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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
Study Summary
This trial will compare two techniques for repairing hernias around a colostomy site, to see which one is more effective in preventing the hernia from 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic hernia recurrence 2 years after parastomal hernia repair
Secondary outcome measures
30-day complication rates
Hospital length-of-stay
Incidence of mesh-related complications
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
Find a Location
Who is running the clinical trial?
Clayton PetroLead Sponsor
4 Previous Clinical Trials
1,482 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,926 Total Patients Enrolled
1 Trials studying Parastomal Hernia
2 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.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a hernia near your stoma.You are willing to have a surgical procedure using a mesh for repair.You do not want to have a mesh-based repair for any reason.You are able to handle being under general anesthesia.
Research Study Groups:
This trial has the following groups:- Group 1: Sugarbaker
- Group 2: Keyhole
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently enrolling participants?
"As evidenced by the information available on clinicaltrials.gov, this trial is no longer looking for participants - it was initially posted in April 2019 and last updated in July 2022. However, there are still 159 other trials actively seeking out patients at present."
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