Stoma Hernia Intraperitoneal Full-Thickness Skin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2025-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Parastomal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Full-thickness skin graft

Repair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement.

Group Type EXPERIMENTAL

Repair of parastomal hernia

Intervention Type PROCEDURE

Surgical repair of symptomatic parastomal hernia.

Synthethic mesh

Repair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement

Group Type ACTIVE_COMPARATOR

Repair of parastomal hernia

Intervention Type PROCEDURE

Surgical repair of symptomatic parastomal hernia.

Interventions

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Repair of parastomal hernia

Surgical repair of symptomatic parastomal hernia.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No