Stoma Hernia Intraperitoneal Full-Thickness Skin (SHIFT)

Umeå University

Status: Enrolling

Conditions: Parastomal Hernia

Treatments: Procedure: Repair of parastomal hernia

Study type: Interventional

Funder types: Other

Identifiers

NCT03667287

2017-251-31M

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

Full-thickness skin graft

Experimental group

Description:

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

Treatment:

Procedure: Repair of parastomal hernia

Synthethic mesh

Active Comparator group

Description:

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

Treatment:

Procedure: Repair of parastomal hernia