Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Umeå University
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Rate of complications at 3 months
Study Overview
Brief Summary
This is a prospective randomized study to compare surgical methods for the repair of parastomal hernia.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Full-thickness skin graft
Repair of parastomal hernia with full-thickness skin graft, placed intraperitoneally, as reinforcement.
Intervention: Repair of parastomal hernia (Procedure)
Synthethic mesh
Repair of parastomal hernia with best available conventional method, using synthetic mesh material as reinforcement
Intervention: Repair of parastomal hernia (Procedure)
Outcomes
Primary Outcomes
Rate of complications at 3 months
Time Frame: 3 month post-operative clinical follow-up
Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation.
Secondary Outcomes
- QoL - EORTC C30(3, 12 and 36 months.)
- Abdominal strength(12 and 36 months.)
- Recurrence(3, 12 and 36 months)
- Pain - VHPQ(3, 12 and 36 months.)
- QoL - EORTC CR29(3, 12 and 36 months.)
- Health economics(12 and 36 months.)
- Rate of complications at 12 months(12 month post-operative clinical follow-up)
- Rate of complications at 36 months(36 month post-operative clinical follow-up)