<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/NCT01685177</url>
  </required_header>
  <id_info>
    <org_study_id>SADI-CD</org_study_id>
    <nct_id>NCT01685177</nct_id>
  </id_info>
  <brief_title>Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient</brief_title>
  <acronym>SADI vs CD</acronym>
  <official_title>Prospective Randomized Trial Comparing Single-Anastomosis Duodeno-Ileal Bypass With Standard Roux-en-Y Duodenal Switch as a Second Step After a Sleeve Gastrectomy in the Super-Morbid Obese Patient</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Carlos, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Carlos, Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a&#xD;
      modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is&#xD;
      performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up.&#xD;
      Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least&#xD;
      equally to standard duodenal switch as a second step after sleeve gastrectomy in the&#xD;
      super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal&#xD;
      bypass is simpler to perform, quicker and has less postoperative short, mid and long-term&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate&#xD;
      in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. When the&#xD;
      sleeve is not enough for the patient, due to alimentary habits or to an excessive initial BMI&#xD;
      before surgery (usually over 50 - 55), a second-step operation should be performed to&#xD;
      increase effectiveness. Some patients are submitted to a second restrictive operation, i.e.:&#xD;
      a re-sleeve, a gastric plication or sleeve banding. Other group are offered a gastric bypass.&#xD;
      And, finally, a subset of patients, generally those with higher initial BMI, are offered a&#xD;
      malabsorptive operation. While re-sleeve is adequate for many patients, gastric bypass is not&#xD;
      offering a greater weight loss rate, and it is a complex operation requiring sectioning of&#xD;
      the sleeve and two anastomoses. We support the performance of malabsorptive operations which&#xD;
      warrant a better weight loss result for &quot;resistant&quot; patients needing a second-step. As&#xD;
      Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) has behaved as a&#xD;
      good primary operation for morbid obesity, we decided to test this one-loop reconstruction as&#xD;
      a second step operation. Results will be compared to those obtained with a Roux-en-Y duodenal&#xD;
      switch performed as a second step after a &quot;failed&quot; sleeve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2009</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>5 years from surgery</time_frame>
    <description>Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications and nutritional complications</measure>
    <time_frame>First 2 postoperative years</time_frame>
    <description>Operative and postoperative complications (i.e.: leaks, bleeding, hernia...) will be recorded. Nutritional evolution (malnutrition) will be analyzed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>SADI</arm_group_label>
    <description>Patients submitted to a second-step operation after a failed sleeve on which a single-anastomosis duodena-ileal bypass at 250 cm from the cecum is performed.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Fat, liver tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attended in the Surgery Clinic with Morbid Obesity submitted to a sleeve&#xD;
        gastrectomy and needing a second-step operation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Morbid obesity with initial BMI over 50 submitted to Sleeve Gastrectomy&#xD;
        more than 18 months earlier. Excess weight loss with the sleeve under 50%.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria: Mental retard, alcoholism, age over 60, concomitant neoplastic disease.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Andrés Sánchez-Pernaute, MD PhD</last_name>
    <phone>+3413303184</phone>
    <email>pernaute@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrés Sánchez-Pernaute, PhD MD</last_name>
      <phone>+3413303184</phone>
      <email>pernaute@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.</citation>
    <PMID>20798995</PMID>
  </reference>
  <reference>
    <citation>Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.</citation>
    <PMID>18040751</PMID>
  </reference>
  <results_reference>
    <citation>Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.</citation>
    <PMID>22963820</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Andres Sanchez-Pernaute</investigator_full_name>
    <investigator_title>Chief, Esophago-Gastric and Morbid Obesity Surgery Unit</investigator_title>
  </responsible_party>
  <keyword>Morbid obesity</keyword>
  <keyword>Sleeve gastrectomy</keyword>
  <keyword>Duodenal Switch</keyword>
  <keyword>SADI-S</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</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/NCT01685177
org study id: SADI-CD
nct id: NCT01685177
lead sponsor: 
has dmc: No
Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a
      modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is
      performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up.
      Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least
      equally to standard duodenal switch as a second step after sleeve gastrectomy in the
      super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal
      bypass is simpler to perform, quicker and has less postoperative short, mid and long-term
      complications.
Sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate
      in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. When the
      sleeve is not enough for the patient, due to alimentary habits or to an excessive initial BMI
      before surgery (usually over 50 - 55), a second-step operation should be performed to
      increase effectiveness. Some patients are submitted to a second restrictive operation, i.e.:
      a re-sleeve, a gastric plication or sleeve banding. Other group are offered a gastric bypass.
      And, finally, a subset of patients, generally those with higher initial BMI, are offered a
      malabsorptive operation. While re-sleeve is adequate for many patients, gastric bypass is not
      offering a greater weight loss rate, and it is a complex operation requiring sectioning of
      the sleeve and two anastomoses. We support the performance of malabsorptive operations which
      warrant a better weight loss result for "resistant" patients needing a second-step. As
      Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy (SADI-S) has behaved as a
      good primary operation for morbid obesity, we decided to test this one-loop reconstruction as
      a second step operation. Results will be compared to those obtained with a Roux-en-Y duodenal
      switch performed as a second step after a "failed" sleeve.
observational model: Cohort
time perspective: Prospective
measure: Weight loss
time frame: 5 years from surgery
description: Excess weight loss based on an ideal BMI = 25. EWL will be compared at 2 and 5 years from the second operation.
measure: Postoperative complications and nutritional complications
time frame: First 2 postoperative years
description: Operative and postoperative complications (i.e.: leaks, bleeding, hernia...) will be recorded. Nutritional evolution (malnutrition) will be analyzed.
arm group label: SADI
description: Patients submitted to a second-step operation after a failed sleeve on which a single-anastomosis duodena-ileal bypass at 250 cm from the cecum is performed.
Fat, liver tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Andrés Sánchez-Pernaute, MD PhD
phone: +3413303184
email: pernaute@yahoo.com
facility: 
status: Recruiting
contact: 
country: Spain
citation: Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.
PMID: 20798995
citation: Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.
PMID: 18040751
citation: Sanchez-Pernaute A, Rubio MA, Perez Aguirre E, Barabash A, Cabrerizo L, Torres A. Single-anastomosis duodenoileal bypass with sleeve gastrectomy: metabolic improvement and weight loss in first 100 patients. Surg Obes Relat Dis. 2013 Sep-Oct;9(5):731-5. doi: 10.1016/j.soard.2012.07.018. Epub 2012 Aug 7.
PMID: 22963820
responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Andres Sanchez-Pernaute
investigator title: Chief, Esophago-Gastric and Morbid Obesity Surgery Unit
mesh term: Obesity, Morbid