A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to compare whether the use of Ovitex mesh provides superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions it aims to answer are: * Determine whether there is a difference in 2-year rates of radiographic recurrence with Ovitex versus pledgeted sutures in paraesophageal hernia repair. * Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets and mesh. A two-tailed research hypothesis will be used to determine whether there are differences between the two arms

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age or older

• Willing and able to provide informed consent

• Willing and able to participate in long-term follow up including study visits and surveys

• Type II, III, or IV hiatal hernia \> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively

Locations
United States
Ohio
Cleveland Clinic Center for Abdominal Core Health
RECRUITING
Cleveland
Contact Information
Primary
David M Krpata, MD
krpatad@ccf.org
216 445-3441
Backup
William C Bennett, MD
bennetw2@ccf.org
216 313-8971
Time Frame
Start Date: 2023-09-11
Estimated Completion Date: 2028-12
Participants
Target number of participants: 164
Treatments
Other: Mesh-based crural reinforcement
Patient will receive Ovitex mesh to reinforce the crural repair
Other: Pledgeted suture-based crural reinforcement
Patient will receive pledgeted sutures to reinforce the crural repair
Sponsors
Leads: David Krpata

This content was sourced from clinicaltrials.gov