Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
Launched by STATE BUDGET PUBLIC HEALTH INSTITUTION SCIENTIFIC RESEARCH INSTITUTE - OCHAPOVSKY REGIONAL CLINICAL HOSPITAL · Jun 19, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new surgical method called laparoscopic total extraperitoneal (TEP) repair for parastomal hernias, which often occur after stoma surgery. The trial aims to determine how safe and effective this minimally invasive technique is compared to traditional methods. The researchers will look at various factors, including recovery times and the chances of the hernia coming back after surgery, by analyzing data from patients who undergo this procedure.
To be eligible for the trial, participants should be adults diagnosed with a parastomal hernia that is causing symptoms and requires surgery. They need to be able to have the procedure done under general anesthesia and provide informed consent. During the study, participants can expect to undergo the laparoscopic surgery and, based on initial findings, most are likely to return to their normal activities within two weeks. The trial is currently recruiting participants and hopes to demonstrate that this new approach leads to quicker recovery and fewer complications than traditional surgery.
Gender
ALL
Eligibility 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.
About State Budget Public Health Institution Scientific Research Institute Ochapovsky Regional Clinical Hospital
The Ochapovsky Regional Clinical Hospital is a state-funded public health institution dedicated to advancing medical knowledge and patient care through rigorous scientific research. As a prominent clinical trial sponsor, the hospital focuses on innovative health solutions, fostering collaboration among healthcare professionals and researchers to evaluate new treatments and improve clinical practices. With a commitment to enhancing public health outcomes, the institute plays a vital role in conducting ethical and impactful clinical trials, contributing to the advancement of evidence-based medicine in the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Krasnodar, , Russian Federation
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported