<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/NCT02987673</url>
  </required_header>
  <id_info>
    <org_study_id>MGB1</org_study_id>
    <nct_id>NCT02987673</nct_id>
  </id_info>
  <brief_title>MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function</brief_title>
  <official_title>Effects of Mini/One Anastomosis Gastric Bypass (MGB/OAGB) and Sleeve Gastrectomy (LSG) on Lower Esophageal Sphincter (LES) Function. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mario Musella MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background While several articles have reported about the effects of laparoscopic sleeve&#xD;
      gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has&#xD;
      discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is&#xD;
      expected to be the first randomized trial exploring and comparing these two interventions.&#xD;
&#xD;
      Setting &quot;Federico II&quot; University Hospital, Naples - ITALY.&#xD;
&#xD;
      Methods Fifty morbid obese patients are going to be studied. All patients presenting with a&#xD;
      normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or&#xD;
      MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and&#xD;
      esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and&#xD;
      24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or&#xD;
      MGB/OAGB.&#xD;
&#xD;
      Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2&#xD;
      patients determining a possible increase in gastroesophageal acid or non acid reflux?&#xD;
      Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual&#xD;
      LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or&#xD;
      both the procedures, is this to be primarily related to surgery per se or to weight loss?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modifications in terms of LES function</measure>
    <time_frame>12 months</time_frame>
    <description>Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? This will be measured by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Definition of the best procedure</measure>
    <time_frame>12 months</time_frame>
    <description>Does one between the two procedures outperform the other one in terms of eventual LES area modifications? This will be measured in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Causes of eventual modifications of LES function in relationship with a specific surgical procedure</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss? This will be evaluated in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Causes of eventual modifications of LES function in relationship with weight loss</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss? This will be evaluated in both procedures by the weight loss expressed as body mass index (BMI) points loss.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Morbid Obesity</condition>
  <condition>Gastroesophageal Reflux</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>Mini/One anastomosis gastric bypass</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic sleeve gastrectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Execution of a laparoscopic sleeve gastrectomy (LSG)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MGB/OAGB</intervention_name>
    <arm_group_label>Mini/One anastomosis gastric bypass</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LSG</intervention_name>
    <arm_group_label>Laparoscopic sleeve gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  80 morbid obese patients are going to be studied. All patients presenting with a&#xD;
             normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 40&#xD;
             pts) or MGB (arm 2 - 40 pts).-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients lost at follow up. Cancer patients at any stage.&#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>Mario Musella, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federico II University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annunziata Marfella</last_name>
    <phone>081746</phone>
    <phone_ext>2896</phone_ext>
    <email>segreteriamaster2015@libero.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Advanced Biomedical Sciences Department - &quot;Federico II&quot; University</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annunziata Marfella</last_name>
      <phone>+39081746</phone>
      <phone_ext>2896</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Del Genio G, Tolone S, Limongelli P, Brusciano L, D'Alessandro A, Docimo G, Rossetti G, Silecchia G, Iannelli A, del Genio A, del Genio F, Docimo L. Sleeve gastrectomy and development of &quot;de novo&quot; gastroesophageal reflux. Obes Surg. 2014 Jan;24(1):71-7. doi: 10.1007/s11695-013-1046-4.</citation>
    <PMID>24249251</PMID>
  </results_reference>
  <results_reference>
    <citation>Melissas J, Braghetto I, Molina JC, Silecchia G, Iossa A, Iannelli A, Foletto M. Gastroesophageal Reflux Disease and Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2430-5. doi: 10.1007/s11695-015-1906-1.</citation>
    <PMID>26428250</PMID>
  </results_reference>
  <results_reference>
    <citation>Casella G, Soricelli E, Giannotti D, Collalti M, Maselli R, Genco A, Redler A, Basso N. Long-term results after laparoscopic sleeve gastrectomy in a large monocentric series. Surg Obes Relat Dis. 2016 May;12(4):757-762. doi: 10.1016/j.soard.2015.09.028. Epub 2015 Oct 1.</citation>
    <PMID>26806727</PMID>
  </results_reference>
  <results_reference>
    <citation>Tolone S, Cristiano S, Savarino E, Lucido FS, Fico DI, Docimo L. Effects of omega-loop bypass on esophagogastric junction function. Surg Obes Relat Dis. 2016 Jan;12(1):62-9. doi: 10.1016/j.soard.2015.03.011. Epub 2015 Mar 27.</citation>
    <PMID>25979206</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Mario Musella MD</investigator_full_name>
    <investigator_title>Associate Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Mini/One anastomosis gastric bypass</keyword>
  <keyword>Sleeve Gastrectomy</keyword>
  <keyword>Gastro-esophageal sphincter function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Obesity, Morbid</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/NCT02987673
org study id: MGB1
nct id: NCT02987673
lead sponsor: 
has dmc: No
Background While several articles have reported about the effects of laparoscopic sleeve
      gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has
      discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is
      expected to be the first randomized trial exploring and comparing these two interventions.

      Setting "Federico II" University Hospital, Naples - ITALY.

      Methods Fifty morbid obese patients are going to be studied. All patients presenting with a
      normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or
      MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and
      esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and
      24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or
      MGB/OAGB.

      Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2
      patients determining a possible increase in gastroesophageal acid or non acid reflux?
      Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual
      LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or
      both the procedures, is this to be primarily related to surgery per se or to weight loss?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Modifications in terms of LES function
time frame: 12 months
description: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? This will be measured by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)
measure: Definition of the best procedure
time frame: 12 months
description: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? This will be measured in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)
measure: Causes of eventual modifications of LES function in relationship with a specific surgical procedure
time frame: 6 months and 12 months
description: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss? This will be evaluated in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)
measure: Causes of eventual modifications of LES function in relationship with weight loss
time frame: 6 months and 12 months
description: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss? This will be evaluated in both procedures by the weight loss expressed as body mass index (BMI) points loss.
arm group label: Mini/One anastomosis gastric bypass
arm group type: Experimental
description: Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB)
arm group label: Laparoscopic sleeve gastrectomy
arm group type: Active Comparator
description: Execution of a laparoscopic sleeve gastrectomy (LSG)
intervention type: Procedure
intervention name: MGB/OAGB
arm group label: Mini/One anastomosis gastric bypass
intervention type: Procedure
intervention name: LSG
arm group label: Laparoscopic sleeve gastrectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mario Musella, MD
role: Principal Investigator
affiliation: Federico II University
last name: Annunziata Marfella
phone: 081746
phone ext: 2896
email: segreteriamaster2015@libero.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Del Genio G, Tolone S, Limongelli P, Brusciano L, D'Alessandro A, Docimo G, Rossetti G, Silecchia G, Iannelli A, del Genio A, del Genio F, Docimo L. Sleeve gastrectomy and development of "de novo" gastroesophageal reflux. Obes Surg. 2014 Jan;24(1):71-7. doi: 10.1007/s11695-013-1046-4.
PMID: 24249251
citation: Melissas J, Braghetto I, Molina JC, Silecchia G, Iossa A, Iannelli A, Foletto M. Gastroesophageal Reflux Disease and Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2430-5. doi: 10.1007/s11695-015-1906-1.
PMID: 26428250
citation: Casella G, Soricelli E, Giannotti D, Collalti M, Maselli R, Genco A, Redler A, Basso N. Long-term results after laparoscopic sleeve gastrectomy in a large monocentric series. Surg Obes Relat Dis. 2016 May;12(4):757-762. doi: 10.1016/j.soard.2015.09.028. Epub 2015 Oct 1.
PMID: 26806727
citation: Tolone S, Cristiano S, Savarino E, Lucido FS, Fico DI, Docimo L. Effects of omega-loop bypass on esophagogastric junction function. Surg Obes Relat Dis. 2016 Jan;12(1):62-9. doi: 10.1016/j.soard.2015.03.011. Epub 2015 Mar 27.
PMID: 25979206
responsible party type: Sponsor-Investigator
investigator affiliation: Federico II University
investigator full name: Mario Musella MD
investigator title: Associate Professor of Surgery
mesh term: Gastroesophageal Reflux
mesh term: Obesity, Morbid
sharing ipd: No