Protocol for EHS Rapid Guideline: Systematic Review, Meta-Analysis, GRADE Assessment, and European Recommendations on Parastomal Hernia Prevention

Abstract

Background: Parastomal hernia presents frequently after construction of a permanent end colostomy. Previous guidelines recommend using a prophylactic mesh for hernia prevention. Randomized controlled trials (RCTs) published hereafter demonstrate conflicting outcomes.Methods and Analysis: A rapid guideline will be developed and reported in accordance with GRADE, GIN and AGREE-S standards. The steering group will consist of general and colorectal surgeons, members of the EHS Scientific Advisory Board with expertise and experience in guideline development, advanced medical statistics and evidence synthesis, and a certified guideline methodologist. The guideline panel will consist of three general surgeons, three colorectal surgeons, two stoma care nurses, and two patient representatives. A single question will address the safety and efficacy of the use of a prophylactic mesh in patients with a permanent end colostomy, and sensitivity analyses will focus on the use of non-absorbable versus absorbable meshes, and on different anatomical spaces for mesh placement. A systematic review will be conducted and evidence synthesis will be performed by statisticians independently. The results of evidence synthesis will be summarized in summary of findings tables. Recommendation(s) will be finalized through Delphi process of the guideline panel within an evidence-to-decision framework.Ethics and Dissemination: The funding body will not be involved in the development of this guideline. Conflicts of interest, if any, will be addressed by re-assigning functions or replacing participants with direct conflicts, according to Guidelines International Network recommendations.

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

“…The guideline methodologist and a member of the steering group (FM) were coordinators of the previous EHS guideline on prevention and treatment of parastomal hernias [ 1 ]. The third member of the steering group (CS) acted as content coordinator of this project and disclosed no direct nor indirect conflict [ 16 ]. We therefore consider that a potential indirect conflict of the coordinators of the original guideline has not affected the content of this guideline.…”

“…The composition of panel members aimed to be representative of different parts of Europe and different age groups. Panel members disclosed no direct nor indirect conflicts [ 16 ]. We invited authors of randomized trials and evidence syntheses on the topic of interest as external advisors.…”

“…These members were not involved in the decisions on the strength, the direction or the wording of the recommendations, but they were consulted in the development of the evidence-to-decision framework, as per GRADE and GIN guidance. The composition of the guideline development group and members’ roles are available in the online appendix [ 16 ].…”

“…A protocol was developed a priori by the steering group [ 17 ]. The protocol draft was made publicly available through the social media, and the public was invited to comment on the content.…”

“…The importance of outcomes was rated by panel members using the GRADE scale [ 18 ]. The classification of outcomes into each of the three categories (not important, important, critical) was made by the steering group under consideration of panel members’ ratings available online (scale from 1 to 9, from the least to the highest importance) [ 16 ]. The final rating was the median of panel members’ ratings, since there was no substantial deviation from the median.…”