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

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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p>The PREVENT-trial is registered at: <url>http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2018</url></p