Laparoscopic approach to repair parastomal hernias
The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation
This study is testing a new minimally invasive surgery to fix parastomal hernias in patients to see if it works better and has fewer complications than the traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital Government |
| Locations | 1 site (Krasnodar) |
| Trial ID | NCT06474403 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a laparoscopic total extraperitoneal (TEP) technique as a modification of the Sugabecker's operation for repairing parastomal hernias. It aims to assess the feasibility, safety, and recurrence rates associated with this minimally invasive surgical approach. A total of 30 patients with symptomatic parastomal hernias will be included, and their outcomes will be compared to those undergoing traditional Sugabecker's operation. Data on operative details, complications, recovery times, and hernia recurrence will be collected and analyzed over a follow-up period of up to 12 months.
Who should consider this trial
Good fit: Ideal candidates are adults with symptomatic parastomal hernias following stoma creation who can undergo surgery under general anesthesia.
Not a fit: Patients with contraindications to laparoscopic surgery or those requiring urgent care for incarcerated hernias will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to lower recurrence rates and improved recovery times for patients with parastomal hernias.
How similar studies have performed: While traditional methods have variable success rates, this novel laparoscopic approach has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients with a confirmed diagnosis of parastomal hernia post-stoma creation surgery; 2. Symptomatic hernias requiring surgical intervention; 3. Able to undergo the surgical approach under general anesthesia; 4. Patients who can provide informed consent. Non-Inclusion Criteria: Patients with contraindications to laparoscopic surgery, such as uncontrolled coagulopathies, severe cardiorespiratory conditions, or extensive intra-abdominal adhesions are excluded. Those with ongoing peritonitis, incarcerated hernias requiring urgent care, or malignancy at the hernia site are also excluded. Exclusion Criteria: * Patients unwilling to provide informed consent; * Patients with a life expectancy less than the study follow-up period; * Patients who have previously undergone other types of hernia repair, which could confound the operative and postoperative outcomes being measured.
Where this trial is running
Krasnodar
- S.V. Ochapovsky Regional Clinical Hospital #1 — Krasnodar, Russia (Recruiting)
Study contacts
- Study coordinator: Aleksandr Petrovsky, MD, PhD
- Email: a_petrovsky@mail.ru
- Phone: +79094648456
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.