Clinical trial NCT06474403: Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation
Official title: The Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parastomal Hernia
Keywords: Parastomal Hernia
Hernia Recurrence
Minimally Invasive Surgery
Sugabecker's Operation
Lead sponsor: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This randomized controlled trial aims to assess the efficacy and safety of a modified Sugarbaker technique in the laparoscopic total extraperitoneal repair of parastomal hernias.
Primary purpose: TREATMENT

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.

Detailed description: Introduction:

Parastomal herniation presents as a common complication following stomal surgeries, creating significant morbidity and adversely impacting the quality of life for patients. Traditional open surgical techniques, including Sugabecker's operation, offer variable success rates and potential complications. This study proposes an adaptation utilizing a laparoscopic total extraperitoneal (TEP) approach, tailored to enhance the original Sugabecker method while aiming to reduce the perioperative morbidity and recurrence rates associated with parastomal hernia repairs.

Objective:

The primary objective of this research is to investigate the laparoscopic TEP parastomal hernia repair as a modification of the Sugabecker's operation and to assess its outcomes in terms of feasibility, safety, and hernia recurrence rate.

Brief Protocol Description:

Eligible candidates who have developed parastomal hernias following stoma creation and consented to the study will undergo laparoscopic TEP repair. The procedure involves an initial unilateral transrectal incision followed by the creation of an preperitoneal or retro-rectus space where a mesh is positioned to reinforce the abdominal wall and the stoma. Also it will has was formed oblique hernia canal. The operative and postoperative outcomes of these patients will be studied in comparison with control group treated with the traditional Sugabecker's operation.

Scientific Hypothesis:

The hypothesis underpinning this research is that a laparoscopic TEP approach to parastomal hernia repair, modifying Sugabecker's procedure, can provide more favorable outcomes, for example: less intraoperative trauma, fewer bowel injuries due to adhesiolysis, and fewer intestinal perforations. Specifically, it is expected that this minimally invasive method will result in a significant reduction in postoperative pain, shorter hospital stays, faster recovery, decreased morbidity, and lower hernia recurrence rates in comparison with the traditional Sugabecker's or Paul's operations.

Expected Results:

This study anticipates that the laparoscopic TEP repair will demonstrate:

1. A safe and reproducible procedure adaptable to different hernia sizes and locations around stomas.
2. Reduced immediate intra - and postoperative complications, including infections and hematoma formation.
3. Quicker patient mobilization and discharge times when compared with the open approach.
4. A statistically significant reduction in parastomal hernia recurrence over a long-term follow-up when matched against controls who have undergone traditional Sugabecker's repair.
5. High patient satisfaction scores and improved quality of life indicators due to the minimally invasive nature of the repair.

In conclusion, through a detailed analysis of perioperative outcomes, long-term follow-up, and comparative studies with traditional methods, this research aims to establish the laparoscopic TEP approach as a superior modification to parastomal hernia repair, upholding the tenets of enhanced recovery and patient-centered care.

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.

Primary outcomes:
measure: Recurrence Rate of Parastomal Hernia
timeFrame: 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 outcomes:
measure: Incidence of Infectious Complications at the Surgical Site and Mesh Placement Area
timeFrame: Assessed at post-operative days 1, 3, 7, 14, and during follow-up visits at 1 month, 3 months, and 6 months
measure: Quality of Life Assessment - Short Form Health Survey (SF-36) Score
timeFrame: Assessed pre-operation and at 3 months, 6 months, 1 year, and 2 years post-operation
measure: Length of Hospital Stay
timeFrame: From date of surgery until hospital discharge, assessed up to 30 days
measure: Intra-operative Complications
timeFrame: During operation
measure: Postoperative Pain Levels -Visual Analog Scale (VAS) for Pain
timeFrame: Assessed at 24 hours, 72 hours, and 7 days post-operation
Other outcomes:
Locations:
city: Krasnodar
country: Russian Federation
facility: S.V. Ochapovsky Regional Clinical Hospital #1
Study officials:
References: