<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/NCT04469712</url>
  </required_header>
  <id_info>
    <org_study_id>66095</org_study_id>
    <nct_id>NCT04469712</nct_id>
  </id_info>
  <brief_title>Non-randomized Prospective Comparison Between SASI Bipartition and RYGB</brief_title>
  <official_title>Long-term Outcomes of Bariatric Patients Treated With Gastric Bypass or Single-anastomosis Sleeve Ileal Bypass (SASI Bipartition)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aleris Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aleris Hospital</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>
      The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with&#xD;
      metabolic disorders in most of the reference centers. Recent data describes the SASI&#xD;
      Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the&#xD;
      advantage of being less technically difficult and less morbidity. In order to draw definite&#xD;
      conclusions regarding the procedure, larger series with longer follow-up are necessary.&#xD;
&#xD;
      Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI&#xD;
      Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits&#xD;
      at 3, 12, 24, 36, 48, and 60 months after surgery.&#xD;
&#xD;
      Results on weight loss, comorbidities resolution, complications, and need of supplements are&#xD;
      registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Weight change</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>Measured as percent of Excess Weight Loss (%EWL) using the following formula:&#xD;
((weight at each study visit - initial weight) / (initial weight - ideal weight)) X 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist size change</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>Waist size (in cm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical and surgical complication</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>According to Clavien-Dindo classification</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Operative time</measure>
    <time_frame>During surgery</time_frame>
    <description>Expressed in minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ferritin</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Iron</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parathyroid hormone (PTH)</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin B12</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting glycemia</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL</measure>
    <time_frame>before surgery up to 60 months after surgery</time_frame>
    <description>Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antidiabetic drugs</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antilipidemic drugs</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antihypertensive drugs</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)</measure>
    <time_frame>3 to 60 months after surgery</time_frame>
    <description>Evolution of the use of Continuous Positive Airway Pressure will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of OSA.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>SASI Bipartition</arm_group_label>
    <description>Subjects submitted to SASI Bipartition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Roux-en-Y gastric bypass</arm_group_label>
    <description>Subjects submitted to gastric bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SASI Bipartition</intervention_name>
    <description>SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.</description>
    <arm_group_label>SASI Bipartition</arm_group_label>
    <other_name>Single-anastomosis Sleeve Ileal Bypass</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gastric bypass</intervention_name>
    <description>A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.</description>
    <arm_group_label>Roux-en-Y gastric bypass</arm_group_label>
    <other_name>Roux-en-Y gastric bypass</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients approved for bariatric surgery at Bariatric Clinic, Aleris Hospital, Norway&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more&#xD;
        co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia,&#xD;
        arthritis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mental diseases&#xD;
&#xD;
          -  Drug addiction&#xD;
&#xD;
          -  Alcoholic&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebrahim Aghajani, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aleris Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aleris Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0264</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Aghajani E, Nergaard BJ, Leifson BG, Hedenbro J, Gislason H. The mesenteric defects in laparoscopic Roux-en-Y gastric bypass: 5 years follow-up of non-closure versus closure using the stapler technique. Surg Endosc. 2017 Sep;31(9):3743-3748. doi: 10.1007/s00464-017-5415-2. Epub 2017 Feb 15.</citation>
    <PMID>28205037</PMID>
  </reference>
  <reference>
    <citation>Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.</citation>
    <PMID>22609843</PMID>
  </reference>
  <reference>
    <citation>Mahdy T, Al Wahedi A, Schou C. Efficacy of single anastomosis sleeve ileal (SASI) bypass for type-2 diabetic morbid obese patients: Gastric bipartition, a novel metabolic surgery procedure: A retrospective cohort study. Int J Surg. 2016 Oct;34:28-34. doi: 10.1016/j.ijsu.2016.08.018. Epub 2016 Aug 19.</citation>
    <PMID>27545956</PMID>
  </reference>
  <reference>
    <citation>Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep. 2014;5(2):56-8. doi: 10.1016/j.ijscr.2013.12.002. Epub 2013 Dec 10.</citation>
    <PMID>24441436</PMID>
  </reference>
  <reference>
    <citation>Shah K, Johnny Nergard B, Stray Frazier K, Geir Leifsson B, Aghajani E, Gislason H. Long-term effects of laparoscopic Roux-en-Y gastric bypass on metabolic syndrome in patients with morbid obesity. Surg Obes Relat Dis. 2016 Sep-Oct;12(8):1449-1456. doi: 10.1016/j.soard.2016.03.017. Epub 2016 Mar 19.</citation>
    <PMID>27387692</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aleris Hospital</investigator_affiliation>
    <investigator_full_name>Ebrahim Aghajani</investigator_full_name>
    <investigator_title>Gastrointestinal Surgeon, PhD, Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Gastric Bypass,</keyword>
  <keyword>SASI Bipartition</keyword>
  <keyword>Weight loss</keyword>
  <keyword>GERD</keyword>
  <keyword>Internal Hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The results of the study will be published in a scientific journal.</ipd_description>
  </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/NCT04469712
org study id: 66095
nct id: NCT04469712
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.
The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with
      metabolic disorders in most of the reference centers. Recent data describes the SASI
      Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the
      advantage of being less technically difficult and less morbidity. In order to draw definite
      conclusions regarding the procedure, larger series with longer follow-up are necessary.

      Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI
      Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits
      at 3, 12, 24, 36, 48, and 60 months after surgery.

      Results on weight loss, comorbidities resolution, complications, and need of supplements are
      registered.
observational model: Case-Control
time perspective: Prospective
measure: Weight change
time frame: 3 to 60 months after surgery
description: Measured as percent of Excess Weight Loss (%EWL) using the following formula:
((weight at each study visit - initial weight) / (initial weight - ideal weight)) X 100
measure: Waist size change
time frame: 3 to 60 months after surgery
description: Waist size (in cm)
measure: Medical and surgical complication
time frame: 3 to 60 months after surgery
description: According to Clavien-Dindo classification
measure: Operative time
time frame: During surgery
description: Expressed in minutes
measure: Hemoglobin
time frame: before surgery up to 60 months after surgery
description: Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l
measure: Albumin
time frame: before surgery up to 60 months after surgery
description: Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l
measure: Ferritin
time frame: before surgery up to 60 months after surgery
description: Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l
measure: Iron
time frame: before surgery up to 60 months after surgery
description: Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l
measure: Parathyroid hormone (PTH)
time frame: before surgery up to 60 months after surgery
description: Measurement of PTH will explore the nutritional status of patients. Results will be expressed in pmol/L
measure: Vitamin B12
time frame: before surgery up to 60 months after surgery
description: Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l
measure: Vitamin D
time frame: before surgery up to 60 months after surgery
description: Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l
measure: Fasting glycemia
time frame: before surgery up to 60 months after surgery
description: Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
measure: HbA1c
time frame: before surgery up to 60 months after surgery
description: Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %
measure: Triglycerides
time frame: before surgery up to 60 months after surgery
description: Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l
measure: Cholesterol
time frame: before surgery up to 60 months after surgery
description: Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
measure: HDL
time frame: before surgery up to 60 months after surgery
description: Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
measure: LDL
time frame: before surgery up to 60 months after surgery
description: Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l
measure: Antidiabetic drugs
time frame: 3 to 60 months after surgery
description: Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
measure: Antilipidemic drugs
time frame: 3 to 60 months after surgery
description: Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
measure: Antihypertensive drugs
time frame: 3 to 60 months after surgery
description: Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.
measure: Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea (OSA)
time frame: 3 to 60 months after surgery
description: Evolution of the use of Continuous Positive Airway Pressure will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of OSA.
arm group label: SASI Bipartition
description: Subjects submitted to SASI Bipartition
arm group label: Roux-en-Y gastric bypass
description: Subjects submitted to gastric bypass
intervention type: Procedure
intervention name: SASI Bipartition
description: SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.
arm group label: SASI Bipartition
other name: Single-anastomosis Sleeve Ileal Bypass
intervention type: Procedure
intervention name: Gastric bypass
description: A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.
arm group label: Roux-en-Y gastric bypass
other name: Roux-en-Y gastric bypass
plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ebrahim Aghajani, PhD
role: Principal Investigator
affiliation: Aleris Hospital
facility: 
country: Norway
citation: Aghajani E, Nergaard BJ, Leifson BG, Hedenbro J, Gislason H. The mesenteric defects in laparoscopic Roux-en-Y gastric bypass: 5 years follow-up of non-closure versus closure using the stapler technique. Surg Endosc. 2017 Sep;31(9):3743-3748. doi: 10.1007/s00464-017-5415-2. Epub 2017 Feb 15.
PMID: 28205037
citation: Santoro S, Castro LC, Velhote MC, Malzoni CE, Klajner S, Castro LP, Lacombe A, Santo MA. Sleeve gastrectomy with transit bipartition: a potent intervention for metabolic syndrome and obesity. Ann Surg. 2012 Jul;256(1):104-10. doi: 10.1097/SLA.0b013e31825370c0.
PMID: 22609843
citation: Mahdy T, Al Wahedi A, Schou C. Efficacy of single anastomosis sleeve ileal (SASI) bypass for type-2 diabetic morbid obese patients: Gastric bipartition, a novel metabolic surgery procedure: A retrospective cohort study. Int J Surg. 2016 Oct;34:28-34. doi: 10.1016/j.ijsu.2016.08.018. Epub 2016 Aug 19.
PMID: 27545956
citation: Mui WL, Lee DW, Lam KK. Laparoscopic sleeve gastrectomy with loop bipartition: A novel metabolic operation in treating obese type II diabetes mellitus. Int J Surg Case Rep. 2014;5(2):56-8. doi: 10.1016/j.ijscr.2013.12.002. Epub 2013 Dec 10.
PMID: 24441436
citation: Shah K, Johnny Nergard B, Stray Frazier K, Geir Leifsson B, Aghajani E, Gislason H. Long-term effects of laparoscopic Roux-en-Y gastric bypass on metabolic syndrome in patients with morbid obesity. Surg Obes Relat Dis. 2016 Sep-Oct;12(8):1449-1456. doi: 10.1016/j.soard.2016.03.017. Epub 2016 Mar 19.
PMID: 27387692
responsible party type: Principal Investigator
investigator affiliation: Aleris Hospital
investigator full name: Ebrahim Aghajani
investigator title: Gastrointestinal Surgeon, PhD, Principal investigator
mesh term: Metabolic Syndrome
mesh term: Obesity, Morbid
mesh term: Postoperative Complications
sharing ipd: Undecided
ipd description: The results of the study will be published in a scientific journal.