Comparing surgical methods for repairing parastomal hernias
Full-thickness Skin vs. Synthetic Mesh in the Repair of Parastomal Hernia
This study is testing two different surgical methods for fixing parastomal hernias to see which one helps patients feel better and have fewer problems afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 2 sites (Luleå, Norrbotten and 1 other locations) |
| Trial ID | NCT03667287 on ClinicalTrials.gov |
What this trial studies
This prospective randomized study aims to compare two surgical methods for repairing parastomal hernias: the conventional synthetic mesh technique and the use of autologous full-thickness skin grafts. Parastomal hernias are a common complication of stomas that can lead to significant patient discomfort and high recurrence rates with traditional repair methods. The study will involve patients with symptomatic parastomal hernias, who will be randomly assigned to one of the two intervention groups. Participants will be monitored for complications, recurrence rates, quality of life, and abdominal strength over a follow-up period of 36 months.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with symptomatic parastomal hernias requiring surgical intervention.
Not a fit: Patients with cognitive impairments, insufficient skin for grafting, or certain medical conditions like Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective surgical option for patients suffering from parastomal hernias.
How similar studies have performed: While the use of synthetic mesh is common, the approach of using autologous skin grafts for this purpose is relatively novel and has not been widely tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Luleå, Norrbotten and 1 other locations
- Sunderby Hospital — Luleå, Norrbotten, Sweden (Not_yet_recruiting)
- University Hospital of Umeå — Umeå, Västerbotten, Sweden (Recruiting)
Study contacts
- Principal investigator: Karin Strigård, PhD — Umeå University, Department of Surgical and Perioperative sciences
- Study coordinator: Viktor Holmdahl, MD
- Email: viktor.holmdahl@umu.se
- Phone: +4690 785 00 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.