xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974722</url>
    </required_header>
    <id_info>
      <org_study_id>22-1109</org_study_id>
      <nct_id>NCT05974722</nct_id>
    </id_info>
    <brief_title>Mesh Vs Pledgets for Repair of Paraesophageal Hernia Repair</brief_title>
    <official_title>A Randomized, Blinded, Parallel-group Trial Evaluating Mesh Versus Pledgeted Sutures in Paraesophageal Hernia Recurrence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cleveland Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare whether the use of Ovitex mesh provides&#xD;
        superior reduction in 2-year recurrence compared to pledgeted suture closure (no mesh) for&#xD;
        patients undergoing paraesophageal hernia repair at the Cleveland Clinic. The main questions&#xD;
        it aims to answer are:&#xD;
  &#xD;
          -  Determine whether there is a difference in 2-year rates of radiographic recurrence with&#xD;
             Ovitex versus pledgeted sutures in paraesophageal hernia repair.&#xD;
  &#xD;
          -  Assess patient quality of life (QOL) after paraesophageal hernia repair with pledgets&#xD;
             and mesh. A two-tailed research hypothesis will be used to determine whether there are&#xD;
             differences between the two arms&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single-center, randomized, two-arm trial assessing the impact of&#xD;
        Ovitex mesh on paraesophageal hernia recurrence. This study will occur at Cleveland Clinic&#xD;
        Foundation in Cleveland, OH. A total of 164 patients will be enrolled in this study. The&#xD;
        anticipated accrual rate is approximately 7 per month for a total accrual period of&#xD;
        approximately 24 months.&#xD;
  &#xD;
        Patients may be enrolled into the study provided all inclusion and no exclusion criteria are&#xD;
        met as specified in Section 4. Subjects will be evaluated through hospital discharge and&#xD;
        return for follow-up visits at 1 month (10 days-45 days) and annually through 2 years&#xD;
        postoperatively. Total estimated duration for the trial is 4 years for the primary outcome&#xD;
        with an additional 3 years for longer term follow up resulting in a total of 7 years.&#xD;
  &#xD;
        Several approaches to limiting bias are included in this trial.&#xD;
  &#xD;
          -  Intraoperative bias- limited by randomization just prior to crural closure&#xD;
  &#xD;
          -  Blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging&#xD;
  &#xD;
          -  Single blind - patients blinded to intervention Devices included in this study include&#xD;
             Ovitex mesh and pledgets which are both used to reinforce the repair at the crura.&#xD;
             Ovitex mesh is FDA approved for this indication.&#xD;
  &#xD;
        Study Endpoints Primary Endpoint The primary endpoint of this study is the binary 2-year rate&#xD;
        of radiographic recurrence of the paraesophageal hernia, defined gastroesophageal junction at&#xD;
        least 2 cm above the hiatus on upper GI studies, CT, or MRI. Anatomical recurrence assessed&#xD;
        via imaging is the gold standard of diagnosing recurrence, and thus is the most appropriate&#xD;
        primary outcome.&#xD;
  &#xD;
        Secondary Endpoints&#xD;
  &#xD;
          -  Patient quality of life (measured at baseline, 30 days, and annually)&#xD;
  &#xD;
               -  EQ5D&#xD;
  &#xD;
               -  EQ-VAS&#xD;
  &#xD;
               -  Decision regret index (only measured annually)&#xD;
  &#xD;
               -  GERD-HRQL&#xD;
  &#xD;
               -  Presence of regurgitation, chest pain, abdominal pain, nausea, vomiting,&#xD;
                  postprandial pain, cardiovascular, and pulmonary symptoms&#xD;
  &#xD;
          -  Immediate recurrence rates (within 45 days of surgery)&#xD;
  &#xD;
          -  Reoperation rates throughout the study&#xD;
  &#xD;
          -  Cost&#xD;
  &#xD;
          -  Safety endpoints:&#xD;
  &#xD;
               -  Intraoperative complications: solid organ injury, etc.&#xD;
  &#xD;
               -  Clavien-Dindo complications&#xD;
  &#xD;
               -  Comprehensive Complications Index&#xD;
  &#xD;
               -  Foregut complications requiring re-interventions&#xD;
  &#xD;
        While anatomic recurrence is extremely important from a surgical perspective, patients often&#xD;
        have variable impacts of recurrence on quality of life. Furthermore, there is significant&#xD;
        variability in symptoms for patients with recurrence. These secondary outcomes will help us&#xD;
        to characterize the impact of potential recurrences on the patient.&#xD;
  &#xD;
        Additionally, immediate recurrences offer insight into possible issues with the repair and&#xD;
        are important to evaluate. Rates of reoperation can indicate the severity of the recurrence's&#xD;
        impact on quality of life. Given the concerns about mesh complications, safety endpoints are&#xD;
        necessary. Since the use of mesh is more expensive than not using mesh, collecting data on&#xD;
        cost will help in future cost effectiveness analyses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Patients will be blinded to the intervention. Additionally, there will be blinded outcome assessors/study team including 3 surgeons reviewing recurrence imaging</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Radiographic recurrence rate</measure>
      <time_frame>2 years after surgery</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life as measured by the validated EQ5D survey</measure>
      <time_frame>Preop, 30-day, 1-year, and 2-year timepoints after surgery</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life as measured by the validated EQ-VAS survey</measure>
      <time_frame>Preop, 30-day, 1-year, and 2-year timepoints after surgery</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life as measured by the validated decision regret scale survey</measure>
      <time_frame>1-year, and 2-year timepoints after surgery</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life as measured by the GERD-HRQL scale</measure>
      <time_frame>Preop, 30-day, 1-year, and 2-year timepoints after surgery</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction as measured by patient reported assessment</measure>
      <time_frame>Preop, 30-day, 1-year, and 2-year timepoints after surgery</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient quality of life as measured by presence of patient reported dysphagia symptoms</measure>
      <time_frame>Preop, 30-day, 1-year, and 2-year timepoints after surgery</time_frame>
      <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 &quot;no effect on life&quot; and 10 representing &quot;extreme effect on life.&quot; Mean scores for each symptom will be compared between the two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immediate recurrence</measure>
      <time_frame>Within 45 days from surgery</time_frame>
      <description>The rates of immediate paraesophageal recurrence (as defined as within 45 days of surgery) will be compared between the 2 groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reoperations</measure>
      <time_frame>Throughout study up to 2 years after surgery</time_frame>
      <description>Reoperation rates for paraesophageal hernia will be compared between the two groups throughout the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative complications</measure>
      <time_frame>At time of surgery</time_frame>
      <description>Intraoperative complications (solid organ injury, etc.) will be recorded and compared between the two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clavien-Dindo Complications</measure>
      <time_frame>Throughout study up to 2 years after surgery</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comprehensive Complications Index (CCI)</measure>
      <time_frame>Throughout study up to 2 years after surgery</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Foregut complications requiring reintervention</measure>
      <time_frame>Throughout study up to 2 years after surgery</time_frame>
      <description>Foregut complications requiring reinterventions will be recorded for each patient and compared between the two groups.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">164</enrollment>
    <condition>Paraesophageal Hernia</condition>
    <condition>GERD</condition>
    <arm_group>
      <arm_group_label>Mesh-based crural reinforcement</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patient will receive Ovitex mesh to reinforce the crural repair</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pledgeted suture-based crural reinforcement</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patient will receive pledgeted sutures to reinforce the crural repair</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>OviTex Mesh</intervention_name>
      <description>Patient will receive Ovitex Mesh (TELA Bio)</description>
      <arm_group_label>Mesh-based crural reinforcement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pledgeted sutures</intervention_name>
      <description>Patient will receive pledgeted sutures</description>
      <arm_group_label>Pledgeted suture-based crural reinforcement</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Willing and able to provide informed consent&#xD;
  &#xD;
            -  Willing and able to participate in long-term follow up including study visits and&#xD;
               surveys&#xD;
  &#xD;
            -  Type II, III, or IV hiatal hernia &gt; 5 cm, confirmed via upper GI studies, CT, or MRI 5&#xD;
               cm or greater hernia confirmed intraoperatively&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  BMI &gt;45&#xD;
  &#xD;
            -  Allergy to any components of mesh&#xD;
  &#xD;
            -  Patients undergoing PEHR with a concurrent bariatric procedure or other procedure to&#xD;
               reduce stomach volume (sleeve gastrectomy, roux-en-y gastric bypass, duodenal switch,&#xD;
               single-anastomosis gastric bypass, and partial or total gastrectomy)&#xD;
  &#xD;
            -  Patients who have undergone previous hiatal hernia repair&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael J Rosen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Michael J Rosen, MD</last_name>
      <phone>216 445-3441</phone>
      <email>rosenm@ccf.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ryan C Ellis, MD</last_name>
      <phone>440 409-3948</phone>
      <email>ellisr2@ccf.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cleveland Clinic Center for Abdominal Core Health</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Michael J Rosen, MD</last_name>
        <phone>216-445-3441</phone>
        <email>rosenm@ccf.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Michael Rosen</investigator_full_name>
      <investigator_title>Professor of Surgery, CCF Lerner College of Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Hernia, Hiatal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974722
  org study id: 22-1109
  nct id: NCT05974722
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  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
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized to receive mesh or pledgeted suture reinforcement of the crural repair
  primary purpose: Prevention
  masking: Double (Participant, Care 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
  measure: Radiographic recurrence rate
  time frame: 2 years after surgery
  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.
  measure: Patient quality of life as measured by the validated EQ5D survey
  time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
  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.
  measure: 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
  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.
  measure: Patient quality of life as measured by the validated decision regret scale survey
  time frame: 1-year, and 2-year timepoints after surgery
  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.
  measure: Patient quality of life as measured by the GERD-HRQL scale
  time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
  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.
  measure: Patient satisfaction as measured by patient reported assessment
  time frame: Preop, 30-day, 1-year, and 2-year timepoints after surgery
  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.
  measure: 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
  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.
  measure: Immediate recurrence
  time frame: Within 45 days from surgery
  description: The rates of immediate paraesophageal recurrence (as defined as within 45 days of surgery) will be compared between the 2 groups.
  measure: Reoperations
  time frame: Throughout study up to 2 years after surgery
  description: Reoperation rates for paraesophageal hernia will be compared between the two groups throughout the study
  measure: Intraoperative complications
  time frame: At time of surgery
  description: Intraoperative complications (solid organ injury, etc.) will be recorded and compared between the two groups.
  measure: Clavien-Dindo Complications
  time frame: Throughout study up to 2 years after surgery
  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.
  measure: Comprehensive Complications Index (CCI)
  time frame: Throughout study up to 2 years after surgery
  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).
  measure: Foregut complications requiring reintervention
  time frame: Throughout study up to 2 years after surgery
  description: Foregut complications requiring reinterventions will be recorded for each patient and compared between the two groups.
  arm group label: Mesh-based crural reinforcement
  arm group type: Other
  description: Patient will receive Ovitex mesh to reinforce the crural repair
  arm group label: Pledgeted suture-based crural reinforcement
  arm group type: Other
  description: Patient will receive pledgeted sutures to reinforce the crural repair
  intervention type: Device
  intervention name: OviTex Mesh
  description: Patient will receive Ovitex Mesh (TELA Bio)
  arm group label: Mesh-based crural reinforcement
  intervention type: Other
  intervention name: Pledgeted sutures
  description: Patient will receive pledgeted sutures
  arm group label: Pledgeted suture-based crural reinforcement
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael J Rosen, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Michael J Rosen, MD
  phone: 216 445-3441
  email: rosenm@ccf.org
  last name: Ryan C Ellis, MD
  phone: 440 409-3948
  email: ellisr2@ccf.org
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Michael Rosen
  investigator title: Professor of Surgery, CCF Lerner College of Medicine
  mesh term: Hernia
  mesh term: Hernia, Hiatal
  sharing ipd: No