xml: <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/NCT06021873</url>
    </required_header>
    <id_info>
      <org_study_id>5538</org_study_id>
      <nct_id>NCT06021873</nct_id>
    </id_info>
    <brief_title>Evaluation of the Non-inferiority of the Robotic Approach Over the Laparoscopic Approach in Patients Who Are Candidates for Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S)</brief_title>
    <acronym>LvRSADIS</acronym>
    <official_title>Evaluation of the Non-inferiority of the Robotic Approach Over the Laparoscopic Approach in Patients Who Are Candidates for Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
        Treating patients with super-obesity has always been challenging for bariatric surgeons due&#xD;
        to the higher risk of postoperative complications and the limited success of commonly used&#xD;
        bariatric procedures (restrictive and hypo-absorptive). In this context, these patients are&#xD;
        often considered for more complex procedures, such as hypo-absorptive interventions. Over the&#xD;
        past 15 years, a new hypo-absorptive procedure called single-anastomosis duodenal switch with&#xD;
        biliopancreatic diversion (SADI-S) has been introduced and recognized as a bariatric&#xD;
        procedure by leading national and international scientific societies. It has shown promising&#xD;
        short- and medium-term results regarding weight loss and metabolic improvements.&#xD;
  &#xD;
        The SADI-S procedure is a technically complex multi-quadrant surgery. This study aims to&#xD;
        evaluate the equivalence in terms of morbidity between laparoscopic and robotic approaches&#xD;
        for patients undergoing this procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with super-obesity (BMI≥50 kg/m2) present a significant challenge for bariatric&#xD;
        surgeons due to the complexity of their cases. Hypo-absorptive procedures are often necessary&#xD;
        to achieve the best results in weight loss and metabolic improvements. However, these&#xD;
        procedures are known to be among the most difficult to perform, especially in super-obese&#xD;
        patients. In recent years, there has been considerable interest in applying robotic&#xD;
        technology to bariatric surgery, specifically for hypo-absorptive procedures.&#xD;
  &#xD;
        The single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has gained&#xD;
        significant attention among the various hypo-absorptive procedures. This procedure is&#xD;
        technically less complex than others, thanks to its reconstruction with a single anastomosis&#xD;
        between the duodenum and the ileum. Despite its technical advantages, it maintains the&#xD;
        original procedure's desired bariatric and metabolic outcomes. SADI-S is now recognized as an&#xD;
        established bariatric procedure by major national and international scientific societies.&#xD;
  &#xD;
        However, there is ongoing debate regarding the equivalency of laparoscopic and robotic&#xD;
        approaches regarding complications, morbidity, and mortality. Thus, this study aims to&#xD;
        evaluate the safety and effectiveness of both minimally invasive approaches (laparoscopic and&#xD;
        robotic) in patients undergoing SADI-S.&#xD;
  &#xD;
        The study will have a monocentric design involving a prospective, interventional, and&#xD;
        randomized comparison between the two surgical strategies. The target population includes&#xD;
        patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria&#xD;
        being age 18 years or older and informed consent. Patients eligible for different bariatric&#xD;
        procedures be excluded.&#xD;
  &#xD;
        The study will span a duration of 5 years, and the aim is to enroll an average of 105&#xD;
        patients per year to achieve the final sample size. Primary endpoints include comparing the&#xD;
        risk of postoperative complications within 30 days of surgery between the laparoscopic and&#xD;
        robotic approaches. Secondary endpoints encompass evaluating intraoperative complications,&#xD;
        conversion rates, mortality, operative times, and post-operative hospital stay and conducting&#xD;
        a cost analysis of both approaches.&#xD;
  &#xD;
        However, there is ongoing debate regarding the equivalency of laparoscopic and robotic&#xD;
        approaches in terms of complications, morbidity, and mortality. Thus, the objective of this&#xD;
        study is to evaluate the safety and effectiveness of both minimally invasive approaches&#xD;
        (laparoscopic and robotic) in patients undergoing SADI-S.&#xD;
  &#xD;
        The study will have a monocentric design, involving a prospective, interventional, and&#xD;
        randomized comparison between the two surgical strategies. The target population includes&#xD;
        patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria&#xD;
        being age 18 years or older and informed consent. Patients eligible for different bariatric&#xD;
        procedures be excluded.&#xD;
  &#xD;
        The study will span a duration of 5 years, and the aim is to enroll an average of 105&#xD;
        patients per year to achieve the final sample size. Primary endpoints include comparing the&#xD;
        risk of post-operative complications within 30 days of surgery between the laparoscopic and&#xD;
        robotic approaches. Secondary endpoints encompass evaluating intraoperative complications,&#xD;
        conversion rates, mortality, operative times, post-operative hospital stay, and conducting a&#xD;
        cost analysis of both approaches.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2028</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>Single (Investigator)</masking>
      <masking_description>Monocentric, interventional, prospective, randomized 1:1, with comparison of two surgical approaches</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of post-operative complications</measure>
      <time_frame>30 days</time_frame>
      <description>Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy in order to evaluate the post-operative complications rate within 30 days from the surgical procedure. Complications will be expressed in absolute numbers and divided into major complications (grade III-IV) and minor complications (grade I-II) according to the Clavien-Dindo classification.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of morbidity, mortality and cost-analysis</measure>
      <time_frame>30 days</time_frame>
      <description>Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy. Our evaluation focuses on: the rate and percentage of intra-operative complications, the conversion rate and percentage, operative time (expressed as 'skin-to-skin' time in minutes), the length of hospital stay (in days), and cost analysis. In Italy, bariatric surgery has a flat reimbursement rate of 5681.3€ regardless of the surgical method (laparoscopic or robotic) or postoperative complications. We will conduct a cost analysis combining bottom-up micro-costing and top-down gross costing. Specifically, operating room costs, which encompass anesthesia, surgery, and scrub nurse professionals, as well as utilities, will be calculated with top-down gross costing. Hospital stay costs will combine micro-costing for drugs and tests with top-down costing for surgical/nurse professionals and accommodation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">105</enrollment>
    <condition>Obesity, Morbid</condition>
    <arm_group>
      <arm_group_label>Laparoscopic SADI-S</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with indication to laparoscopic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Robotic SADI-S</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients with indication to robotic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>SADI-S</intervention_name>
      <description>Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy</description>
      <arm_group_label>Laparoscopic SADI-S</arm_group_label>
      <arm_group_label>Robotic SADI-S</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Patients eligible for Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy&#xD;
               using a minimally invasive technique&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients eligible for different bariatric procedures than SADI-S&#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>Marco Raffaelli, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Francesco Pennestrì, Dr</last_name>
      <phone>+393280244528</phone>
      <email>francesco.pennestri@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
        <address>
          <city>Rome</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>minimally-invasive surgery</keyword>
    <keyword>robotic surgery</keyword>
    <keyword>single anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Morbid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021873
  org study id: 5538
  nct id: NCT06021873
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Treating patients with super-obesity has always been challenging for bariatric surgeons due
        to the higher risk of postoperative complications and the limited success of commonly used
        bariatric procedures (restrictive and hypo-absorptive). In this context, these patients are
        often considered for more complex procedures, such as hypo-absorptive interventions. Over the
        past 15 years, a new hypo-absorptive procedure called single-anastomosis duodenal switch with
        biliopancreatic diversion (SADI-S) has been introduced and recognized as a bariatric
        procedure by leading national and international scientific societies. It has shown promising
        short- and medium-term results regarding weight loss and metabolic improvements.
  
        The SADI-S procedure is a technically complex multi-quadrant surgery. This study aims to
        evaluate the equivalence in terms of morbidity between laparoscopic and robotic approaches
        for patients undergoing this procedure.
  Patients with super-obesity (BMI≥50 kg/m2) present a significant challenge for bariatric
        surgeons due to the complexity of their cases. Hypo-absorptive procedures are often necessary
        to achieve the best results in weight loss and metabolic improvements. However, these
        procedures are known to be among the most difficult to perform, especially in super-obese
        patients. In recent years, there has been considerable interest in applying robotic
        technology to bariatric surgery, specifically for hypo-absorptive procedures.
  
        The single-anastomosis duodenal switch with biliopancreatic diversion (SADI-S) has gained
        significant attention among the various hypo-absorptive procedures. This procedure is
        technically less complex than others, thanks to its reconstruction with a single anastomosis
        between the duodenum and the ileum. Despite its technical advantages, it maintains the
        original procedure's desired bariatric and metabolic outcomes. SADI-S is now recognized as an
        established bariatric procedure by major national and international scientific societies.
  
        However, there is ongoing debate regarding the equivalency of laparoscopic and robotic
        approaches regarding complications, morbidity, and mortality. Thus, this study aims to
        evaluate the safety and effectiveness of both minimally invasive approaches (laparoscopic and
        robotic) in patients undergoing SADI-S.
  
        The study will have a monocentric design involving a prospective, interventional, and
        randomized comparison between the two surgical strategies. The target population includes
        patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria
        being age 18 years or older and informed consent. Patients eligible for different bariatric
        procedures be excluded.
  
        The study will span a duration of 5 years, and the aim is to enroll an average of 105
        patients per year to achieve the final sample size. Primary endpoints include comparing the
        risk of postoperative complications within 30 days of surgery between the laparoscopic and
        robotic approaches. Secondary endpoints encompass evaluating intraoperative complications,
        conversion rates, mortality, operative times, and post-operative hospital stay and conducting
        a cost analysis of both approaches.
  
        However, there is ongoing debate regarding the equivalency of laparoscopic and robotic
        approaches in terms of complications, morbidity, and mortality. Thus, the objective of this
        study is to evaluate the safety and effectiveness of both minimally invasive approaches
        (laparoscopic and robotic) in patients undergoing SADI-S.
  
        The study will have a monocentric design, involving a prospective, interventional, and
        randomized comparison between the two surgical strategies. The target population includes
        patients eligible for SADI-S using a minimally invasive technique, with inclusion criteria
        being age 18 years or older and informed consent. Patients eligible for different bariatric
        procedures be excluded.
  
        The study will span a duration of 5 years, and the aim is to enroll an average of 105
        patients per year to achieve the final sample size. Primary endpoints include comparing the
        risk of post-operative complications within 30 days of surgery between the laparoscopic and
        robotic approaches. Secondary endpoints encompass evaluating intraoperative complications,
        conversion rates, mortality, operative times, post-operative hospital stay, and conducting a
        cost analysis of both approaches.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: Monocentric, interventional, prospective, randomized 1:1, with comparison of two surgical approaches
  measure: Evaluation of post-operative complications
  time frame: 30 days
  description: Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy in order to evaluate the post-operative complications rate within 30 days from the surgical procedure. Complications will be expressed in absolute numbers and divided into major complications (grade III-IV) and minor complications (grade I-II) according to the Clavien-Dindo classification.
  measure: Evaluation of morbidity, mortality and cost-analysis
  time frame: 30 days
  description: Comparison between the laparoscopic and robotic approach to Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy. Our evaluation focuses on: the rate and percentage of intra-operative complications, the conversion rate and percentage, operative time (expressed as 'skin-to-skin' time in minutes), the length of hospital stay (in days), and cost analysis. In Italy, bariatric surgery has a flat reimbursement rate of 5681.3€ regardless of the surgical method (laparoscopic or robotic) or postoperative complications. We will conduct a cost analysis combining bottom-up micro-costing and top-down gross costing. Specifically, operating room costs, which encompass anesthesia, surgery, and scrub nurse professionals, as well as utilities, will be calculated with top-down gross costing. Hospital stay costs will combine micro-costing for drugs and tests with top-down costing for surgical/nurse professionals and accommodation.
  arm group label: Laparoscopic SADI-S
  arm group type: Active Comparator
  description: Patients with indication to laparoscopic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy
  arm group label: Robotic SADI-S
  arm group type: Active Comparator
  description: Patients with indication to robotic Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy
  intervention type: Procedure
  intervention name: SADI-S
  description: Single-anastomosis duodeno-ileal bypass with sleeve gastrectomy
  arm group label: Laparoscopic SADI-S
  arm group label: Robotic SADI-S
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Marco Raffaelli, Prof
  role: Principal Investigator
  affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  last name: Francesco Pennestrì, Dr
  phone: +393280244528
  email: francesco.pennestri@policlinicogemelli.it
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Obesity, Morbid
  sharing ipd: Undecided