NCT06474403 Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
| NCT ID | NCT06474403 |
| Status | Recruiting |
| Phase | — |
| Sponsor | State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital |
| Condition | Parastomal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-12 |
| Primary Completion | 2026-12-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-12 with a primary completion date of 2026-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Abstract: Parastomal hernia is a frequent complication following stoma formation, presenting a significant surgical challenge with high recurrence rates. The present study explores the efficacy of the laparoscopic total extraperitoneal (TEP) approach in parastomal hernia repair, conceived as a modification of the Sugabecker's operation. This prospective work, who analysis aims to evaluate the feasibility, safety, and recurrence rates associated with this minimally invasive technique. Methods: A comprehensive review of patients undergoing laparoscopic TEP parastomal hernia repair between 2024 and 2026 will be performed. Patient demographics, operative details, intraoperative complications, postoperative morbidity, recovery times, and hernia recurrence rates will be collate and analyze. Results: The study will include 30 patients with a median follow-up period of 1month (firstly viewer's point) and 12 months (second view point ). The all of parastomal hernias will associated with colostomies. Early mobilization will achieve, with most patients returning to their routine activities within 2 weeks. Discussion: We anticipate that the data will suggest the laparoscopic TEP technique for parastomal hernia repair is a viable alternative to traditional methods, with a favorable safety profile. The minimally invasive nature of the operation appears to facilitate enhanced recovery while maintaining low recurrence rates. Compared to the original Sugarbaker operation, where the mesh is placed intraperitoneally, the extraperitoneal placement of the mesh in TEP repair minimizes the potential for adhesion formation and related complications. Furthermore, aesthetic outcomes and patient satisfaction reports indicate a positive outlook. Conclusion: The laparoscopic TEP approach for parastomal hernia repair offers a modification to the Sugarbaker operation with potential benefits, including reduced operative morbidity, faster recovery, and potentially lower recurrence rates. Extended follow-up and comparison with the traditional approach are warranted to conclusively establish the long-term outcomes of this technique. This study contributes to the evolving surgical management of parastomal hernias, advancing towards less invasive and more patient-centered treatment modalities.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06474403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parastomal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06474403 currently recruiting?
Yes, NCT06474403 is actively recruiting participants. Contact the research team at a_petrovsky@mail.ru for enrollment information.
Where is the NCT06474403 trial being conducted?
This trial is being conducted at Krasnodar, Russia.
Who is sponsoring the NCT06474403 clinical trial?
NCT06474403 is sponsored by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital. The trial plans to enroll 50 participants.