Paraesophageal HerniaNCT05974722
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
A study testing OviTex Mesh and Pledgeted sutures in people with Paraesophageal Hernia and GERD, run by David Krpata at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraesophageal Hernia, GERD
- What is being tested?
- OviTex Mesh and Pledgeted sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Center for Abdominal Core Health
Cleveland, Ohio, 44195
Michael J Rosen, MD, 216-445-3441, rosenm@ccf.org
About this study
Official title: A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
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
Read the 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.
- Conditions
- Paraesophageal Hernia, GERD
- Being tested
- OviTex Mesh, Pledgeted sutures
- Medical subject headings
- Hernia, Hiatal, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OviTex MeshDevice
Patient will receive Ovitex Mesh (TELA Bio)
Pledgeted suturesOther
Patient will receive pledgeted sutures
| Study group | Role | What they receive |
|---|---|---|
| Mesh-based crural reinforcement | Other | Patient will receive Ovitex mesh to reinforce the crural repair Receives: Device: OviTex Mesh |
| Pledgeted suture-based crural reinforcement | Other | Patient will receive pledgeted sutures to reinforce the crural repair Receives: Other: Pledgeted sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years after surgery
Secondary outcomes (12)
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.
Measured: Preop, 30-day, 1-year, and 2-year timepoints after surgery
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.
Measured: Preop, 30-day, 1-year, and 2-year timepoints after surgery
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.
Measured: 1-year, and 2-year timepoints after surgery
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.
Measured: Preop, 30-day, 1-year, and 2-year timepoints after surgery
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.
Measured: Preop, 30-day, 1-year, and 2-year timepoints after surgery
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.
Measured: Preop, 30-day, 1-year, and 2-year timepoints after surgery
Immediate recurrence
The rates of immediate paraesophageal recurrence (as defined as within 45 days of surgery) will be compared between the 2 groups.
Measured: Within 45 days from surgery
Reoperations
Reoperation rates for paraesophageal hernia will be compared between the two groups throughout the study
Measured: Throughout study up to 2 years after surgery
Intraoperative complications
Intraoperative complications (solid organ injury, etc.) will be recorded and compared between the two groups.
Measured: At time of surgery
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.
Measured: Throughout study up to 2 years after surgery
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).
Measured: Throughout study up to 2 years after surgery
Foregut complications requiring reintervention
Foregut complications requiring reinterventions will be recorded for each patient and compared between the two groups.
Measured: Throughout study up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start11 Sep 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraesophageal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Krpata
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Krpata, The Cleveland Clinic
- Investigators
- David M Krpata, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974722
- Sponsor's protocol ID
- 22-1109
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence
- ClinicalTrials.gov ID
- NCT05974722
- Acronym / sponsor ID
- 22-1109
- Conditions
- Paraesophageal Hernia, GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- David KrpataUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair
| Arm | Type | Receives |
|---|---|---|
| Mesh-based crural reinforcement | Other | Device: OviTex MeshPatient will receive Ovitex mesh to reinforce the crural repair |
| Pledgeted suture-based crural reinforcement | Other | Other: Pledgeted suturesPatient will receive pledgeted sutures to reinforce the crural repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OviTex MeshPatient will receive Ovitex Mesh (TELA Bio) | Device | Mesh-based crural reinforcement |
| Pledgeted suturesPatient will receive pledgeted sutures | Other | Pledgeted suture-based crural reinforcement |
Primary outcome
Radiographic recurrence rate
Time frame: 2 years after surgery
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.
12 secondary outcomes
Patient quality of life as measured by the validated EQ5D survey
Time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
Patient quality of life as measured by the validated EQ-VAS survey
Time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
Patient quality of life as measured by the validated decision regret scale survey
Time frame: 1-year, and 2-year timepoints after surgery
Patient quality of life as measured by the GERD-HRQL scale
Time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
Patient satisfaction as measured by patient reported assessment
Time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
Patient quality of life as measured by presence of patient reported dysphagia symptoms
Time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
Immediate recurrence
Time frame: Within 45 days from surgery
Reoperations
Time frame: Throughout study up to 2 years after surgery
Intraoperative complications
Time frame: At time of surgery
Clavien-Dindo Complications
Time frame: Throughout study up to 2 years after surgery
Comprehensive Complications Index (CCI)
Time frame: Throughout study up to 2 years after surgery
Foregut complications requiring reintervention
Time frame: Throughout study up to 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Laparoscopic Nissen Versus Toupet Fundoplication for Hiatal Hernia.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David M Krpata, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OviTex Mesh and Pledgeted sutures in people with Paraesophageal Hernia and GERD, run by David Krpata at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David M Krpata, MD (216 445-3441, krpatad@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic recurrence rate (time frame: 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.