Mesh Vs Pledgets for Repair of Paraesophageal Hernia

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
David Krpata
Study ID
NCT05974722
Status
Recruiting
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Conditions

  • GERD
  • Paraesophageal Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OviTex Mesh — DEVICE
    Patient will receive Ovitex Mesh (TELA Bio)
  • Pledgeted sutures — OTHER
    Patient will receive pledgeted sutures

Study Details

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

Key Dates

Start date
Sep 11, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Center for Abdominal Core HealthClevelandOhio44195
Michael J Rosen, MD
[email protected]
216 445-3441

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Center for Abdominal Core Health· Cleveland, OH

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