MedTrace Logo

Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair

NCT05514600 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-07-19

No results posted yet for this study

Summary

Fascial closure was not originally a routine component of minimally invasive parastomal hernia repairs, but several recent advancements have made fascial closure more common in this context. These include barbed self-locking sutures that aid intracorporeal fascial closure under tension, and wristed instrumentation offered by the robotic platform when available. The investigator aims to characterize the clinical significance of closing the fascia adjacent to the stoma during a MIS parastomal hernia repair.

The investigator hypothesizes that fascial closure will not have a significant impact on postoperative stoma specific quality of life but will reduce long-term recurrence.

Conditions

  • Parastomal Hernia

Interventions

PROCEDURE

closure of parastomal hernia fascial defect

For subjects randomized to the fascial closure arm, the parastomal defect will be closed using barbed, running suture prior to placement of the mesh.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-08
Primary Completion
2023-05-20
Completion
2023-05-20

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05514600 on ClinicalTrials.gov