Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
NCT Number: NCT06474403
Acronym: LTEPP
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parastomal Hernia
Interventions: PROCEDURE: standard Sugarbecker's operation|PROCEDURE: modified Sugarbecker's operation
Sponsor: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-01-12
Completion Date: 2029-12-12
Locations: S.V. Ochapovsky Regional Clinical Hospital #1, Krasnodar, 350040, Russian Federation

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.

Primary Outcome Measures: Recurrence Rate of Parastomal Hernia, This outcome measures the rate at which the hernias recur post-surgery after using the laparoscopic total extraperitoneal parastomal hernia repair technique modified from the traditional Sugarbaker's operation. A recurrence constitutes any hernia that reappears in the region of the stoma where the surgery was initially performed., 1 year post-operation Ensure that the timelines, definitions, and other details reflect the specific procedures and follow-ups that are planned for the clinical trial being discussed.
Secondary Outcome Measures: Incidence of Infectious Complications at the Surgical Site and Mesh Placement Area, This measure tracks the occurrence of infectious complications at the site of the surgical wound and where the mesh is placed. Such complications include signs of infection at the incision site, such as redness, swelling, and discharge, as well as deeper infections involving the mesh., Assessed at post-operative days 1, 3, 7, 14, and during follow-up visits at 1 month, 3 months, and 6 months|Quality of Life Assessment - Short Form Health Survey (SF-36) Score, The SF-36 is a 36-item patient-reported survey of patient health, measuring 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0 to 100, with higher scores indicating better health status/quality of life., Assessed pre-operation and at 3 months, 6 months, 1 year, and 2 years post-operation|Length of Hospital Stay, Tracking the duration from the completion of surgery until discharge to assess the potential impact of the laparoscopic total extraperitoneal approach on recovery times., From date of surgery until hospital discharge, assessed up to 30 days|Intra-operative Complications, Monitoring and recording of any complications that occur during the surgery, including but not limited to, bowel injury, bleeding, or unexpected conversion to open surgery., During operation|Postoperative Pain Levels -Visual Analog Scale (VAS) for Pain, The VAS is a continuous scale comprised of a horizontal line, 100 mm in length, anchored by two verbal descriptors, one for each symptom extreme (e.g. "no pain" and "worst possible pain"). Patients mark a point on the line that represents their current level of pain. Scores range from 0 (no pain) to 100 (worst possible pain), with higher scores indicating more severe pain., Assessed at 24 hours, 72 hours, and 7 days post-operation