Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06474403

Laparoscopic Total Extraperitoneal Parastomal Hernia Repair as a Modification of Sugabecker's Operation

Led by State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital · Updated on 2026-01-21

50

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Parastomal hernia is a common complication following stoma surgery that poses significant challenges due to high recurrence rates and impacts patient quality of life. This research investigates a laparoscopic total extraperitoneal (TEP) technique as a modification of the traditional Sugabecker's operation. The study aims to assess the feasibility, safety, and recurrence rates of this minimally invasive approach compared to standard methods. The study involves two groups of patients with parastomal hernias: one receiving the traditional Sugarbaker procedure with intraperitoneal onlay mesh (IPOM) placement, and the other undergoing the modified laparoscopic TEP repair where mesh is placed entirely in the extraperitoneal space. The laparoscopic TEP method includes a unilateral transrectal incision and creation of a preperitoneal or retro-rectus space to position the mesh. This approach is expected to reduce operative trauma and complications compared to the open method. Participants will be monitored for intraoperative complications, postoperative pain, infectious complications, length of hospital stay, and hernia recurrence over a follow-up period of up to one year. Quality of life will be assessed using the SF-36 survey at multiple time points. Early mobilization and recovery will be encouraged, with routine activities expected to resume within two weeks. The primary outcome is the hernia recurrence rate at one year post-operation, along with secondary measures including infection rates, pain levels, hospital stay length, and quality of life improvements.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with a confirmed diagnosis of parastomal hernia after stoma surgery
  • Symptomatic hernias that require surgical repair
  • Able to undergo surgery under general anesthesia
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to laparoscopic surgery, including uncontrolled bleeding disorders, severe heart or lung conditions, or extensive abdominal adhesions
  • Ongoing peritonitis or incarcerated hernias requiring urgent care
  • Malignancy at the hernia site
  • Unwillingness to provide informed consent
  • Life expectancy shorter than the study follow-up period
  • Previous hernia repairs that may affect study outcomes

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - 1 day

Participants undergo parastomal hernia repair surgery through either the standard Sugarbecker's operation or the modified laparoscopic total extraperitoneal (TEP) approach.

1 surgery visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 30 days

Participants receive immediate post-operative care including management of pain and monitoring for complications such as infections or hematoma.

Daily assessments during hospital stay and visits at post-operative days 1, 3, 7, and 14

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored for surgical site infections, hernia recurrence, quality of life, and recovery progress over time.

Visits at 1 month, 3 months, 6 months, 1 year, and 2 years post-operation

Trial Site Locations

Total: 1 location

1

S.V. Ochapovsky Regional Clinical Hospital #1

Krasnodar, Russia, 350040

Actively Recruiting

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Research Team

A

Aleksandr Petrovsky, MD, PhD

V

Vadim Polovinkin, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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