<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/NCT04433507</url>
  </required_header>
  <id_info>
    <org_study_id>CER-2019-1642</org_study_id>
    <nct_id>NCT04433507</nct_id>
  </id_info>
  <brief_title>Antireflux Efficacy of Hiatal Hernia Repairs in Sleeve Gastrectomy Patients</brief_title>
  <official_title>Antireflux Efficacy of Hiatal Hernia Repairs Concomitant to Sleeve Gastrectomy in Obese Patients (BMI 35-50)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital du Sacre-Coeur de Montreal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital du Sacre-Coeur de Montreal</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastroesophageal reflux (GR) occurrence or persistence following a sleeve gastrectomy (SG)&#xD;
      can be correlated to several factors but it is clear that one of the key factors is a&#xD;
      persistent hiatal hernia or laxity of the esophageal hiatus. However, there are no clear&#xD;
      guidelines presently available on surgical management of small size hernias or an abnormal&#xD;
      hiatus. Therefore, hiatal hernia management is decided intraoperatively by the operating&#xD;
      surgeon. The main goal of this study is to evaluate the efficacy of primary hiatal hernia&#xD;
      repairs on gastroesophageal reflux concomitant to sleeve gastrectomy. The secondary&#xD;
      objectives are hiatal hernia recurrence following primary surgery and the occurrence of &quot;de&#xD;
      novo&quot; GR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background :&#xD;
&#xD;
      The Sleeve gastrectomy (SG) is the most common bariatric procedure worldwide because it is&#xD;
      the simplest to perform, from a technical standpoint, and the most efficient in terms of&#xD;
      metabolic control and weight loss. However, this intervention can lead to several&#xD;
      complications, including the onset or intensification of gastroesophageal reflux (GR) with&#xD;
      the associated impact on the patients' quality of life and a possible evolution into&#xD;
      Barrett's esophagus. One of the key factors in the development of this complication is a&#xD;
      persistent hiatal hernia.&#xD;
&#xD;
      Aims: The main objective of this study is to provide an objective evaluation of the effect of&#xD;
      primary hiatal hernia repair on GR concomitant to sleeve gastrectomy. The secondary&#xD;
      objectives are hiatal hernia recurrence following primary surgery and the occurrence of &quot;de&#xD;
      novo&quot; GR.&#xD;
&#xD;
      Methods :&#xD;
&#xD;
      A total of 100 patients will be recruited for the pilot study, with 50 patients in the SG&#xD;
      group and 50 in the SG + primary hiatal hernia repair group following randomization. Then,&#xD;
      based on a sample size study, recruitment will be continued as needed. None of the procedures&#xD;
      performed are experimental. All obese patients with a BMI between 35-50, aged 18-65 and&#xD;
      undergoing surgery for a SG in the institution's bariatric surgery department will be&#xD;
      eligible to participate in this study. Exclusion criteria will be hiatal hernias greater than&#xD;
      2 cm, a hiatal repair requiring a drain, prior bariatric surgery or any other&#xD;
      counterindication to SG. All patients will be evaluated preoperatively using: 1) EGD, 2)&#xD;
      esophageal manometric study, 3) pH assessment and 4) validated GR questionnaires (GERD-HRPL;&#xD;
      GCSI). Iconographic intraoperative data on hiatal morphology and the type of cure used will&#xD;
      be collected and records will be kept according to Ethics committee guidelines. After a&#xD;
      6-month follow-up the participants will undergo the same tests, including questionnaires, for&#xD;
      a medium-term profile.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment issues&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the presence of pathological Gastroesophageal reflux disease (GERD)</measure>
    <time_frame>Before surgery and 6 months after surgery</time_frame>
    <description>Pathological GERD will be assessed objectively using a 24 hour pH study and an EGD (esophagogastroduodenoscopy - presence of esophagitis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of hiatal hernia (intrathoracic migration of the sleeve)</measure>
    <time_frame>Before surgery and 6 months postoperative</time_frame>
    <description>Presence of hiatal hernia will be assessed using EGD and high-resolution esophageal manometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of hypotensive lower esophageal sphincter (LES)</measure>
    <time_frame>before the surgery and 6 months post-operative</time_frame>
    <description>Hypotensive LES will be measured objectively using a high-resolution esophageal manometry study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsening or new-onset gastroesophageal reflux disease</measure>
    <time_frame>before the surgery and 6 months post-operative</time_frame>
    <description>Worsening or new-onset gastroesophageal reflux disease will be measured using a validated reflux questionnaire (GERD-HRQL). The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to questions 1-15.&#xD;
Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Gastroesophageal Reflux</condition>
  <arm_group>
    <arm_group_label>Sleeve Gastrectomy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive a Sleeve Gastrectomy only, a mainly restrictive procedure which consists in creating a narrow tube-like stomach based on its lesser curvature.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleeve Gastrectomy + Hiatal Hernia repair group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive a Sleeve Gastrectomy combined with hiatal hernia repair. Hiatal Hernia repair consists of a peri-esophageal dissection proximal to the diaphragmatic crura to achieve an intra-abdominal esophageal length of 2-3 cm. The pillars will then be closed anteriorly and posteriorly using nonabsorbable sutures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sleeve gastrectomy</intervention_name>
    <description>Laparoscopic sleeve gastrectomy (LSG) is performed through a standard 5-port technique. After dissection of the greater curvature of the stomach, a narrow tube-like stomach is created after stapling off the lateral aspect of the stomach using a 40 French bougie as a guide.</description>
    <arm_group_label>Sleeve Gastrectomy + Hiatal Hernia repair group</arm_group_label>
    <arm_group_label>Sleeve Gastrectomy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hiatal Hernia repair</intervention_name>
    <description>Hiatal hernia repair consists in a circumferential dissection of the diaphragmatic crura to achieve an intra abdominal esophageal length of 2-3 cm. The crura will then be closed anteriorly and posteriorly using nonabsorbable sutures.</description>
    <arm_group_label>Sleeve Gastrectomy + Hiatal Hernia repair group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All obese patients with a BMI between 35-50&#xD;
&#xD;
          -  Aged 18-65 and undergoing surgery for a Sleeve Gastrectomy in institution's bariatric&#xD;
             surgery department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hiatal hernias greater than 2 cm,&#xD;
&#xD;
          -  hiatal repair requiring mesh placement&#xD;
&#xD;
          -  prior bariatric surgery or any other counterindication to Sleeve Gastrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Radu Pescarus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Sacré Coeur de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Sacré-Coeur de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 7, 2019</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hopital du Sacre-Coeur de Montreal</investigator_affiliation>
    <investigator_full_name>Radu Pescarus</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sleeve Gastrectomy</keyword>
  <keyword>Gastroesophageal reflux</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</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>


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/NCT04433507
org study id: CER-2019-1642
nct id: NCT04433507
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gastroesophageal reflux (GR) occurrence or persistence following a sleeve gastrectomy (SG)
      can be correlated to several factors but it is clear that one of the key factors is a
      persistent hiatal hernia or laxity of the esophageal hiatus. However, there are no clear
      guidelines presently available on surgical management of small size hernias or an abnormal
      hiatus. Therefore, hiatal hernia management is decided intraoperatively by the operating
      surgeon. The main goal of this study is to evaluate the efficacy of primary hiatal hernia
      repairs on gastroesophageal reflux concomitant to sleeve gastrectomy. The secondary
      objectives are hiatal hernia recurrence following primary surgery and the occurrence of "de
      novo" GR.
Background :

      The Sleeve gastrectomy (SG) is the most common bariatric procedure worldwide because it is
      the simplest to perform, from a technical standpoint, and the most efficient in terms of
      metabolic control and weight loss. However, this intervention can lead to several
      complications, including the onset or intensification of gastroesophageal reflux (GR) with
      the associated impact on the patients' quality of life and a possible evolution into
      Barrett's esophagus. One of the key factors in the development of this complication is a
      persistent hiatal hernia.

      Aims: The main objective of this study is to provide an objective evaluation of the effect of
      primary hiatal hernia repair on GR concomitant to sleeve gastrectomy. The secondary
      objectives are hiatal hernia recurrence following primary surgery and the occurrence of "de
      novo" GR.

      Methods :

      A total of 100 patients will be recruited for the pilot study, with 50 patients in the SG
      group and 50 in the SG + primary hiatal hernia repair group following randomization. Then,
      based on a sample size study, recruitment will be continued as needed. None of the procedures
      performed are experimental. All obese patients with a BMI between 35-50, aged 18-65 and
      undergoing surgery for a SG in the institution's bariatric surgery department will be
      eligible to participate in this study. Exclusion criteria will be hiatal hernias greater than
      2 cm, a hiatal repair requiring a drain, prior bariatric surgery or any other
      counterindication to SG. All patients will be evaluated preoperatively using: 1) EGD, 2)
      esophageal manometric study, 3) pH assessment and 4) validated GR questionnaires (GERD-HRPL;
      GCSI). Iconographic intraoperative data on hiatal morphology and the type of cure used will
      be collected and records will be kept according to Ethics committee guidelines. After a
      6-month follow-up the participants will undergo the same tests, including questionnaires, for
      a medium-term profile.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 50 patients in the SG group and 50 in the SG + primary hiatal hernia repair group following randomization
primary purpose: Prevention
masking: None (Open Label)
measure: Change in the presence of pathological Gastroesophageal reflux disease (GERD)
time frame: Before surgery and 6 months after surgery
description: Pathological GERD will be assessed objectively using a 24 hour pH study and an EGD (esophagogastroduodenoscopy - presence of esophagitis)
measure: Presence of hiatal hernia (intrathoracic migration of the sleeve)
time frame: Before surgery and 6 months postoperative
description: Presence of hiatal hernia will be assessed using EGD and high-resolution esophageal manometry
measure: Presence of hypotensive lower esophageal sphincter (LES)
time frame: before the surgery and 6 months post-operative
description: Hypotensive LES will be measured objectively using a high-resolution esophageal manometry study
measure: Worsening or new-onset gastroesophageal reflux disease
time frame: before the surgery and 6 months post-operative
description: Worsening or new-onset gastroesophageal reflux disease will be measured using a validated reflux questionnaire (GERD-HRQL). The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Total Score: Calculated by summing the individual scores to questions 1-15.
Greatest possible score (worst symptoms) = 75 Lowest possible score (no symptoms) = 0
arm group label: Sleeve Gastrectomy group
arm group type: Active Comparator
description: This group will receive a Sleeve Gastrectomy only, a mainly restrictive procedure which consists in creating a narrow tube-like stomach based on its lesser curvature.
arm group label: Sleeve Gastrectomy + Hiatal Hernia repair group
arm group type: Experimental
description: This group will receive a Sleeve Gastrectomy combined with hiatal hernia repair. Hiatal Hernia repair consists of a peri-esophageal dissection proximal to the diaphragmatic crura to achieve an intra-abdominal esophageal length of 2-3 cm. The pillars will then be closed anteriorly and posteriorly using nonabsorbable sutures.
intervention type: Procedure
intervention name: Sleeve gastrectomy
description: Laparoscopic sleeve gastrectomy (LSG) is performed through a standard 5-port technique. After dissection of the greater curvature of the stomach, a narrow tube-like stomach is created after stapling off the lateral aspect of the stomach using a 40 French bougie as a guide.
arm group label: Sleeve Gastrectomy + Hiatal Hernia repair group
arm group label: Sleeve Gastrectomy group
intervention type: Procedure
intervention name: Hiatal Hernia repair
description: Hiatal hernia repair consists in a circumferential dissection of the diaphragmatic crura to achieve an intra abdominal esophageal length of 2-3 cm. The crura will then be closed anteriorly and posteriorly using nonabsorbable sutures.
arm group label: Sleeve Gastrectomy + Hiatal Hernia repair group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Radu Pescarus, MD
role: Principal Investigator
affiliation: Hopital Sacré Coeur de Montréal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Hopital du Sacre-Coeur de Montreal
investigator full name: Radu Pescarus
investigator title: Principal Investigator
mesh term: Gastroesophageal Reflux
mesh term: Hernia, Hiatal
sharing ipd: No