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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
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Suture repair for incisional hernia involves mechanically closing the hernia defect using sutures, relying on the strength of the tissue and sutures to maintain closure. Mesh repair involves placing a synthetic or biological mesh over or under the hernia defect to reinforce the area, acting as a scaffold that integrates with the surrounding tissue to provide additional strength and reduce recurrence risk.
Understanding these mechanisms helps patients and doctors make informed decisions about which treatment may offer better long-term outcomes and lower recurrence rates.
Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate?A systematic review on surgical treatment of primary epigastric hernias.Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial.
Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate?A systematic review on surgical treatment of primary epigastric hernias.Prophylactic biological mesh reinforcement versus standard closure of stoma site (ROCSS): a multicentre, randomised controlled trial.
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
1,037 Previous Clinical Trials
1,366,857 Total Patients Enrolled
5 Trials studying Incisional Hernia
1,984 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.
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