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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
OviTex Mesh
DevicePatient will receive Ovitex Mesh (TELA Bio)
Pledgeted sutures
Other interventionPatient will receive pledgeted sutures
Treatment groups
164 Participants
are divided into 2 treatment groupsGroup A: Mesh-based crural reinforcementOther 1 intervention
Group B: Pledgeted suture-based crural reinforcementOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 years after surgerySecondary outcomes
1
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.
Time frame
Preop, 30-day, 1-year, and 2-year timepoints after surgery2
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.
Time frame
Preop, 30-day, 1-year, and 2-year timepoints after surgery3
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.
Time frame
1-year, and 2-year timepoints after surgery4
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.
Time frame
Preop, 30-day, 1-year, and 2-year timepoints after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
David Krpata
Lead sponsor
The Cleveland Clinic
Sponsor institution
Source ClinicalTrials.gov