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Procedure

Mesh vs Pledgets for Hernia Repair

N/A
Recruiting
Led By Michael J Rosen, MD
Research Sponsored by Michael Rosen
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 1-year, and 2-year timepoints after surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial examines whether using mesh during a paraesophageal hernia repair surgery improves results and patient quality of life compared to using sutures alone.

Who is the study for?
This trial is for adults who can consent and participate in long-term follow-up, with a Type II, III, or IV hiatal hernia larger than 5 cm. It's not for individuals with a BMI over 45, those who've had previous hernia repairs, are pregnant, allergic to mesh materials or undergoing stomach volume reduction procedures.
What is being tested?
The study compares Ovitex mesh use against pledgeted sutures in paraesophageal hernia repair regarding their effect on the recurrence rate after two years and patient quality of life post-surgery at Cleveland Clinic.
What are the potential side effects?
While specific side effects aren't listed here, generally surgical interventions like these may include pain at the surgery site, infection risk, reaction to materials used (like mesh), and potential complications related to hernia repair.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year, and 2-year timepoints after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year, and 2-year timepoints after 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 recurrence rate
Secondary study objectives
Clavien-Dindo Complications
Comprehensive Complications Index (CCI)
Foregut complications requiring reintervention
+9 more

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: Pledgeted suture-based crural reinforcementExperimental Treatment1 Intervention
Patient will receive pledgeted sutures to reinforce the crural repair
Group II: Mesh-based crural reinforcementExperimental Treatment1 Intervention
Patient will receive Ovitex mesh to reinforce the crural repair

Find a Location

Who is running the clinical trial?

Michael RosenLead Sponsor
2 Previous Clinical Trials
353 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,051 Previous Clinical Trials
1,370,728 Total Patients Enrolled
Michael J Rosen, MDPrincipal InvestigatorThe Cleveland Clinic
4 Previous Clinical Trials
582 Total Patients Enrolled
~60 spots leftby Aug 2025
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