RECRUITING

Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-09-11
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05974722

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * Willing and able to provide informed consent
  3. * Willing and able to participate in long-term follow up including study visits and surveys
  4. * Type II, III, or IV hiatal hernia \> 5 cm, confirmed via upper GI studies, CT, or MRI 5 cm or greater hernia confirmed intraoperatively
  1. * Pregnancy
  2. * BMI \>45
  3. * Allergy to any components of mesh
  4. * 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)
  5. * Patients who have undergone previous hiatal hernia repair

Contacts and Locations

Study Contact

Michael J Rosen, MD
CONTACT
216 445-3441
rosenm@ccf.org
Ryan C Ellis, MD
CONTACT
440 409-3948
ellisr2@ccf.org

Principal Investigator

Michael J Rosen, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Michael Rosen

  • Michael J Rosen, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11
Study Completion Date2027-09

Study Record Updates

Study Start Date2023-09-11
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Paraesophageal Hernia
  • GERD