitForMe, Rotterdam, the Netherlands) specifically developed for LRYGB patients.A triple-blind, randomized, 12-month study was conducted comparing WLS forte with a standard multivitamin supplement (sMVS) containing approximately 100% of the recommended daily allowance (RDA) for iron, vitamin B12, and folic acid. WLS Forte contains vitamin B12 14000% RDA, iron 500% RDA, and folic acid 300% RDA.In total, 148 patients (74 in each group) underwent a LRYGB procedure. Baseline characteristics were similar for both groups. Per protocol analysis demonstrated that sMVS treatment was associated with a decline in ferritin (-24.4 ±â€Š70.1 µg/L) and vitamin B12 (-45.9 ±â€Š150.3 pmol/L) over 12 months, whereas in WLS Forte patients, ferritin remained stable (+3.2 ±â€Š93.2 µg/L) and vitamin B12 increased significantly (+55.1 ±â€Š144.2 pmol/L). The number of patients developing ferritin or vitamin B12 deficiency was significantly lower with WLS Forte compared with sMVS (P < 0.05). Iron deficiency (ID) was reduced by 88% after WLS Forte compared with sMVS. Adverse events related to supplement use did not occur.An optimized multivitamin supplement is safe and reduces the development of iron and vitamin B12 deficiencies after LRYGB.

[European practice guidelines for the treatment of inguinal hernia: a summary]. / Europese richtlijn voor behandeling van liesbreuken: een samenvatting.

The European best practice guidelines on the treatment of inguinal hernia were published in 2009. Publications on this subject in international journals were updated in 2012. In patients with asymptomatic inguinal hernia or with minimal symptoms, conservative treatment is safe, but they do need to be informed that the risk for undergoing surgery increases by nearly 10% a year. Conservative treatment is less useful in younger patients. All adult men with symptomatic inguinal hernia need to undergo surgery. They should be treated with a technique in which a synthetic prosthesis (mesh) is used. The Lichtenstein technique is advised for the open treatment of inguinal hernia, since this is the most thoroughly evaluated technique. For endoscopic treatment, the European best practice guidelines advise the total extra-peritoneal technique. Nowadays the focus in complications is on the prevention of postoperative chronic pain.

PREVENTion of a parastomal hernia with a prosthetic mesh in patients undergoing permanent end-colostomy; the PREVENT-trial: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Parastomal hernia is a common complication of a colostomy. Ultimately, one-third of patients with a parastomal hernia will need surgical correction due to frequent leakage or life-threatening bowel obstruction or strangulation. However, treatment remains a challenge resulting in high recurrence rates. Two single center trials demonstrated that the frequency of parastomal hernias decreases by prophylactic placement of a mesh around the stoma at the time of formation. Unfortunately, both studies were small-sized, single-center studies and with these small numbers less common complications could be missed which were the reasons to initiate a prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable complications. METHODS: One hundred and fifty patients undergoing open procedure, elective formation of a permanent end-colostomy will be randomized into two groups. In the intervention group an end-colostomy is created with placement of a preperitioneal, retromuscular lightweight monofilament polypropylene mesh, and compared to a group with a traditional stoma without mesh. Patients will be recruited from 14 teaching hospitals in the Netherlands during a 2-year period. Primary endpoint is the incidence of parastomal hernia. Secondary endpoints are stoma complications, cost-effectiveness, and quality of life. Follow-up will be performed at 3 weeks, 3 months and at 1, 2, and 5 years. To find a difference of 20% with a power of 90%, a total number of 134 patients must be included. All results will be reported according to the CONSORT 2010 statement. DISCUSSION: The PREVENT-trial is a multicenter randomized controlled trial powered to determine whether prophylactic placement of a polypropylene mesh decreases the incidence of a parastomal hernia versus the traditional stoma formation without a mesh. TRIAL REGISTRATION: The PREVENT-trial is registered at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018.

The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh repair of primary inguinal hernia: a multicenter double-blind randomized controlled trial.

OBJECTIVE: To determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair. SUMMARY BACKGROUND DATA: A recent Cochrane meta-analysis (2003) concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded." METHODS: Patients with a primary inguinal hernia scheduled for Lichtenstein repair were randomized to a preoperative single dose of 1.5 g intravenous cephalosporin or a placebo. Patients with recurrent hernias, immunosuppressive diseases, or allergies for the given antibiotic were excluded. Infection was defined using the Centers for Disease Control and Prevention criteria. RESULTS: We included 1040 patients in the study between November 1998 and May 2003. According to the intention-to-treat principle, 1008 patients were analyzed. There were 8 infections (1.6%) in the antibiotic prophylaxis group and 9 (1.8%) in the placebo group (P = 0.82). There was 1 deep infection in the antibiotic prophylaxis group and 2 in the placebo group (P = 0.57). Statistical analysis showed an absolute risk reduction of 0.19% (95% confidence interval, -1.78%-1.40%) and a number needed to treat of 520 for the total number of infections. For deep infection, the absolute risk reduction is 0.20% (95% confidence interval, -0.87%-0.48%) with a number needed to treat of 508. CONCLUSIONS: A low percentage (1.7%) of wound infection after Lichtenstein open mesh inguinal (primary) hernia repair was found, and there was no difference between the antibiotic prophylaxis or placebo group. The results show that, in Lichtenstein inguinal primary hernia repair, antibiotic prophylaxis is not indicated in low-risk patients.