Abstract
BackgroundParastomal hernia is a common complication of an enterostomy and can have a significant impact on health-related quality of life. Currently used methods of repair have high recurrence rates and considerable risk for complications. We have developed a new technique for parastomal hernia repair that uses full-thickness skin graft as reinforcement.MethodsThis study protocol describes a multicentre randomised controlled trial on parastomal hernia repair comparing a new full-thickness skin graft technique with conventional synthetic composite mesh as reinforcement of the abdominal wall. Patients with a symptomatic parastomal hernia will be included and followed up at 3, 12 and 36 months, with surgical complication as the primary outcome. Secondary outcomes will be recurrence rate and health-related quality of life assessed with VHPQ, EORTC C30 and CR29. Tissue biology and collagen metabolism will be investigated pre- and postoperatively using biopsies of the abdominal wall fascia and blood samples.DiscussionParastomal hernia constitutes a major clinical problem where the prospects of a good result after hernia repair are presently poor. This new method of repair with full-thickness skin grafting could be a new alternative in our surgical toolbox, but before then, it must be evaluated properly.Trial registrationClinicalTrials.gov NCT03667287. Registered on September 12, 2018
Highlights
Background and rationale {6a} Parastomal hernia is the main complication of an enterostoma [1,2,3]
Several techniques are presently used for parastomal hernia repair
Pain and quality of life Evaluated with Ventral Hernia Pain Questionnaire (VHPQ) and EORTC CR29 and CR30 respectively and answers are reported and scored according to their specific scoring manuals
Summary
Background and rationale {6a} Parastomal hernia is the main complication of an enterostoma [1,2,3]. The European Hernia Society recommends a synthetic mesh plasty, but scientific evidence on how and in what position the reinforcing material should be applied is weak. Even the best available methods today are associated with high recurrence rates and significant risk for complications that can be fatal [7,8,9]. The use of synthetic mesh material is associated with severe complications such as mesh infection, fistula formation and erosion of the intestines [9]. There are patient associations and other communities that oppose the use of synthetic mesh material (https://www.facebook.com/ groups/meshproblems/, https://www.facebook.com/ MeshMeNot/, https://meshmenot.wordpress.com/, https:// meshvictimsunited.org/). Used methods of repair have high recurrence rates and considerable risk for complications. We have developed a new technique for parastomal hernia repair that uses full-thickness skin graft as reinforcement
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