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Mesh Vs Pledgets for Repair of Paraesophageal Hernia Repair

Primary Purpose

Paraesophageal Hernia, GERD

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OviTex Mesh
Pledgeted sutures
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Paraesophageal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Center for Abdominal Core HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Mesh-based crural reinforcement

Pledgeted suture-based crural reinforcement

Arm Description

Patient will receive Ovitex mesh to reinforce the crural repair

Patient will receive pledgeted sutures to reinforce the crural repair

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Immediate recurrence
The rates of immediate paraesophageal recurrence (as defined as within 45 days of surgery) will be compared between the 2 groups.
Reoperations
Reoperation rates for paraesophageal hernia will be compared between the two groups throughout the study
Intraoperative complications
Intraoperative complications (solid organ injury, etc.) will be recorded and compared between the two groups.
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.
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).
Foregut complications requiring reintervention
Foregut complications requiring reinterventions will be recorded for each patient and compared between the two groups.

Full Information

First Posted
July 15, 2023
Last Updated
October 18, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05974722
Brief Title
Mesh Vs Pledgets for Repair of Paraesophageal Hernia Repair
Official Title
A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraesophageal Hernia, GERD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair
Masking
ParticipantCare Provider
Masking Description
Patients will be blinded to the intervention. Additionally, there will be blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesh-based crural reinforcement
Arm Type
Other
Arm Description
Patient will receive Ovitex mesh to reinforce the crural repair
Arm Title
Pledgeted suture-based crural reinforcement
Arm Type
Other
Arm Description
Patient will receive pledgeted sutures to reinforce the crural repair
Intervention Type
Device
Intervention Name(s)
OviTex Mesh
Intervention Description
Patient will receive Ovitex Mesh (TELA Bio)
Intervention Type
Other
Intervention Name(s)
Pledgeted sutures
Intervention Description
Patient will receive pledgeted sutures
Primary Outcome Measure Information:
Title
Radiographic recurrence rate
Description
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 surgery
Secondary Outcome Measure Information:
Title
Patient quality of life as measured by the validated EQ5D survey
Description
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 surgery
Title
Patient quality of life as measured by the validated EQ-VAS survey
Description
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 surgery
Title
Patient quality of life as measured by the validated decision regret scale survey
Description
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 surgery
Title
Patient quality of life as measured by the GERD-HRQL scale
Description
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 surgery
Title
Patient satisfaction as measured by patient reported assessment
Description
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.
Time Frame
Preop, 30-day, 1-year, and 2-year timepoints after surgery
Title
Patient quality of life as measured by presence of patient reported dysphagia symptoms
Description
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.
Time Frame
Preop, 30-day, 1-year, and 2-year timepoints after surgery
Title
Immediate recurrence
Description
The rates of immediate paraesophageal recurrence (as defined as within 45 days of surgery) will be compared between the 2 groups.
Time Frame
Within 45 days from surgery
Title
Reoperations
Description
Reoperation rates for paraesophageal hernia will be compared between the two groups throughout the study
Time Frame
Throughout study up to 2 years after surgery
Title
Intraoperative complications
Description
Intraoperative complications (solid organ injury, etc.) will be recorded and compared between the two groups.
Time Frame
At time of surgery
Title
Clavien-Dindo Complications
Description
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.
Time Frame
Throughout study up to 2 years after surgery
Title
Comprehensive Complications Index (CCI)
Description
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).
Time Frame
Throughout study up to 2 years after surgery
Title
Foregut complications requiring reintervention
Description
Foregut complications requiring reinterventions will be recorded for each patient and compared between the two groups.
Time Frame
Throughout study up to 2 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael J Rosen, MD
Phone
216 445-3441
Email
rosenm@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan C Ellis, MD
Phone
440 409-3948
Email
ellisr2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Rosen, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Center for Abdominal Core Health
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Rosen, MD
Phone
216-445-3441
Email
rosenm@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mesh Vs Pledgets for Repair of Paraesophageal Hernia Repair

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