NCT05974722 Mesh Vs Pledgets for Repair of Paraesophageal Hernia
| NCT ID | NCT05974722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | David Krpata |
| Condition | Paraesophageal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2023-09-11 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2023-09-11 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
David M Krpata, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT05974722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Paraesophageal Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05974722 currently recruiting?
Yes, NCT05974722 is actively recruiting participants. Contact the research team at krpatad@ccf.org for enrollment information.
Where is the NCT05974722 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05974722 clinical trial?
NCT05974722 is sponsored by David Krpata. The principal investigator is David M Krpata, MD at The Cleveland Clinic. The trial plans to enroll 164 participants.