Mesh Vs Pledgets for Repair of Paraesophageal Hernia

NCT ID: NCT05974722

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-11
• Study Completion Date: 2028-12-31

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

Detailed Description

This is a prospective, single-center, randomized, two-arm trial assessing the impact of Ovitex mesh on paraesophageal hernia recurrence. This study will occur at Cleveland Clinic Foundation in Cleveland, OH. A total of 164 patients will be enrolled in this study. The anticipated accrual rate is approximately 7 per month for a total accrual period of approximately 24 months.

Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met as specified in Section 4. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1 month (10 days-45 days) and annually through 2 years postoperatively. Total estimated duration for the trial is 4 years for the primary outcome with an additional 3 years for longer term follow up resulting in a total of 7 years.

Several approaches to limiting bias are included in this trial.

• Intraoperative bias- limited by randomization just prior to crural closure
• Blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging
• Single blind - patients blinded to intervention Devices included in this study include Ovitex mesh and pledgets which are both used to reinforce the repair at the crura. Ovitex mesh is FDA approved for this indication.

Study Endpoints Primary Endpoint 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 GI studies, CT, or MRI. Anatomical recurrence assessed via imaging is the gold standard of diagnosing recurrence, and thus is the most appropriate primary outcome.

Secondary Endpoints

• Patient quality of life (measured at baseline, 30 days, and annually)

• EQ5D
• EQ-VAS
• Decision regret index (only measured annually)
• GERD-HRQL
• Presence of regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms
• Immediate recurrence rates (within 45 days of surgery)
• Reoperation rates throughout the study
• Cost
• Safety endpoints:

• Intraoperative complications: solid organ injury, etc.
• Clavien-Dindo complications
• Comprehensive Complications Index
• Foregut complications requiring re-interventions

While anatomic recurrence is extremely important from a surgical perspective, patients often have variable impacts of recurrence on quality of life. Furthermore, there is significant variability in symptoms for patients with recurrence. These secondary outcomes will help us to characterize the impact of potential recurrences on the patient.

Additionally, immediate recurrences offer insight into possible issues with the repair and are important to evaluate. Rates of reoperation can indicate the severity of the recurrence's impact on quality of life. Given the concerns about mesh complications, safety endpoints are necessary. Since the use of mesh is more expensive than not using mesh, collecting data on cost will help in future cost effectiveness analyses.

Conditions

Paraesophageal Hernia; GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Mesh-based crural reinforcement

Patient will receive Ovitex mesh to reinforce the crural repair

Group Type: OTHER

OviTex Mesh

Intervention Type: DEVICE

Patient will receive Ovitex Mesh (TELA Bio)

Pledgeted suture-based crural reinforcement

Patient will receive pledgeted sutures to reinforce the crural repair

Group Type: OTHER

Pledgeted sutures

Intervention Type: OTHER

Patient will receive pledgeted sutures

Interventions

OviTex Mesh

Patient will receive Ovitex Mesh (TELA Bio)

Intervention Type: DEVICE

Pledgeted sutures

Patient will receive pledgeted sutures

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

David Krpata

OTHER

Sponsor Role: lead

Responsible Party

David Krpata

Professor of Surgery, CCF Lerner College of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David M Krpata, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Center for Abdominal Core Health

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David M Krpata, MD

Role: CONTACT

krpatad@ccf.org

216 445-3441

William C Bennett, MD

Role: CONTACT

bennetw2@ccf.org

216 313-8971

Facility Contacts

Michael J Rosen, MD

Role: primary

rosenm@ccf.org

216 445-3441

Other Identifiers

22-1109

Identifier Type: -

Identifier Source: org_study_id