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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05974722
Other study ID # 22-1109
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date September 2027

Study information

Verified date December 2023
Source The Cleveland Clinic
Contact Michael J Rosen, MD
Phone 216 445-3441
Email rosenm@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
OviTex Mesh
Patient will receive Ovitex Mesh (TELA Bio)
Other:
Pledgeted sutures
Patient will receive pledgeted sutures

Locations

Country Name City State
United States Cleveland Clinic Center for Abdominal Core Health Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic recurrence rate 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 gastrointestinal studies, CT, or MRI. 2 years after surgery
Secondary Patient quality of life as measured by the validated EQ5D survey Patient quality of life will be assessed using the validated EQ5D (EuroQol 5 Dimension) survey measuring self-reported assessments of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression between the two groups. Preop, 30-day, 1-year, and 2-year timepoints after surgery
Secondary Patient quality of life as measured by the validated EQ-VAS survey Patient quality of life will be assessed using the validated EQ-VAS (EuroQol Visual Analog Scale) that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health attributed by paraesophageal hernias and compared between the two groups. This scale was designed to be used in conjunction with the EQ5D survey. Preop, 30-day, 1-year, and 2-year timepoints after surgery
Secondary Patient quality of life as measured by the validated decision regret scale survey Patient quality of life will be assessed using the validated decision regret scale, a 5-item survey used to serve as an indicator of health care decision regret at a given point in time attributed by undergoing surgery for the patient's paraesophageal hernia and compared between the two groups. The patients are asked 5 questions regarding the decision to undergo the surgery and to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. To obtain a final score, the items are converted to a 0-100 scale by subtracting 1 from each item then multiplying by 25. A score of 0 means no regret; a score of 100 means high regret. Final scores will be compared between the two groups. 1-year, and 2-year timepoints after surgery
Secondary Patient quality of life as measured by the GERD-HRQL scale Patient quality of life will be assessed using the validated GERD-HRQL (GastroEsophageal Reflux Disease Health-Related Quality of Life) scale, which provides a quantitative method of measuring GERD symptoms severity and contains a total of 10 scaled items (Likert 0-5, with higher score indicating worse symptoms). A minimum composite score of 0 will be the best possible score (asymptomatic in all items) and the maximum score of 50 represents incapacitation in all items. Composite scores will be compared between the two groups. Preop, 30-day, 1-year, and 2-year timepoints after surgery
Secondary Patient satisfaction as measured by patient reported assessment Patient-reported global satisfaction assessment within the GERD-HRQL (GastroEsophageal Reflux Disease Health-Related Quality of Life) survey. The patient will answer whether they are satisfied, neutral, or dissatisfied with their present condition at the time of completing the GERD-HRQL. Their answers will be interpreted as a patient-reported 'global' assessment of their condition with respect to GERD and compared between the two groups. Preop, 30-day, 1-year, and 2-year timepoints after surgery
Secondary Patient quality of life as measured by presence of patient reported dysphagia symptoms A dysphagia scale will be used to measure the presence of 8 symptoms (regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular, and pulmonary symptoms) over the prior 7 days, each on a 0-10 scale with 0 representing "no effect on life" and 10 representing "extreme effect on life." Mean scores for each symptom will be compared between the two groups. Preop, 30-day, 1-year, and 2-year timepoints after surgery
Secondary Immediate recurrence The rates of immediate paraesophageal recurrence (as defined as within 45 days of surgery) will be compared between the 2 groups. Within 45 days from surgery
Secondary Reoperations Reoperation rates for paraesophageal hernia will be compared between the two groups throughout the study Throughout study up to 2 years after surgery
Secondary Intraoperative complications Intraoperative complications (solid organ injury, etc.) will be recorded and compared between the two groups. At time of surgery
Secondary Clavien-Dindo Complications The Clavien-Dindo complication classification, which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb, and V) where higher grades mean increased severity of complication, will be used to categorize complications for each patient and compared between the two groups. Throughout study up to 2 years after surgery
Secondary Comprehensive Complications Index (CCI) The Comprehensive Complications Index (CCI), which is calculated as the sum of all complications and weighted for their severity based on the Clavien-Dindo classification will be calculated for each patient and compared between the two groups. The CCI scale ranges from 0 (no complication) to 100 (death). Throughout study up to 2 years after surgery
Secondary Foregut complications requiring reintervention Foregut complications requiring reinterventions will be recorded for each patient and compared between the two groups. Throughout study up to 2 years after surgery
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