Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Recruiting

• Conditions: Parastomal Hernia

• Registration Number: NCT04440514
• Lead Sponsor: Sykehuset Innlandet HF

Brief Summary

Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal hernia, employing TAR.

Detailed Description

Endoscopic trans-abdominal preperitoneal plasty (TAPP) for parastomal hernia employing transversus abdominis release component separation (TAR) and reinforcement with mesh after the Sugarbaker principle, but placing mesh extraabdominally, anteriorly to the transversalis fascia. Laparoscopic and robotic procedures. Repair of concomitant midline hernia with endoscopic enhanced-view Rives-Stoppa technique.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-09
• Primary Completion: 2035-06
• Study Completion: 2035-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• parastomal hernia with need of repair

Exclusion Criteria

• < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	1 month	Per- and post-operative complications

Secondary Outcome Measures

Name	Time	Method
Late complications	2 years	Stoma function, pain, mesh complications
Recurrence of hernia	2 years	Hernia recurrence

Trial Locations

Locations (2)

Sykehuset Innlandet Hospital Trust; 🇳🇴 Brumunddal, Norway

Sykehuset Innlandet HF; 🇳🇴 Hamar, Norway