Recruiting

Mesh vs. Pledgets

Sponsor:

David Krpata

Code:

NCT05974722

Conditions

Paraesophageal Hernia

GERD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OviTex Mesh

Pledgeted sutures

Study Details

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

Study ID

NCT05974722

Start date

Sep 11, 2023

Status verified date

Jul, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

Interventions

OviTex Mesh

Patient will receive Ovitex Mesh (TELA Bio)

Pledgeted sutures

Patient will receive pledgeted sutures

Primary outcome measure

  • Radiographic recurrence rate [ Time Frame: 2 years after surgery ]

Central Contacts and Locations

Central contacts

David M Krpata, MD

216 445-3441krpatad@ccf.org

William C Bennett, MD

216 313-8971bennetw2@ccf.org

Locations

Cleveland Clinic Center for Abdominal Core Health

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Michael J Rosen, MD

216 445-3441rosenm@ccf.org

More Information

Sponsor

David Krpata

Last update posted

Oct 7, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Krpata on 2025-10-07.