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Suture vs Mesh Repair for Incisional Hernia
N/A
Recruiting
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 5 years
Awards & highlights
Study Summary
This trial is comparing mesh and suture repairs for incisional hernias to see if one has a better quality of life at 1 year post-op.
Who is the study for?
Adults over 18 with a non-emergency incisional hernia measuring 2-6cm, who previously had ventral hernia repair without mesh. Not for those with prior mesh at the repair site, other wound classes, emergency cases, under 18s, pregnant individuals or hernias outside of the size range.Check my eligibility
What is being tested?
This study compares quality of life after one year in patients receiving incisional hernia repairs using either sutures alone or with mesh. It's a randomized trial to see if suture-only repair is just as good as mesh repair based on HerQLes scores.See study design
What are the potential side effects?
While not explicitly stated here, common side effects from such surgeries may include pain at the surgery site, infection risk, bleeding complications and potential for recurrence of the hernia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Complications
Cost effectiveness
Diaphragmatic Hernia
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Hernia repair with mesh (Control arm)Active Control1 Intervention
Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.
Group II: Primary closure (Intervention arm)Active Control1 Intervention
Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.
Find a Location
Who is running the clinical trial?
Clayton PetroLead Sponsor
4 Previous Clinical Trials
1,478 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,033 Previous Clinical Trials
1,365,230 Total Patients Enrolled
5 Trials studying Incisional Hernia
1,989 Patients Enrolled for Incisional Hernia
Clayton Petro, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hernia is between 2 and 6 cm wide.I am over 18 years old.I have an incisional hernia.I had surgery for a hernia in my abdomen without mesh.I have a primary hernia.My ventral hernia is either smaller than 2cm or larger than 6cm.I am under 18 years old.I had a mesh repair for a ventral hernia at the same spot before.My wound is classified between mild to severe infection risk.
Research Study Groups:
This trial has the following groups:- Group 1: Hernia repair with mesh (Control arm)
- Group 2: Primary closure (Intervention arm)
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.
How many participants are being admitted to this research effort?
"Affirmative. According to clinicaltrials.gov, this medical experiment has been open for recruitment since November 14th 2022 and was edited most recently on the 16th of that same month. The study is attempting to accept 154 participants at one location."
Answered by AI
Is this research endeavor still open for enrollment?
"Affirmative. Clinicaltrials.gov data suggests that this medical research is enlisting participants, with the initial posting of the trial being on November 14th 2022 and an update occurring two days later. A total of 154 patients will be accepted from a single location."
Answered by AI
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