Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorState Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Government
Locations1 site (Krasnodar)
StatusRecruiting
StartedJanuary 12, 2024
Main results expectedDecember 12, 2026
Study endsDecember 12, 2029
Registry record updatedJanuary 21, 2026
Trial IDNCT06474403 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.