Laparoscopic Total Extraperitoneal Plasty as a Modification of Sugabecker's Operation

NCT06474403 | Recruiting DMC

• 1 other identifier: LTEPPHR - 030524
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Parastomal Hernia

Keywords

Parastomal Hernia; Hernia Recurrence; Minimally Invasive Surgery; Sugabecker's Operation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of Infectious Complications at the Surgical Site and Mesh Placement Area

  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

  Assessed pre-operation and at 3 months, 6 months, 1 year, and 2 years post-operation

• Length of Hospital Stay

  From date of surgery until hospital discharge, assessed up to 30 days

• Intra-operative Complications

  During operation

• Postoperative Pain Levels -Visual Analog Scale (VAS) for Pain

  Assessed at 24 hours, 72 hours, and 7 days post-operation

Study Arms (2)

standard Sugarbecker's operation

OTHER

patients this group will receive the standard Sugarbaker parastomal hernia repair, a well-established technique involving the placement of as an IPOM mesh replacement to reinforce the abdominal wall.

Procedure: standard Sugarbecker's operation

modified Sugarbecker's operation

OTHER

patients this group will undergo a modified technique where the mesh is positioned entirely within the extraperitoneal space

Procedure: modified Sugarbecker's operation

Interventions

standard Sugarbecker's operation PROCEDURE

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.

standard Sugarbecker's operation

modified Sugarbecker's operation PROCEDURE

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.

modified Sugarbecker's operation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with a confirmed diagnosis of parastomal hernia post-stoma creation surgery;
• Symptomatic hernias requiring surgical intervention;
• Able to undergo the surgical approach under general anesthesia;
• Patients who can provide informed consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital: lead

Study Sites (1)

S.V. Ochapovsky Regional Clinical Hospital #1

Krasnodar, 350040, Russia

RECRUITING

Central Study Contacts

Aleksandr Petrovsky, MD, PhD

CONTACT

+79094648456; a_petrovsky@mail.ru

Vadim Polovinkin, MD, PhD

CONTACT

+7 (918) 65-66-727; vvpolovinkin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical trial incorporates a double-blind design. Neither participants nor the surgeons performing the procedures will be informed about whether a patient is receiving the modified Sugarbaker's operation or a standard parastomal hernia repair technique. The intent is to prevent any potential bias in surgical performance and postoperative care. Outcome assessors analyzing recovery data, hernia recurrence rates, and complication rates will also be blinded to the intervention received by each participant. This ensures an unbiased collection and interpretation of data, enhancing the validity of the trial outcomes. Specific measures will have been taken to maintain blinding, including the use of identical operative room setup and post-surgical care protocols, with only the core surgical team aware of the specific intervention being applied. All study personnel involved in data collection, analysis, and patient follow-up will remain blinded until data lock
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 25, 2024
• Study Start: January 12, 2024
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 12, 2029
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

RU (1)