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Stoma Hernia Intraperitoneal Full-Thickness Skin

Stoma Hernia Intraperitoneal Full-Thickness Skin

Recruiting
18 years and older
All
Phase N/A

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Overview

This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.

Description

Parastomal hernia is a common complication to a stoma which can cause considerable suffering for the patient. The conventional methods of repair available today have disappointing results with high recurrence rates and serious complications. Some of the complications can be related to the introduction of foreign material into the abdominal wall. The investigators hypothesis is that the use of autologous full-thickness skin graft as reinforcement material can offer an alternative with fewer complications and recurrences.

Patients with symptomatic parastomal hernia will be included in a prospective randomized multicenter study comparing reinforcement with conventional synthetic mesh (with the best available technique today), to full thickness skin grafts placed in an intraperitoneal position. The intervention will be blinded to the participants, nursing staff and the follow-up staff. The participants will be followed up at 3, 12 and 36 months monitoring complications, recurrences, quality of life, strength of the abdomino-lumbar girdle and calculations will be done on the health economics.

Eligibility

Inclusion Criteria:

  • Colo-, ileo- or urostomy
  • Parastomal hernia diagnosed with intrastomal ultrasound and/or CT
  • Symptoms from the parastomal hernia requiring surgical intervention
  • Informed consent
  • >18 years of age
  • Sufficient knowledge in the Swedish language so that questionnaires can be answered

Exclusion Criteria:

  • Cognitive impairment unabling compliance to post-operative prescriptions and/or answering questionnaires
  • Insufficient amount of good quality skin suitable for transplantation
  • Expected high donor-site morbidity
  • Fistula/e adjacent to stoma
  • Mb Crohn

Study details
    Parastomal Hernia

NCT03667287

Umeå University

25 January 2024

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