<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/NCT04450628</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00081655</org_study_id>
    <secondary_id>01-20-07</secondary_id>
    <secondary_id>Pro00040539</secondary_id>
    <nct_id>NCT04450628</nct_id>
  </id_info>
  <brief_title>Esophagogastric Junction Distensibility During Hiatal Hernia Repair</brief_title>
  <official_title>Esophagogastric Junction Distensibility During Hiatal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on&#xD;
      the distensibility of the esophagogastric junction (EGJ) as measured by FLIP&#xD;
      topography/impedance planimetry. The investigators also aim to assess for any correlation&#xD;
      between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia&#xD;
      scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients referred for antireflux surgery and/or hiatal hernia repair will be considered for&#xD;
      enrollment. Standard preoperative evaluation will include esophagogastroduodenoscopy (EGD) to&#xD;
      assess for intraluminal pathology including esophagitis, columnar lined esophagus suggestive&#xD;
      of Barrett's esophagus, intraluminal masses, and to measure hernia size. Patients will also&#xD;
      undergo preoperative high resolution esophageal manometry testing with impedance as&#xD;
      clinically indicated to evaluate esophageal motility as assessed by standardized Chicago&#xD;
      Classification V3. Manometry will occasionally be avoided in patients with paraesophageal&#xD;
      hernias without substantial dysphagia or those not amenable to manometry, with appropriate&#xD;
      upper gastrointestinal radiology imaging (UGI), who will be having partial fundoplications.&#xD;
      UGI is also a routine preoperative evaluation. Furthermore, pH testing for evaluation of acid&#xD;
      reflux will be performed in patients without LA grade C or D esophagitis, paraesophageal&#xD;
      hernia, or pathologic confirmation of Barrett's esophagus.&#xD;
&#xD;
      Patients appropriate for enrollment will be consented in the office setting. Preoperative&#xD;
      baseline evaluations of symptom severity will be assessed via the GERD-HRQL survey and Mayo&#xD;
      Dysphagia Questionnaire. Surgery will be scheduled and patients will undergo intraoperative&#xD;
      impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area,&#xD;
      balloon pressure, minimum diameter, compliance, length of high pressure segment, and&#xD;
      distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be&#xD;
      performed to 30ml and 40ml for up to a minute for each volume of distension. An initial&#xD;
      baseline measurement will be obtained after establishment of pneumoperitoneum. A second&#xD;
      measurement will occur following hiatal dissection and mobilization but prior to crural&#xD;
      closure. Two additional measurements will be obtained after hiatal closure and after&#xD;
      fundoplication.&#xD;
&#xD;
      Surgeons will be blinded to EndoFLIP results for half of the cases, with the first 25 cases&#xD;
      blinded and the second 25 cases with the surgeons unblinded. There will be interim analysis&#xD;
      between the two groups' surgeries. During blinded cases no adjustment will be made to the&#xD;
      surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed&#xD;
      of the measured values. After the first 25 cases, the surgeons will be unblinded and be able&#xD;
      to determine goal impedance planimetry values based on patient postoperative symptom scores.&#xD;
      In the following 25 unblinded cases, the surgeon will be able to augment the surgical intent&#xD;
      based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the&#xD;
      fundoplication. Patients will be blinded to the type of procedure (i.e. surgeon blinded or&#xD;
      unblinded). The EndoFLIP catheters and generator will be provided by Medtronic, at no cost to&#xD;
      the patient. Medtronic will also cover the fees associated with the EndoFLIP procedure (CPT&#xD;
      91040 is used).&#xD;
&#xD;
      Postoperative clinical care will proceed as per standard protocol for foregut surgery, with 1&#xD;
      additional office visit. Reports of postoperative symptomatology and QOL will be performed,&#xD;
      via GERD-HRQL and Mayo Dysphagia Questionnaire during follow up clinic appointments at 2&#xD;
      weeks and 6 weeks postoperative, and with additional long-term follow-up of at 6 months.&#xD;
      Long-term follow-up will again assess for QOL symptoms via GERD-HRQL and the Mayo Dysphagia&#xD;
      Questionnaire. The 6 month follow-up visit is not typical practice and the patients cost for&#xD;
      this visit will be covered by Medtronic. Per standard clinical care, recurrence of symptoms&#xD;
      or dysphagia at any point may lead to additional postoperative testing, including UGI, EGD,&#xD;
      pH testing, esophageal manometry, CT scan, or EndoFLIP. Postoperative GERD-HRQL and Mayo&#xD;
      Dysphagia score results will be compared to intraoperative EndoFLIP measurements in interim&#xD;
      and final analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Surgeons will be blinded to EndoFLIP results for half of the cases, with the first 25 cases blinded and the second 25 cases with the surgeons unblinded. There will be interim analysis between the two groups' surgeries. During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. After the first 25 cases, the surgeons will be unblinded and be able to determine goal impedance planimetry values based on patient postoperative symptom scores.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Surgeons will be blinded to EndoFLIP results for half of the cases, with the first 25 cases blinded and the second 25 cases with the surgeons unblinded. There will be interim analysis between the two groups' surgeries. During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. After the first 25 cases, the surgeons will be unblinded and be able to determine goal impedance planimetry values based on patient postoperative symptom scores. In the following 25 unblinded cases, the surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication . Patients will be blinded to the type of procedure (i.e. surgeon blinded or unblinded).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in distensibility index</measure>
    <time_frame>6 months</time_frame>
    <description>Change in distensibility index of the esophagogastric junction (EGJ) as measured by EndoFLIP before, during, and after hiatal hernia repair (EndoFLIP distensibility index values range from 0 to 98 with higher numbers indicating a tighter EGJ).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-op GERD symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Postoperative symptoms as measured by Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire (GERD-HRQL). The lowest possible score for the GERD-HRQL is 0 and the highest possible score is 75 (higher scores are correlated with worse outcomes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-op dysphagia symptoms</measure>
    <time_frame>6 months</time_frame>
    <description>Postoperative symptoms as measured by the Mayo Dysphagia Questionnaire (MDQ-30). The lowest possible score for the MDQ-30 is 0 and the highest score is 100 (higher scores are correlated with worse outcomes).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Esophagogastric Junction Distensibility</condition>
  <condition>Hiatal Hernia</condition>
  <arm_group>
    <arm_group_label>Surgeon blinded</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values.&#xD;
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgeon unblinded</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.&#xD;
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgeon unblinded</intervention_name>
    <description>The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.&#xD;
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.</description>
    <arm_group_label>Surgeon unblinded</arm_group_label>
    <other_name>EndoFLIP 1.0 System EF-100</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EndoFLIP 1.0 System EF-100</intervention_name>
    <description>The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.&#xD;
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.</description>
    <arm_group_label>Surgeon unblinded</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient undergoing hiatal hernia repair (types I-IV included) and fundoplication&#xD;
&#xD;
          -  Absence of spastic esophageal disorders (i.e. jackhammer esophagus, achalasia types&#xD;
             I-III) or esophageal dysmotility (any evidence of ineffective esophageal motility&#xD;
             disorder with failed swallows in &gt; 50% of swallows and DCI &lt; 450, or fragmented&#xD;
             peristalsis as defined by Chicago Classification) assessed by preoperative&#xD;
             high-resolution manometry&#xD;
&#xD;
          -  Adult patients ≥18 years&#xD;
&#xD;
          -  Elective repairs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Redo hiatal hernia repairs&#xD;
&#xD;
          -  Emergent repairs&#xD;
&#xD;
          -  Patients with contraindication to surgery or endoscopy&#xD;
&#xD;
          -  Patients with esophageal varices&#xD;
&#xD;
          -  Cases with insufficient esophageal length in which fundoplication is unable to be&#xD;
             performed or a Collis gastroplasty is required&#xD;
&#xD;
          -  Presence of IEM on Manometry&#xD;
&#xD;
          -  Connective tissue diseases such as scleroderma or lupus&#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>Paul D Colavita, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Greg T Scarola, MS</last_name>
    <phone>704-355-5379</phone>
    <email>Gregory.Scarola@atriumhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Atrium Health - Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Greg T Scarola, MS</last_name>
      <phone>704-355-5379</phone>
      <email>Gregory.Scarola@atriumhealth.org</email>
    </contact>
    <investigator>
      <last_name>Paul D Colavita, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Todd Heniford, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Baharak Moshiree, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EndoFLIP</keyword>
  <keyword>Distensibility of the esophagogastric junction</keyword>
  <keyword>Gastroesophageal Reflux Disease-Health Related Quality of Life survey</keyword>
  <keyword>Mayo Dysphagia Questionnaire</keyword>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04450628
org study id: IRB00081655
secondary id: 01-20-07
secondary id: Pro00040539
nct id: NCT04450628
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on
      the distensibility of the esophagogastric junction (EGJ) as measured by FLIP
      topography/impedance planimetry. The investigators also aim to assess for any correlation
      between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia
      scores.
Patients referred for antireflux surgery and/or hiatal hernia repair will be considered for
      enrollment. Standard preoperative evaluation will include esophagogastroduodenoscopy (EGD) to
      assess for intraluminal pathology including esophagitis, columnar lined esophagus suggestive
      of Barrett's esophagus, intraluminal masses, and to measure hernia size. Patients will also
      undergo preoperative high resolution esophageal manometry testing with impedance as
      clinically indicated to evaluate esophageal motility as assessed by standardized Chicago
      Classification V3. Manometry will occasionally be avoided in patients with paraesophageal
      hernias without substantial dysphagia or those not amenable to manometry, with appropriate
      upper gastrointestinal radiology imaging (UGI), who will be having partial fundoplications.
      UGI is also a routine preoperative evaluation. Furthermore, pH testing for evaluation of acid
      reflux will be performed in patients without LA grade C or D esophagitis, paraesophageal
      hernia, or pathologic confirmation of Barrett's esophagus.

      Patients appropriate for enrollment will be consented in the office setting. Preoperative
      baseline evaluations of symptom severity will be assessed via the GERD-HRQL survey and Mayo
      Dysphagia Questionnaire. Surgery will be scheduled and patients will undergo intraoperative
      impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area,
      balloon pressure, minimum diameter, compliance, length of high pressure segment, and
      distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be
      performed to 30ml and 40ml for up to a minute for each volume of distension. An initial
      baseline measurement will be obtained after establishment of pneumoperitoneum. A second
      measurement will occur following hiatal dissection and mobilization but prior to crural
      closure. Two additional measurements will be obtained after hiatal closure and after
      fundoplication.

      Surgeons will be blinded to EndoFLIP results for half of the cases, with the first 25 cases
      blinded and the second 25 cases with the surgeons unblinded. There will be interim analysis
      between the two groups' surgeries. During blinded cases no adjustment will be made to the
      surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed
      of the measured values. After the first 25 cases, the surgeons will be unblinded and be able
      to determine goal impedance planimetry values based on patient postoperative symptom scores.
      In the following 25 unblinded cases, the surgeon will be able to augment the surgical intent
      based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the
      fundoplication. Patients will be blinded to the type of procedure (i.e. surgeon blinded or
      unblinded). The EndoFLIP catheters and generator will be provided by Medtronic, at no cost to
      the patient. Medtronic will also cover the fees associated with the EndoFLIP procedure (CPT
      91040 is used).

      Postoperative clinical care will proceed as per standard protocol for foregut surgery, with 1
      additional office visit. Reports of postoperative symptomatology and QOL will be performed,
      via GERD-HRQL and Mayo Dysphagia Questionnaire during follow up clinic appointments at 2
      weeks and 6 weeks postoperative, and with additional long-term follow-up of at 6 months.
      Long-term follow-up will again assess for QOL symptoms via GERD-HRQL and the Mayo Dysphagia
      Questionnaire. The 6 month follow-up visit is not typical practice and the patients cost for
      this visit will be covered by Medtronic. Per standard clinical care, recurrence of symptoms
      or dysphagia at any point may lead to additional postoperative testing, including UGI, EGD,
      pH testing, esophageal manometry, CT scan, or EndoFLIP. Postoperative GERD-HRQL and Mayo
      Dysphagia score results will be compared to intraoperative EndoFLIP measurements in interim
      and final analysis.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Surgeons will be blinded to EndoFLIP results for half of the cases, with the first 25 cases blinded and the second 25 cases with the surgeons unblinded. There will be interim analysis between the two groups' surgeries. During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. After the first 25 cases, the surgeons will be unblinded and be able to determine goal impedance planimetry values based on patient postoperative symptom scores.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Surgeons will be blinded to EndoFLIP results for half of the cases, with the first 25 cases blinded and the second 25 cases with the surgeons unblinded. There will be interim analysis between the two groups' surgeries. During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values. After the first 25 cases, the surgeons will be unblinded and be able to determine goal impedance planimetry values based on patient postoperative symptom scores. In the following 25 unblinded cases, the surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication . Patients will be blinded to the type of procedure (i.e. surgeon blinded or unblinded).
measure: Change in distensibility index
time frame: 6 months
description: Change in distensibility index of the esophagogastric junction (EGJ) as measured by EndoFLIP before, during, and after hiatal hernia repair (EndoFLIP distensibility index values range from 0 to 98 with higher numbers indicating a tighter EGJ).
measure: Post-op GERD symptoms
time frame: 6 months
description: Postoperative symptoms as measured by Gastroesophageal Reflux Disease Health Related Quality of Life Questionnaire (GERD-HRQL). The lowest possible score for the GERD-HRQL is 0 and the highest possible score is 75 (higher scores are correlated with worse outcomes).
measure: Post-op dysphagia symptoms
time frame: 6 months
description: Postoperative symptoms as measured by the Mayo Dysphagia Questionnaire (MDQ-30). The lowest possible score for the MDQ-30 is 0 and the highest score is 100 (higher scores are correlated with worse outcomes).
arm group label: Surgeon blinded
arm group type: No Intervention
description: During blinded cases no adjustment will be made to the surgical procedure based on EndoFLIP results, as the operating surgeon will not be informed of the measured values.
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
arm group label: Surgeon unblinded
arm group type: Experimental
description: The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
intervention type: Procedure
intervention name: Surgeon unblinded
description: The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
arm group label: Surgeon unblinded
other name: EndoFLIP 1.0 System EF-100
intervention type: Device
intervention name: EndoFLIP 1.0 System EF-100
description: The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.
Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication.
arm group label: Surgeon unblinded
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul D Colavita, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
last name: Greg T Scarola, MS
phone: 704-355-5379
email: Gregory.Scarola@atriumhealth.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Hiatal