Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Krpata
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- OviTex Mesh
- Pledgeted sutures
Treatment groups
164 Participants
are divided into 2 treatment groupsSponsors and collaborators
David Krpata
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov