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Procedure

Mesh vs Pledgets for Hernia Repair

N/A
Recruiting
Led By Michael J Rosen, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year, and 2-year timepoints after surgery
Awards & highlights

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Radiographic recurrence rate
Secondary outcome measures
Clavien-Dindo Complications
Comprehensive Complications Index (CCI)
Foregut complications requiring reintervention
+9 more

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?

The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,365,394 Total Patients Enrolled
1 Trials studying Paraesophageal Hernia
240 Patients Enrolled for Paraesophageal Hernia
Michael J Rosen, MDPrincipal InvestigatorThe Cleveland Clinic
4 Previous Clinical Trials
582 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots remaining for this clinical experiment?

"According to clinicaltrials.gov, this study is not actively recruiting individuals at the moment; it was first posted on August 1st 2023 and last modified on July 26th 2023. Even though there are currently no recruitment opportunities for this trial, over one hundred eighty-seven other experiments require volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Michael Rosen 2023. "Mesh Vs Pledgets for Repair of Paraesophageal Hernia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05974722.
All > Hernia
~109 spots leftby Aug 2025
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