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.