Dataset Information

Autologous full-thickness skin graft as reinforcement in parastomal hernia repair: a randomised controlled trial.

ABSTRACT:

Background

Parastomal 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.

Methods

This 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.

Discussion

Parastomal 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 registration

ClinicalTrials.gov NCT03667287. Registered on September 12, 2018.

SUBMITTER: Holmdahl V

PROVIDER: S-EPMC8650734 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundAspiring endoscopic surgery with extraperitoneal mesh application to avoid adhesion and pain from mesh fixation, we adopted the principles of the open Pauli repair of parastomal hernia (PSH). We have termed the procedure ePauli repair. The aim of this account is to inform about feasibility and adverse reactions.MethodsPatients with PSH selected for ePauli repair with transversus abdominis release (TAR) were enrolled in a prospective observational study. Patients were operated with laparoscopic or robotic assistance and endoscopic Rives-Stoppa repair in cases with concomitant midline hernia. Coated meshes or a buffer mesh was used in the retromuscular pocket for this modification of the Sugarbaker principle.ResultsFifteen patients were included: six patients were operated laparoscopically and nine patients with robotic assistance. The median age of the stomas was 33 months (7-313). Five PSHs were recurrent after previous repairs. Median operating time without midline hernia repair was 156 min (107-233) and with midline hernia repair 241 min (176-286). One serosa lesion arose during operation, prompting intraoperative revision of the ostomy without postoperative morbidity. Two patients had postoperative obstruction and were readmitted to operation: one with multiple adhesions and one had kinking of the stoma bowel caused by insufficient incision of the transversalis fascia. No infections or seromas have been observed. One patient had discoloring of the flank with spontaneous remission, and one patient had recurrence. Median postoperative admission time was 3 days (1-19). Median follow-up is 10 months (0-27).ConclusionsePauli repair is technically challenging but feasible. With our limited experience, we are encouraged with the pain, complication, and functional summary after ePauli repair and hopeful for the recurrence profile. ePauli/TAR is not for every patient or every surgeon and whether it should be restrained to recurrent PSH or be offered as first-line treatment for PSH is disputable.