Prevention Of Parastomal Hernia Research Articles

Parastomal Hernia Prevention Using Funnel-Shaped Intra-Abdominal Mesh Compared to No Mesh

Prophylactic placement of a mesh has been suggested to prevent parastomal hernia. Evidence to support this practice is contradictory. To determine whether funnel-shaped permanent synthetic parastomal mesh is effective and safe in parastomal hernia prevention. The Chimney Trial was a randomized single-blinded multicenter trial conducted in 4 hospitals in Finland and 1 in Sweden from February 2019 and September 2021. Of 439 patients with rectal adenocarcinoma undergoing either laparoscopic or robotic-assisted abdominoperineal resection or the Hartmann procedure, 143 were enrolled in the trial, 135 received their allocated intervention, and 121 were analyzed at 12-month follow-up. Data were analyzed from December 2023 to May 2024. In the intervention group, a permanent colostomy was created with a funnel-shaped intraperitoneal mesh and compared to a control group with a stoma without the mesh. The primary end point was the incidence of computed tomography (CT)-confirmed parastomal hernia 12 months after surgery. There were 68 patients (mean [SD] age, 68.7 [11.6] years; 36 [53% male and 32 [47%] female) who received the intended allocation in the mesh group and 67 (mean [SD] age, 66.4 [11.7] years; 48 [72%] male and 19 [28%] female) who received the intended allocation in the control group. CT scans were available for 58 patients in the mesh group and 59 patients in the control group at the 12-month follow-up. CT scans confirmed parastomal hernia in 6 of 58 patients (10%) in the mesh group compared to 22 of 59 patients (37%) in the control group (difference, 27%; 95% CI, 12-41; P < .001). Clinical parastomal hernia as a secondary outcome was recorded in 1 of 60 patients (2%) in the mesh group compared to 27 of 61 (43%) in the control group (difference, 41%; 95% CI, 29-55; P < .001). The number of patients with Clavien-Dindo class II ileus was 23 (35%) in the mesh group compared to 11 (17%) in the control group (difference, 18%; 95% CI, 3-32; P = .006). Only slight differences between the groups were detected in other stoma-related complications, readmissions, operative time, surgical site infections, reoperations, and quality of life. In this study, funnel-shaped parastomal mesh prevented a significant number of parastomal hernias without predisposing patients to mesh- or stoma-related complications during 12-month follow-up. The results of this study suggest the funnel-shaped mesh is a feasible option to prevent parastomal hernia. ClinicalTrials.gov Identifier: NCT03799939.

Umbrella review of systematic reviews on the efficacy and safety of using mesh in the prevention of parastomal hernias.

This umbrella review aimed to summarize the findings and conclusions of published systematic reviews on the prophylactic role of mesh against parastomal hernias in colorectal surgery. PRISMA-compliant umbrella overview of systematic reviews on the role of mesh in prevention of parastomal hernias was conducted. PubMed and Scopus were searched through November 2023. Main outcomes were efficacy and safety of mesh. Efficacy was assessed by the rates of clinically and radiologically detected hernias and the need for surgical repair, while safety was assessed by the rates of overall complications. 19 systematic reviews were assessed; 7 included only patients with end colostomy and 12 included patients with either ileostomy or colostomy. The use of mesh significantly reduced the risk of clinically detected parastomal hernias in all reviews except one. Seven reviews reported a significantly lower risk of radiologically detected parastomal hernias with the use of mesh. The pooled hazards ratio of clinically detected and radiologically detected parastomal hernias was 0.33 (95%CI: 0.26-0.41) and 0.55 (95%CI: 0.45-0.68), respectively. Six reviews reported a significant reduction in the need for surgical repair when a mesh was used whereas six reviews found a similar need for hernia repair. The pooled hazards ratio for surgical hernia repair was 0.46 (95%CI: 0.35-0.62). Eight reviews reported similar complications in the two groups. The pooled hazard ratio of complications was 0.81 (95%CI: 0.66-1). The use of surgical mesh is likely effective and safe in the prevention of parastomal hernias without an increased risk of overall complications.

Ostomy Care Nurses' Knowledge and Practice Related to Prevention and Management of Parastomal Hernias in Adults: A Nationwide Survey of UK Stoma Care Nurses.

The purpose of this study was to describe the knowledge and practices of ostomy care nurses related to the United Kingdom's Association of Stoma Care Nurses (ASCN) 2016 guidelines for prevention and management of parastomal hernia (PSH) in adults. Cross-sectional descriptive study. The target population was approximately 300 stoma care nurses; 120 useable responses to the survey were received, reflecting a response rate of approximately 40%. A 31-item questionnaire was developed for the purposes of this study, consisting of multiple choice and short answer questions grouped into 2 sections; demographics, and knowledge and practices. The questionnaire was distributed to members of the ASCN who work with adults via an online survey platform with the aim of reaching as many respondents as possible. The Chi-square test was used to determine relationships between the nominal demographic data and the nominal knowledge and practices data. Almost two-thirds of respondents (65%, n =78) rated their knowledge relating to prevention and management of PSH as good or excellent. Nevertheless, 79.8% (n=95) indicated they needed additional education to improve their knowledge and practice related to prevention of PSH. Those who rated their knowledge as excellent or good were significantly more likely to be aware of the guidelines compared to those who ranked their knowledge as average or poor. Study findings suggest variability in knowledge among UK stoma care nurses, along with a desire for additional education in this area of care.

Proof of concept of an experimental prototype for the prevention of parastomal hernia.

The aim of this study was to analyse the complications and problems associated with the use of an experimental prototype designed for the prevention of parastomal hernia (PSH), one of the most frequent complications in ostomates. A single-centre, non-comparative, proof-of-concept interventional pilot study of an experimental prototype designed to be used in conjunction with an abdominal compression binder to prevent PSH was conducted. The "Ostomy Fixation Device for Hernia Prevention" (patent P201531826) is a semi-rigid ostomy protector, to be used in conjunction with a compression binder. It is designed to adapt to the dimensions of standard ostomy bags from different brands and serves to transmit, in a localised manner, the support coming from the compression binder in the peristomal area without putting pressure on the collection bag. The main outcome measures were efficacy, safety, and patient-users' opinion/perception. Ten patients were studied for 12 months. Mean age was 61 years (± 11.59), 70% (7) were male, 80% (8) ostomised for colorectal cancer, 90% (9) underwent planned surgery and 80% (8) had a colostomy. the incidence of HPE was 10% (1). no participant experienced pain, discomfort, itching, stinging, leakage, pouch detachment, allergy to components, or injury to the stoma or peristomal skin due to rubbing or pressure. 90% (n = 9) were considered "very satisfied" or "satisfied" with the device. An innovative device designed in collaboration between healthcare professionals and end-users has been shown to be safe and effective in reducing PSH in the group of ostomates studied.

Prophylactic surgical mesh placement as a prevention of parastomal hernia in open radical cystectomy with ileal conduit diversion - pilot study.

This study examines the efficacy of prophylactic mesh implantation during open radical cystectomy with ileal conduit diversion in preventing parastomal hernias (PH). Despite PH being a common complication, prophylactic methods have been underexplored. A pilot, single-center, prospective cohort study was conducted involving five patients undergoing surgery with mesh implantation. Demographic and clinical characteristics were monitored, including the incidence of PH, operation time, blood loss, and hospitalization duration. During the mean follow-up period of 9.1±3.2 months post-operation, no occurrences of PH were observed in the patient group. Despite the risks associated with implanting foreign material in an area of surgery involving open small intestine, no infectious complications were noted. Prophylactic mesh implantation in radical cystectomy with ileal conduit diversion appears to be an effective preventive measure against PH. Further extensive studies are required to definitively confirm the efficacy and safety of mesh use in this context.

Parastomal hernia prevention with an intraperitoneal prophylactic 3D-funnel mesh: review of the technique and middle-term results.

Parastomal hernia (PH) stands out as a prevalent complication following end colostomies, significantly affecting patients' quality of life. Various surgical strategies, predominantly involving prophylactic mesh deployment, have been explored with variable outcomes. This study details our experience and mid-term outcomes utilizing a funnel-shaped mesh. A single-center, prospective, non-randomized, observational study examined consecutive patients undergoing colorectal surgery with end colostomy, incorporating a 3D-funnel mesh from January 2019 to December 2021 (PM group). A historical cohort of patients with end colostomy without prophylactic mesh served as the comparison (C group). Postoperative morbidity within 30days was documented, and clinical examinations and radiological tests were employed for parastomal hernia diagnosis during follow-up. Seventy-two patients participated, with thirty-four in the PM group and thirty-eight in the C group. The PM group experienced 16 postoperative complications, unrelated to the mesh, while the C group recorded 20 complications (p = 0.672). Median follow-up was 22.06months for the PM group and 63.18months for the C group. The PM group exhibited a lower parastomal hernia incidence during follow-up (8.8%) compared to the C group(68.4%) (p < 0.001). Prophylactic use of a 3D-funnel mesh appears effective in reducing parastomal hernia incidence in the short and mid-term, without an associated increase in postoperative morbidity.

Development and preliminary evaluation of a novel procedure for creation of an ileal conduit stoma aimed at preventing parastomal hernia.

Our previous study suggested that the operative procedure is critical for the development of parastomal hernia. We developed a novel procedure for the creation of an ileal conduit stoma to prevent parastomal hernia. Herein we evaluate the efficacy and safety of the procedure. A total of 113 Japanese patients underwent radical cystectomy and ileal conduit diversion for bladder cancer from January 2017 through December 2021 at our institution. After excluding those with incomplete data, 103 patients consisting of 46 (44.7%) with the conventional procedure and 57 (55.3%) with the novel procedure were consecutively enrolled. The main points of the novel procedure are as follows: (1) the passage of the ileal conduit is ≤2.4 cm in diameter in principle; (2) the posterior rectus sheath and peritoneum are vertically incised 2 cm laterally from the middle of the stoma site to make an oblique passage for the ileal conduit; and (3) the anterior rectus sheath and posterior rectus sheath with peritoneum are fixed to the ileal conduit separately. Radiography-based parastomal hernia was observed in 11 patients (10.7%) with a median follow-up of 22.0 months. The incidences of parastomal hernia were 3.5% and 19.6% in the novel and the conventional procedure groups, respectively (p = 0.011). The former had a significantly lower cumulative incidence of parastomal hernia (p = 0.008, log-rank test). No specific complications associated with the procedure were observed. The results of the preliminary cohort study suggest that the novel procedure is safe and effective for the prevention of parastomal hernia.

Modified Approach for Extraperitoneal Colostomy Creation in Laparoscopic Abdominoperineal Resection.

Parastomal hernia is a major long-term complication after abdominoperineal resection. Extraperitoneal colostomy has been proposed as an effective step for parastomal hernia prevention, but it has not been widely used as it is technically demanding and time-consuming. We proposed a modified approach for extraperitoneal colostomy creation by entering the extraperitoneal space through the arcuate line of the posterior rectus sheath. To evaluate the safety, difficulty, and efficacy of long-term parastomal hernia prevention of the modified approach for extraperitoneal colostomy creation compared with the conventional transperitoneal colostomy approach. This was a retrospective evaluation of a surgical and video database. This was a single-institution retrospective study. Clinical data of 74 patients who underwent laparoscopic abdominoperineal resection surgery from January 2019 to January 2020 in the Department of General Surgery, Qilu Hospital of Shandong University, were retrospectively reviewed. Baseline characteristics, time required for colostomy creation (from skin incision to colostomy maturation), perioperative complications, and long-term colostomy-related complications were compared. Baseline characteristics did not differ between the 2 approaches. The BMI level ranged from 19.5 to 29.4 for patients undergoing extraperitoneal approach. Time required for colostomy creation median [interquartile range], (22 [21-25] minutes for extraperitoneal vs 23 [21-25] minutes for transperitoneal, p = 0.861) were comparable between the 2 approaches. The cumulative incidence of parastomal hernia was significantly greater with transperitoneal colostomy than extraperitoneal colostomy at 2 and 3 years postoperatively (16.2% vs 0%, p = 0.025, and 21.6% vs 0%, p = 0.005). The remaining perioperative complications and long-term colostomy-related complications did not differ between the 2 approaches. This study is limited by its retrospective design and small sample size. The modified approach for extraperitoneal colostomy creation is safe, technically simple, and effective for long-term parastomal hernia prevention in patients with a BMI of 19.5 to 29.4.

Effectiveness of placing prophylactic mesh with the Sugarbaker technique via laparoscopic abdominoperineal resection for rectal cancer: 1-year results

Abstract Background The aim of this study was to assess the efficacy of parastomal hernia prevention with the Sugarbaker technique via laparoscopic abdominoperineal resection for rectal cancer after a 1-year follow-up at University Medical Center in Ho Chi Minh City, Vietnam. Materials and Methods Prospective study. Between November 2018 and July 2022, 43 patients with low rectal cancer underwent laparoscopic abdominoperineal resection and were divided into 2 groups: study (n = 15) with prophylactic mesh placement with the Sugarbaker technique and control (n = 28). All patients were tracked for at least a year and had an abdominal computed tomography scan. The Kaplan-Meier method was used to calculate the rate of parastomal hernia after 1 year. To compare the rates of parastomal hernia in 2 groups, the log-rank test was used. Results This study included 43 patients, the male-to-female ratio was approximately equal to 1:1, the median age was 62 years, the youngest age was 40 years, and the oldest age was 92 years. Rectal cancer stage III was found in 41.8% of people. Neoadjuvant chemoradiotherapy was used in 27.9% of cases. The average duration of operation was 184 minutes. The average time for mesh placement was 15 minutes. The overall complication rate was 16.4%. There were no issues with mesh placement. At 1 year, the control group had a higher cumulative rate of parastomal hernia than the study group (35.7% vs 0%; log-rank test, 6.4; P = 0.01). Conclusions Prophylactic mesh placement with the Sugarbaker technique via laparoscopic abdominoperineal resection for rectal cancer is safe, does not increase complications, and reduces the cumulative rate of a parastomal hernia at 1 year in patients who have undergone prophylactic mesh placement.

EHS Rapid Guideline: Evidence-Informed European Recommendations on Parastomal Hernia Prevention-With ESCP and EAES Participation.

Background: Growing evidence on the use of mesh as a prophylactic measure to prevent parastomal hernia and advances in guideline development methods prompted an update of a previous guideline on parastomal hernia prevention. Objective: To develop evidence-based, trustworthy recommendations, informed by an interdisciplinary panel of stakeholders. Methods: We updated a previous systematic review on the use of a prophylactic mesh for end colostomy, and we synthesized evidence using pairwise meta-analysis. A European panel of surgeons, stoma care nurses, and patients developed an evidence-to-decision framework in line with GRADE and Guidelines International Network standards, moderated by a certified guideline methodologist. The framework considered benefits and harms, the certainty of the evidence, patients' preferences and values, cost and resources considerations, acceptability, equity and feasibility. Results: The certainty of the evidence was moderate for parastomal hernia and low for major morbidity, surgery for parastomal hernia, and quality of life. There was unanimous consensus among panel members for a conditional recommendation for the use of a prophylactic mesh in patients with an end colostomy and fair life expectancy, and a strong recommendation for the use of a prophylactic mesh in patients at high risk to develop a parastomal hernia. Conclusion: This rapid guideline provides evidence-informed, interdisciplinary recommendations on the use of prophylactic mesh in patients with an end colostomy. Further, it identifies research gaps, and discusses implications for stakeholders, including overcoming barriers to implementation and specific considerations regarding validity.

Update Systematic Review, Meta-Analysis and GRADE Assessment of the Evidence on Parastomal Hernia Prevention-A EHS, ESCP and EAES Collaborative Project.

Objective: To perform a systematic review and meta-analysis on the effectiveness of prophylactic mesh for the prevention of parastomal hernia in end colostomy, with the ultimate objective to summarize the evidence for an interdisciplinary, European rapid guideline. Methods: We updated a previous systematic review with de novo evidence search of PubMed from inception up to June 2022. Primary outcome was quality of life (QoL). Secondary outcomes were clinical diagnosis of parastomal hernia, surgery for parastomal hernia, and 30day or in-hospital complications Clavien-Dindo ≥3. We utilised the revised Cochrane Tool for randomised trials (RoB 2 tool) for risk of bias assessment in the included studies. Minimally important differences were set a priori through voting of the panel members. We appraised the evidence using GRADE and we developed GRADE evidence tables. Results: We included 12 randomized trials. Meta-analysis suggested no difference in QoL between prophylactic mesh and no mesh for primary stoma construction (SMD = 0.03, 95% CI [-0.14 to 0.2], I2 = 0%, low certainty of evidence). With regard to parastomal hernia, the use of prophylactic synthetic mesh resulted in a significant risk reduction of the incidence of the event, according to data from all available randomized trials, irrespective of the follow-up period (OR = 0.33, 95% CI [0.18-0.62], I2 = 74%, moderate certainty of evidence). Sensitivity analyses according to follow-up period were in line with the primary analysis. Little to no difference in surgery for parastomal hernia was encountered after pooled analysis of 10 randomised trials (OR = 0.52, 95% CI [0.25-1.09], I2 = 14%). Finally, no significant difference was found in Clavien-Dindo grade 3 and 4 adverse events after surgery with or without the use of a prophylactic mesh (OR = 0.77, 95% CI [0.45-1.30], I2 = 0%, low certainty of evidence). Conclusion: Prophylactic synthetic mesh placement at the time of permanent end colostomy construction is likely associated with a reduced risk for parastomal hernia and may confer similar risk of peri-operative major morbidity compared to no mesh placement. There may be no difference in quality of life and surgical repair of parastomal hernia with the use of either approach.

A preliminary report of laparoscopic extraperitoneal colostomy anterior to posterior sheath of rectus abdominis-transversus abdominis to prevent parastomal hernia

Objective: To examine the preliminary effect of laparoscopic extraperitoneal colostomy anterior to posterior sheath of rectus abdominis-transversus abdominis for the prevention of parastomal hernia after abdominoperineal resection for rectal cancer. Methods: This study is a prospective case series study. From June 2021 to June 2022, patients with low rectal cancer underwent laparoscopic abdominoperineal resection combined with extraperitoneal colostomy anterior to posterior sheath of rectus abdominis-transversus abdominis at the First Department of General Surgery, Shaanxi Provincial People's Hospital were enrolled. The clinical data and postoperative CT images of patients were collected to analyze the incidence of surgical complication and parastomal hernia. Results: Totally 6 cases of patient were enrolled, including 3 males and 3 females, aging 72.5 (19.5) years (M(IQR)) (range: 55 to 79 years). The operation time was 250 (48) minutes (range: 190 to 275 minutes), the stoma operation time was 27.5 (10.7) minutes (range: 21 to 37 minutes), the bleeding volume was 30 (35) ml (range: 15 to 80 ml). All patients were cured and discharged without surgery-related complications. The follow-up time was 136 (105) days (range: 98 to 279 days). After physical examination and abdominal CT follow-up, no parastomal hernia occurred in the 6 patients up to this article. Conclusions: A method of laparoscopic extraperitoneal colostomy anterior to posterior sheath of rectus abdominis-transversus abdominis is established. Permanent stoma can be completed with this method safely. It may have a preventive effect on the occurrence of parastomal hernia, which is worthy of further study.

Parastomal hernia prevention with permanent mesh in end colostomy: failure with late follow-up of cohorts in three randomized trials

PurposeShort-term results have been reported regarding parastomal hernia (PH) prevention with a permanent mesh. Long-term results are scarce. The objective was to assess the long-term PH occurrence after a prophylactic synthetic non-absorbable mesh.MethodsLong-term data of three randomized controlled trials (RCTs) were collected. The primary outcome was the detection of PH based exclusively on a radiological diagnosis by computed tomography (CT) performed during the long-term follow-up. The Kaplan–Meier method was used for the comparison of time to diagnosis of PH according to the presence of mesh vs. no-mesh and the technique of mesh insertion: open retromuscular, laparoscopic keyhole, and laparoscopic modified Sugarbaker.ResultsWe studied 121 patients (87 men, median age 70 years), 82 (67.8%) of which developed a PH. The median overall length of follow-up was 48.5 months [interquartile range (IQR) 14.4–104.9], with a median time until PH diagnosis of 17.7 months (IQR 9.3–49.0). The survival analysis did not show significant differences in the time to development of a PH according to the presence or absence of a prophylactic mesh neither in the overall study population (log-rank, P = 0.094) nor in the groups of each technique of mesh insertion, although according to the surgical technique, a higher reduction in the appearance of PH for the open retromuscular technique was found (log-rank, P = 0.001).ConclusionIn the long-term follow-up placement of a non-absorbable synthetic prophylactic mesh in the context of an elective end colostomy does not seem effective for preventing PH.

Perspectives of prevention and treatment of parastomal hernia-what do we really know and where should we go?

Parastomal hernia is a frequent complication after ostomy formation, causing a significant reduction of the quality of life of patients. In contrast to surgical dogmas dealing with the surgical technique of ostomy formation, mesh-based prophylaxis of parastomal hernia seemed to be effective, leading to the strong recommendation in the European Hernia Society(EHS) guidelines. More recent studies do not favor prophylaxis of parastomal hernia anymore, mainly due to the lack of clearly differentiating the techniques. The mostly used keyhole technique (flat mesh) cannot be equated with the “chimney technique” (3-dimensional mesh) that can be easily performed laparoscopically. Very recent results of the Finnish Randomized Study showed a dramatic reduction of parastomal hernia using the chimney technique. Concerning therapy of parastomal hernia, the chimney technique was also revealed to be effective. The laparoscopic “sandwich technique” should also be used therapeutically with very promising mid- and long-term results and seems to be superior to any other approaches. In a conclusion, investigating the prevention of parastomal hernia should clearly differentiate between the keyhole and chimney techniques and adopt strict technical standardization. Therapy of parastomal hernia should be based on the most effective sandwich or the chimney technique in specialized centers, according to recent registry results. Both techniques are based on the intraperitoneal placement of meshes requiring 3-dimensionality or the possibility of overlapping two meshes. Up to now, these requirements are only fulfilled by meshes made by polyvinylidene fluoride.

What should be included in case report forms? Development and application of novel methods to inform surgical study design: a mixed methods case study in parastomal hernia prevention

ObjectivesTo describe the development and application of methods to optimise the design of case report forms (CRFs) for clinical studies evaluating surgical procedures, illustrated with an example of abdominal stoma...

Effectiveness of placing prophylactic mesh with the Sugarbaker technique via laparoscopic abdominoperineal resection for rectal cancer

Abstract Introduction: The aim of this study was to assess the efficacy of parastomal hernia prevention with the Sugarbaker technique via laparoscopic abdominoperineal resection for rectal cancer after a one-year follow-up at University Medical Center in Ho Chi Minh City. Patients and methods: Intervention study. Between 11/2018 and 7/2022, 43 patients with low rectal cancer underwent laparoscopic abdominoperineal resection and were divided into two groups: intervention (n = 15) with prophylactic mesh placement using the Sugarbaker technique and control (n = 28). All patients were tracked for at least a year and had an abdominal computed tomography scan. The Kaplan Meier method was used to calculate the rate of parastomal hernia after one year. To compare the rates of parastomal hernia in two groups, the logrank test was used. Results: This study included 43 patients; the male to female ratio was approximately equal to 1:1; the median age was 62; the youngest age was 40; and the oldest age was 92. Rectal cancer stage III was found in 41.8% of people. Neoadjuvant chemoradiotherapy was used in 27.9% of cases. The average duration of operation was 184 minutes. The average time for mesh placement was 15 minutes. The overall complication rate was 16.4%. There were no issues with mesh placement. At one year, the control group had a higher cumulative rate of parastomal hernia than the intervention group (35.7% versus 0%, logrank 6.4, p = 0.01). Conclusions: Prophylactic mesh placement using the Sugarbaker technique during laparoscopic abdominoperineal resection for rectal cacner is safe, does not increase complications, and reduces the cumulative rate of a parastomal hernia at 1 year in patients who have undergone prophylactic mesh placement. Keywords: Prophylactic mesh placement, Sugarbaker technique, Laparoscopic abdominoperineal resection.

2021 Canadian Surgery Forum: Virtual, online Sept. 21-24, 2021.

# 01. Design and validation of a unique endoscopy simulator using a commercial video game {#article-title-2} Procedural simulation has been shown to enhance early endoscopy training. In this proof of concept study, we aimed to show that a first-person shooter (FPS) video game with a novel in-house

Prophylactic mesh placement at index permanent end colostomy creation to prevent parastomal hernia-an updated meta-analysis.

Debate persists regarding the efficacy of prophylactic mesh insertion (PMI) at index permanent stoma creation to reduce the rate of parastomal hernia (PSH). This meta-analysis aimed to appraise all the latest evidence from newly published randomized controlled trials (RCTs) on PMI for PSH prevention. PubMed, EMBASE, and Cochrane databases were searched for relevant articles from inception until November 2020. All RCTs that reported on PMI at end colostomy creation with ≥ 12 months follow-up were included. The primary objective was the rate of clinical and radiological PSH while secondary objectives included number of PSH requiring repair and stoma (or mesh)-related complications. Random effects models were used to calculate pooled effect size estimates. Sensitivity analyses were also performed. Eleven RCTs were included capturing 1097 patients. The mean (SD) age was 67.9 (±9.4) years. On random effects analysis, prophylactic mesh appeared to reduce the rate of both clinical (OR = 0.27, 95% CI = 0.12 to 0.61, p = 0.002) and radiological (OR = 0.39, 95% CI = 0.24 to 0.65, p = 0.0002) PSH. However, there was no difference in number of PSH requiring repair or stoma-related complications. On sensitivity analysis, when focusing on low-risk of bias studies, the benefit of prophylactic mesh in the retrorectus space was lost for both clinical (OR = 0.97, 95% CI = 0.62 to 1.51, p = 0.89) and radiological PSH (OR = 0.74, 95% CI = 0.46 to 1.18, p = 0.20). PMI may reduce the rate of subsequent PSH. However, further studies are required to confirm these findings and to establish the optimal mesh position and shape before definite recommendations can be made.

Prosthetic Mesh for Prevention of Parastomal Hernia: Neither Benefit nor "Meshed Ups".

Prosthetic Mesh for Prevention of Parastomal Hernia: Neither Benefit nor "Meshed Ups".

Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study).

Abdominal surgery sometimes necessitates the creation of a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia adjacent to and related to the stoma. PSH affects approximately 40% of patients within 2years of stoma formation. Complications of PSH reduce a patient's quality of life and can be severe (e.g. bowel obstruction). PSHs are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The aim of the CIPHER study is to investigate the influence of different surgical techniques on the development of PSH. The UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study) aims to recruit 4000 patients undergoing elective or expedited surgery with the intention of forming an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons will describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as a specimen extraction site and wound closure. The primary outcome will be incident PSH during follow-up, defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes will include surgical site infection, the Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources. Results of the study will be submitted for publication in peer-reviewed journals. All publications relating to the results of CIPHER will use a corporate authorship, 'The CIPHER Study Investigators' with named writing committee members. The CIPHER study will be the first to investigate detailed surgical methods of stoma formation in a large, representative cohort of patients with a range of primary indications, both cancer and noncancer.