Mesh Vs Pledgets for Repair of Paraesophageal Hernia

NCT05974722 | Recruiting FDA Device

• 1 other identifier: 22-1109
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Paraesophageal Hernia; GERD

Outcome Measures

Primary Outcomes (1)

• Radiographic recurrence rate

  The primary endpoint of this study is the binary 2-year rate of radiographic recurrence of the paraesophageal hernia, defined gastroesophageal junction at least 2 cm above the hiatus on upper gastrointestinal studies, CT, or MRI.

  2 years after surgery

Secondary Outcomes (12)

• Patient quality of life as measured by the validated EQ5D survey

  Preop, 30-day, 1-year, and 2-year timepoints after surgery

• Patient quality of life as measured by the validated EQ-VAS survey

  Preop, 30-day, 1-year, and 2-year timepoints after surgery

• Patient quality of life as measured by the validated decision regret scale survey

  1-year, and 2-year timepoints after surgery

• Patient quality of life as measured by the GERD-HRQL scale

  Preop, 30-day, 1-year, and 2-year timepoints after surgery

• Patient satisfaction as measured by patient reported assessment

  Preop, 30-day, 1-year, and 2-year timepoints after surgery

Study Arms (2)

Mesh-based crural reinforcement

OTHER

Patient will receive Ovitex mesh to reinforce the crural repair

Device: OviTex Mesh

Pledgeted suture-based crural reinforcement

OTHER

Patient will receive pledgeted sutures to reinforce the crural repair

Other: Pledgeted sutures

Interventions

OviTex Mesh DEVICE

Patient will receive Ovitex Mesh (TELA Bio)

Mesh-based crural reinforcement

Pledgeted sutures OTHER

Patient will receive pledgeted sutures

Pledgeted suture-based crural reinforcement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Krpata: lead

Study Sites (1)

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Hernia, Hiatal; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• David M Krpata, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David M Krpata, MD

CONTACT

216 445-3441; krpatad@ccf.org

William C Bennett, MD

CONTACT

216 313-8971; bennetw2@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients will be blinded to the intervention. Additionally, there will be blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery, CCF Lerner College of Medicine

Model Details: Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair

Study Record Dates

• First Submitted: July 15, 2023
• First Posted: August 3, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)