Fascial closure for Parastomal Hernia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic Foundation, Cleveland, OH
Parastomal Hernia+1 More
closure of parastomal hernia fascial defect - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Parastomal Hernia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Parastomal Hernia

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 2 years

1 year
Stoma specific quality of life score (1 year)
2 years
Abdominal Wall Specific Quality of Life
Decision Regret
Pain Intensity
Recurrence
Stoma specific quality of life score (2 years)
30 days
Ileus
Length of stay
Opioid consumption
Stoma specific quality of life score (30 days)
Wound morbidity

Trial Safety

Safety Progress

1 of 3

Other trials for Parastomal Hernia

Trial Design

2 Treatment Groups

Fascial closure
1 of 2
No fascial closure
1 of 2
Active Control

50 Total Participants · 2 Treatment Groups

Primary Treatment: Fascial closure · No Placebo Group · N/A

Fascial closure
Procedure
ActiveComparator Group · 1 Intervention: closure of parastomal hernia fascial defect · Intervention Types: Procedure
No fascial closureNoIntervention Group · 1 Intervention: No fascial closure · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Closest Location: Cleveland Clinic Foundation · Cleveland, OH
Photo of Cleveland 1Photo of Cleveland 2Photo of Cleveland 3
2007First Recorded Clinical Trial
1 TrialsResearching Parastomal Hernia
578 CompletedClinical Trials

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
929 Previous Clinical Trials
1,388,871 Total Patients Enrolled
1 Trials studying Parastomal Hernia
150 Patients Enrolled for Parastomal Hernia

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The defect should not exceed 7 cm in any direction.
You must be at least 18 years old to participate in this study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.