Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Description

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

Conditions

Paraesophageal Hernia, GERD

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Study Overview

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Study Details

Study overview

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

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

Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Condition
Paraesophageal Hernia
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Center for Abdominal Core Health, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Pregnancy
  • * BMI \>45
  • * Allergy to any components of mesh
  • * Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch, single-anastomosis gastric bypass, and partial or total gastrectomy)
  • * Patients who have undergone previous hiatal hernia repair

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Michael Rosen,

Michael J Rosen, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2027-09