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Procedure

Sugarbaker Technique vs Keyhole Technique for Parastomal Hernia Repair

N/A

Waitlist Available

Led By Clayton Petro, MD

Research Sponsored by Clayton Petro

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 1 week after the last surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two surgical methods using mesh to fix hernias around surgical openings in adults. One method drapes the mesh over the opening, and the other cuts a hole in it. Both aim to provide extra support and reduce the hernia coming back. The use of mesh in hernia repair, particularly around surgical openings, has shown promising results in reducing the hernia coming back.

Eligible Conditions

Parastomal Hernia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 1 week after the last surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of 1 week after the last surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 1 week after the last surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Radiographic hernia recurrence 2 years after parastomal hernia repair

Secondary study objectives

30-day complication rates

Hospital length-of-stay

Incidence of mesh-related complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: SugarbakerExperimental Treatment1 Intervention

For the Sugarbaker group, the bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially.

Group II: KeyholeExperimental Treatment1 Intervention

For the Keyhole group the stoma will be taken down and rematured through a cruciate incision (keyhole)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sugarbaker technique for repairing parastomal hernia

2019

N/A

~150

Keyhole technique for repairing parastomal hernia

2019

N/A

~150

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Who is running the clinical trial?

Clayton PetroLead Sponsor

4 Previous Clinical Trials

1,482 Total Patients Enrolled

The Cleveland ClinicLead Sponsor

1,052 Previous Clinical Trials

1,370,814 Total Patients Enrolled

2 Trials studying Parastomal Hernia

27 Patients Enrolled for Parastomal Hernia

Clayton Petro, MD5.02 ReviewsPrincipal Investigator - The Cleveland Clinic

The Cleveland Clinic

1 Previous Clinical Trials

154 Total Patients Enrolled

5Patient Review

I highly recommend this doctor. They saved my life and were extremely kind, listening to me the whole time with excellent bedside manner. They truly care.