Laparoscopic approach to repair parastomal hernias
Official title: The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation
Run by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital · NCT06474403 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital Government |
| Locations | 1 site (Krasnodar) |
| Status | Recruiting |
| Started | January 12, 2024 |
| Main results expected | December 12, 2026 |
| Study ends | December 12, 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT06474403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with symptomatic parastomal hernias following stoma creation who can undergo surgery under general anesthesia.
✕Probably not a fit
Patients with contraindications to laparoscopic surgery or those requiring urgent care for incarcerated hernias will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While traditional methods have variable success rates, this novel laparoscopic approach has not been extensively tested in prior studies.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.