<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/NCT04450082</url>
  </required_header>
  <id_info>
    <org_study_id>22062020</org_study_id>
    <secondary_id>22062020</secondary_id>
    <nct_id>NCT04450082</nct_id>
  </id_info>
  <brief_title>One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure</brief_title>
  <official_title>One Anastomosis Gastric Bypass After Sleeve Gastrectomy Failure: Does a Single Procedure Fit for All?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Sanitaria Locale Napoli 2 Nord</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Sanitaria Locale Napoli 2 Nord</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a retrospective analysis of prospectively collected data on 582 obese patients.&#xD;
      The primary aim of the study was to evaluate %Excess Weight Loss, Body Mass Index (BMI) and&#xD;
      remission of comorbidity at mid- and long-term follow-up after One Anastomosis Gastric Bypass&#xD;
      in subjects previously underwent Sleeve Gastrectomy. The secondary aim was to investigate the&#xD;
      onset of esophagitis and gastritis at Upper Endoscopy (UE) and the presence of nutritional&#xD;
      deficiencies in patients undergoing One Anastomosis Gastric Bypass as a redo surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a retrospective analysis of prospectively collected data on 582 obese patients.&#xD;
      It was conducted according to the ethical principles stated in the Declaration of Helsinki.&#xD;
      Written informed consent was obtained from all subjects. The study protocol was approved by&#xD;
      the Regional Ethics Committee. From January 2014 to February 2019, morbid obesity patients&#xD;
      who failed previous treatment with SG and referred to our bariatric center in the Department&#xD;
      of General and Emergency Surgery of &quot;A. Rizzoli&quot; Hospital in Lacco Ameno (Naples, Italy) for&#xD;
      a new bariatric procedure, were considered in the study. Redo surgery was only considered if&#xD;
      patients still met the criteria for primary bariatric surgery according to guidelines [body&#xD;
      mass index (BMI) &gt;35 kg/m2 with co-morbidities, BMI &gt;40 kg/m2] at the time clinical and&#xD;
      anthropometrical revision8. A postoperative follow-up of at least 24 months was also&#xD;
      considered inclusion criteria. Exclusion criteria were as follows: patients in whom Sleeve&#xD;
      Gastrectomy was already performed as revision surgery; patients underwent any other abdominal&#xD;
      surgical procedure after One Anastomosis Gastric Bypass not correlated to the bariatric&#xD;
      procedure, the presence at baseline of esophagitis B according to the Los Angeles scale,&#xD;
      Hiatal Hernia (HH) &gt; 5 cm and history of GERD-related symptoms (i.e., heartburn, pyrosis,&#xD;
      regurgitation) not responsive to proton pump inhibitors and/or severe Lower Esophageal&#xD;
      Sfinter incontinence. All procedures were performed by the same experienced bariatric&#xD;
      surgeons.&#xD;
&#xD;
      Pre-operative evaluation All patients underwent a multidisciplinary preoperative evaluation&#xD;
      including anthropometric measurements (height in cm, weight in kg, Body Mass Index in kg/m2),&#xD;
      comorbidity evaluation, preoperative Upper Endoscopy with Helicobacter Pylori test, abdomen&#xD;
      ultrasound, chest x-ray and nutritional status evaluation.&#xD;
&#xD;
      Radiographic barium swallow test was performed for the diagnosis of HH or presence of gastric&#xD;
      fundus. Barium swallow X-ray protocol consisted of five swallows of barium always using the&#xD;
      same amount of liquid; anteroposterior and oblique views were obtained in upright and supine&#xD;
      positions. Measurements were done using a standardized protocol: a distance of more than 2 cm&#xD;
      between the gastroesophageal junction and the diaphragmatic hiatus was defined as a sliding&#xD;
      Hiatal Hernia. Preoperative assessments of patient eligibility for bariatric surgery included&#xD;
      consultation with the multidisciplinary committee (surgeon, radiologist, diabetologist and&#xD;
      psychiatrist) to exclude patients with non-adjusted eating patterns or eating disorders.&#xD;
&#xD;
      Failure of Sleeve Gastrectomy was defined as a consequence of Insufficient Weight Loss or&#xD;
      Weight Regain. Insufficient Weight Loss or Weight Regain were analyzed considering the&#xD;
      modifications of the percentage of excess weight loss &lt;50% and/or the percentage of total&#xD;
      weight loss &lt;25%. A failure of Sleeve Gastrectomy was recognized if the subject was not able&#xD;
      to reduce the Body Mass Index &lt;35 with the persistence of co-morbidity or Body Mass Index &lt;40&#xD;
      at least 2-year after the primary surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">June 21, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index (kg/m2)</measure>
    <time_frame>24 months</time_frame>
    <description>Body Mass Index (kg/m2) at follow-up after OAGB in subjects previously underwent Sleeve Gastrectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastroesophageal reflux disease(GERD)</measure>
    <time_frame>at 24 months</time_frame>
    <description>Esophagitis grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks &lt; 5 mm in maximal length; Grade B: One or more mucosal breaks &gt; 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <arm_group>
    <arm_group_label>One anastomosis gastric bypass</arm_group_label>
    <description>One anastomosis gastric bypass in Sleeve Gastrectomy failure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>One anastomosis gastric bypass</intervention_name>
    <description>The linear stapler divides the stomach horizontally at the junction of the corpus and antrum at the level of crow's foot. In cases where the pre-operative study has shown the presence of the gastric fundus, if possible the fundus was dissected and a long, narrow gastric pouch was designed starting from beyond the crow's foot to just lateral the angle of His over a 42-Fr orogastric tube. Gastrojejunostomy was then performed between 200-220 cm distally to the ligament of Treitz using a 45-mm.</description>
    <arm_group_label>One anastomosis gastric bypass</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients underwent to One anastomosis gastric bypass after sleeve gastrectomy failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  informed consent.&#xD;
&#xD;
          -  morbid obesity defined as body mass index (BMI) 40 kg/m2&#xD;
&#xD;
          -  Sleeve Gastrectomy failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous bariatric surgical procedures other than Sleeve Gastrectomy&#xD;
&#xD;
          -  endocrine disorders causing obesity&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  psychiatric illness&#xD;
&#xD;
          -  inflammatory bowel disease&#xD;
&#xD;
          -  Barrett ́s oesophagus&#xD;
&#xD;
          -  severe gastro-oesophageal Reflux Disease with esophagitis B and C&#xD;
&#xD;
          -  a large hiatal hernia (&gt;5 cm)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Sanitaria Locale Napoli 2 Nord</investigator_affiliation>
    <investigator_full_name>Francesco Pizza</investigator_full_name>
    <investigator_title>Head of Bariatric Unit</investigator_title>
  </responsible_party>
  <keyword>Sleeve gastrectomy</keyword>
  <keyword>One Anastomosis gastric bypass</keyword>
  <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/NCT04450082
org study id: 22062020
secondary id: 22062020
nct id: NCT04450082
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a retrospective analysis of prospectively collected data on 582 obese patients.
      The primary aim of the study was to evaluate %Excess Weight Loss, Body Mass Index (BMI) and
      remission of comorbidity at mid- and long-term follow-up after One Anastomosis Gastric Bypass
      in subjects previously underwent Sleeve Gastrectomy. The secondary aim was to investigate the
      onset of esophagitis and gastritis at Upper Endoscopy (UE) and the presence of nutritional
      deficiencies in patients undergoing One Anastomosis Gastric Bypass as a redo surgery
This study is a retrospective analysis of prospectively collected data on 582 obese patients.
      It was conducted according to the ethical principles stated in the Declaration of Helsinki.
      Written informed consent was obtained from all subjects. The study protocol was approved by
      the Regional Ethics Committee. From January 2014 to February 2019, morbid obesity patients
      who failed previous treatment with SG and referred to our bariatric center in the Department
      of General and Emergency Surgery of "A. Rizzoli" Hospital in Lacco Ameno (Naples, Italy) for
      a new bariatric procedure, were considered in the study. Redo surgery was only considered if
      patients still met the criteria for primary bariatric surgery according to guidelines [body
      mass index (BMI) >35 kg/m2 with co-morbidities, BMI >40 kg/m2] at the time clinical and
      anthropometrical revision8. A postoperative follow-up of at least 24 months was also
      considered inclusion criteria. Exclusion criteria were as follows: patients in whom Sleeve
      Gastrectomy was already performed as revision surgery; patients underwent any other abdominal
      surgical procedure after One Anastomosis Gastric Bypass not correlated to the bariatric
      procedure, the presence at baseline of esophagitis B according to the Los Angeles scale,
      Hiatal Hernia (HH) > 5 cm and history of GERD-related symptoms (i.e., heartburn, pyrosis,
      regurgitation) not responsive to proton pump inhibitors and/or severe Lower Esophageal
      Sfinter incontinence. All procedures were performed by the same experienced bariatric
      surgeons.

      Pre-operative evaluation All patients underwent a multidisciplinary preoperative evaluation
      including anthropometric measurements (height in cm, weight in kg, Body Mass Index in kg/m2),
      comorbidity evaluation, preoperative Upper Endoscopy with Helicobacter Pylori test, abdomen
      ultrasound, chest x-ray and nutritional status evaluation.

      Radiographic barium swallow test was performed for the diagnosis of HH or presence of gastric
      fundus. Barium swallow X-ray protocol consisted of five swallows of barium always using the
      same amount of liquid; anteroposterior and oblique views were obtained in upright and supine
      positions. Measurements were done using a standardized protocol: a distance of more than 2 cm
      between the gastroesophageal junction and the diaphragmatic hiatus was defined as a sliding
      Hiatal Hernia. Preoperative assessments of patient eligibility for bariatric surgery included
      consultation with the multidisciplinary committee (surgeon, radiologist, diabetologist and
      psychiatrist) to exclude patients with non-adjusted eating patterns or eating disorders.

      Failure of Sleeve Gastrectomy was defined as a consequence of Insufficient Weight Loss or
      Weight Regain. Insufficient Weight Loss or Weight Regain were analyzed considering the
      modifications of the percentage of excess weight loss <50% and/or the percentage of total
      weight loss <25%. A failure of Sleeve Gastrectomy was recognized if the subject was not able
      to reduce the Body Mass Index <35 with the persistence of co-morbidity or Body Mass Index <40
      at least 2-year after the primary surgery.
observational model: Cohort
time perspective: Retrospective
measure: Body Mass Index (kg/m2)
time frame: 24 months
description: Body Mass Index (kg/m2) at follow-up after OAGB in subjects previously underwent Sleeve Gastrectomy
measure: Gastroesophageal reflux disease(GERD)
time frame: at 24 months
description: Esophagitis grading according to Los Angeles classification with Upper endoscopy (Grade A: One or more mucosal breaks < 5 mm in maximal length; Grade B: One or more mucosal breaks > 5mm, but without continuity across mucosal folds; Grade C: Mucosal breaks continuous between ≥ 2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D Mucosal breaks involving more than 75% of esophageal circumference
arm group label: One anastomosis gastric bypass
description: One anastomosis gastric bypass in Sleeve Gastrectomy failure
intervention type: Procedure
intervention name: One anastomosis gastric bypass
description: The linear stapler divides the stomach horizontally at the junction of the corpus and antrum at the level of crow's foot. In cases where the pre-operative study has shown the presence of the gastric fundus, if possible the fundus was dissected and a long, narrow gastric pouch was designed starting from beyond the crow's foot to just lateral the angle of His over a 42-Fr orogastric tube. Gastrojejunostomy was then performed between 200-220 cm distally to the ligament of Treitz using a 45-mm.
arm group label: One anastomosis gastric bypass
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Azienda Sanitaria Locale Napoli 2 Nord
investigator full name: Francesco Pizza
investigator title: Head of Bariatric Unit
sharing ipd: No