Actively Recruiting

All Genders
ID04440514

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Led by Sykehuset Innlandet HF · Updated on 2023-03-09

150

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on parastomal hernia repair using endoscopic methods. It evaluates laparoscopic and robotic extraperitoneal mesh repair techniques that include transversus abdominis release (TAR) and mesh reinforcement following the Sugarbaker principle. The study aims to assess these surgical approaches and their outcomes over time. The repair involves an endoscopic trans-abdominal preperitoneal plasty (TAPP) method placing mesh extraabdominally, anterior to the transversalis fascia. Both laparoscopic and robotic procedures are used, with additional repair of any midline hernias through an enhanced-view Rives-Stoppa technique. This approach is studied for safety and effectiveness in reinforcing hernia repair. Participants will be monitored for adverse events within one month after the procedure, with further follow-up over two years to observe late complications and hernia recurrence. The study collects data through clinical evaluations during this period. Participation duration varies with follow-up assessments scheduled up to two years after surgery to ensure comprehensive monitoring of outcomes.

CONDITIONS

Brief Title

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Parastomal hernia with need of repair
  • Participants aged 18 years or older
Not Eligible

You will not qualify if you...

  • Under 18 years of age

AI-Screening

AI-Powered 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 and Immediate Post-operative Care

Duration - Up to 1 week or until discharge

Participants undergo endoscopic preperitoneal repair of parastomal hernia with mesh reinforcement, followed by immediate post-operative care.

1 surgical procedure and hospital stay

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored for adverse events and late complications after surgery.

Approximately 6 post-operative visits

Trial Site Locations

Total: 2 locations

1

Sykehuset Innlandet Hospital Trust

Brumunddal, Norway, 2380

Enrolling by Invitation

2

Sykehuset Innlandet HF

Hamar, Norway

Actively Recruiting

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Research Team

J

jan r lambrecht, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study.

Thomas Gavigan, Thomas Stewart, Brent Matthews...

https://pubmed.ncbi.nlm.nih.gov/30081081

Surgical techniques for parastomal hernia repair: a systematic review of the literature.

Birgitta M E Hansson, Nicholas J Slater, Arjan Schouten van der Velden...

https://pubmed.ncbi.nlm.nih.gov/22418006

Posterior Component Separation with Transversus Abdominis Release: Technique, Utility, and Outcomes in Complex Abdominal Wall Reconstruction.

Christine M Jones, Joshua S Winder, John D Potochny...

https://pubmed.ncbi.nlm.nih.gov/26818302

Laparoscopic parastomal herniorrhaphy utilizing transversus abdominis release and a modified Sugarbaker technique: A case report.

Kiyotaka Imamura, Minoru Takada, Kazufumi Umemoto...

https://pubmed.ncbi.nlm.nih.gov/32495518