Clinical trial NCT05974722: Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Official title: A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paraesophageal Hernia
GERD
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair
Primary purpose: PREVENTION

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

Detailed 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.

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

Primary outcomes:
measure: Radiographic recurrence rate
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Patient quality of life as measured by the validated EQ5D survey
timeFrame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
measure: Patient quality of life as measured by the validated EQ-VAS survey
timeFrame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
measure: Patient quality of life as measured by the validated decision regret scale survey
timeFrame: 1-year, and 2-year timepoints after surgery
measure: Patient quality of life as measured by the GERD-HRQL scale
timeFrame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
measure: Patient satisfaction as measured by patient reported assessment
timeFrame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
measure: Patient quality of life as measured by presence of patient reported dysphagia symptoms
timeFrame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
measure: Immediate recurrence
timeFrame: Within 45 days from surgery
measure: Reoperations
timeFrame: Throughout study up to 2 years after surgery
measure: Intraoperative complications
timeFrame: At time of surgery
measure: Clavien-Dindo Complications
timeFrame: Throughout study up to 2 years after surgery
measure: Comprehensive Complications Index (CCI)
timeFrame: Throughout study up to 2 years after surgery
measure: Foregut complications requiring reintervention
timeFrame: Throughout study up to 2 years after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Center for Abdominal Core Health
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael J Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References: