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Suture vs Mesh Repair for Incisional Hernia

N/A
Recruiting
Led By Clayton Petro, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults >18 years old.
Anticipated hernia defect 2-6cm in width
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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My hernia is between 2 and 6 cm wide.
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I had surgery for a hernia in my abdomen without mesh.
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I have an incisional hernia.
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My hernia is expected to be between 2 and 6 cm wide.
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I had surgery for a hernia in my abdomen without mesh.
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I have an incisional hernia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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?

The Cleveland ClinicLead Sponsor
1,014 Previous Clinical Trials
1,364,378 Total Patients Enrolled
4 Trials studying Incisional Hernia
493 Patients Enrolled for Incisional Hernia
Clayton Petro, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Incisional hernia repair (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05599750 — N/A
Incisional Hernia Research Study Groups: Hernia repair with mesh (Control arm), Primary closure (Intervention arm)
Incisional Hernia Clinical Trial 2023: Incisional hernia repair Highlights & Side Effects. Trial Name: NCT05599750 — N/A
Incisional hernia repair (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05599750 — N/A

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
~49 spots leftby Oct 2024