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Clinical Trials/NCT04440514
NCT04440514
Recruiting
Not Applicable

Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)

Sykehuset Innlandet HF2 sites in 1 country150 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parastomal Hernia
Sponsor
Sykehuset Innlandet HF
Enrollment
150
Locations
2
Primary Endpoint
Adverse events
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
June 2035
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • parastomal hernia with need of repair

Exclusion Criteria

  • \< 18 years

Outcomes

Primary Outcomes

Adverse events

Time Frame: 1 month

Per- and post-operative complications

Secondary Outcomes

  • Late complications(2 years)
  • Recurrence of hernia(2 years)

Study Sites (2)

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