<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/NCT04423575</url>
  </required_header>
  <id_info>
    <org_study_id>19-011</org_study_id>
    <nct_id>NCT04423575</nct_id>
  </id_info>
  <brief_title>Outpatient Bariatric Surgery</brief_title>
  <acronym>Bariatric Ambu</acronym>
  <official_title>Clinical and Economic Evaluation of Outpatient Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IHU Strasbourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IHU Strasbourg</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 first presents the organizational path and the health interventions included in&#xD;
      the care episode for outpatient bariatric surgery, as compared to the health interventions&#xD;
      usually performed in the care episode for bariatric surgery (including a conventional&#xD;
      hospitalization with at least one-night inpatient). Then, the study aims to estimate and to&#xD;
      compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care&#xD;
      episode, and also to evaluate the postoperative medical consequences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study first presents the organizational path and the health interventions included in&#xD;
      the care episode for outpatient bariatric surgery, as compared to the health interventions&#xD;
      usually performed in the care episode for bariatric surgery (including a conventional&#xD;
      hospitalization with at least one-night inpatient).&#xD;
&#xD;
      This single-center, matched case-control study will be conducted in the Endocrine and&#xD;
      Digestive Surgery Unit, Center of Excellence in Bariatric Surgery, of the University Hospital&#xD;
      of Strasbourg. All the patients scheduled for bariatric procedures (Roux-en-Y gastric bypass&#xD;
      and Sleeve Gastrectomy) and eligible for outpatient ambulatory procedures, will be checked&#xD;
      for the inclusion criteria and will be asked if they accepted the outpatient bariatric&#xD;
      procedure. If they accept, they will be included in the group A (&quot;Outpatients&quot;). At the end&#xD;
      of the inclusion period, the patients in group A will be paired to patients who were operated&#xD;
      in the same period, who had a conventional hospitalization and who will be matched based on&#xD;
      the type of intervention, the age and the ASA status. These patients will form the group B&#xD;
      (&quot;Inpatients&quot;).&#xD;
&#xD;
      The integrated care pathway of the outpatients was formalized in order to secure this care&#xD;
      pathway. It includes: patient education, enhanced rehabilitation program, first-position&#xD;
      surgical planning, follow-up by home nurse twice-a-day, standardized communication to&#xD;
      surgeons, and management of possible complications. All the health care interventions&#xD;
      (anticipated or not) will be recorded for both groups.&#xD;
&#xD;
      The study aims to estimate and to compare the costs of bariatric surgery inpatient care&#xD;
      episode to the costs of outpatient care episode, and also to evaluate the postoperative&#xD;
      medical consequences. A cost-minimization analysis will be performed from the perspective of&#xD;
      the healthcare provider. The direct costs of care production will be considered and estimated&#xD;
      by a micro-costing methodology. The time horizon is set from the pre-operative outpatient&#xD;
      appointment with the bariatric surgeon to the one-month post-operative appointment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">February 23, 2021</completion_date>
  <primary_completion_date type="Actual">February 23, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean cost evaluation of health care pathway</measure>
    <time_frame>from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment</time_frame>
    <description>Mean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean hospital length of stay</measure>
    <time_frame>from surgery to one month postoperatively</time_frame>
    <description>Mean hospital length of stay including readmission duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale</measure>
    <time_frame>at day 0, day 7 and day 30 postoperatively</time_frame>
    <description>The EQ-5D Quality of Life scale consists of :&#xD;
(i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.&#xD;
(ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state&quot; and &quot;Worst imaginable health state&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>from surgery to one month postoperatively</time_frame>
    <description>rate of postoperative complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory failure rate</measure>
    <time_frame>from surgery to one month postoperatively</time_frame>
    <description>rate of patients in Arm 1 who spent at least the first night in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>from surgery to one month postoperatively</time_frame>
    <description>rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs related to Complication</measure>
    <time_frame>from surgery to one month postoperatively</time_frame>
    <description>costs related to the postoperative complications will be assessed by micro-costing methodology</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>Outpatients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Health care pathway: patient education, communication to liberal nurses, first-position surgical planning, bariatric surgery (bypass or sleeve) as outpatient procedure, follow-up by home nurse twice-a-day, standardized communication to surgeons, management of possible complications</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inpatients</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Outpatient health care pathway</intervention_name>
    <description>A surgical procedure performed as an outpatient procedure means that the patient leaves the hospital before 8pm the same day. The surgery is identical but the standard care pathway is reinforced to insure a safe return to home.</description>
    <arm_group_label>Outpatients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient between the age of 18 and 60&#xD;
&#xD;
          -  Patient with a BMI of more than 35 with comorbidities or BMI of more than 40&#xD;
&#xD;
          -  Speaking and understanding French&#xD;
&#xD;
          -  Access to a phone&#xD;
&#xD;
          -  Access to a suitable healthcare facility near his residence&#xD;
&#xD;
          -  Appropriate post-operative residence&#xD;
&#xD;
          -  Moderate and/or controlled comorbidities&#xD;
&#xD;
          -  Patient able to understand research objectives and risks and to give informed consent&#xD;
&#xD;
          -  Patient not living alone&#xD;
&#xD;
          -  affiliated to the French health insurance system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient unable to provide informed consent&#xD;
&#xD;
          -  Previous bariatric surgery&#xD;
&#xD;
          -  Previous laparotomy&#xD;
&#xD;
          -  BMI of more than 50&#xD;
&#xD;
          -  Insulin-dependent diabetes&#xD;
&#xD;
          -  Uncorrected preoperative anaemia&#xD;
&#xD;
          -  Anticoagulation that cannot be interrupted&#xD;
&#xD;
          -  Ischemic heart disease&#xD;
&#xD;
          -  Untreated obstructive sleep apnea syndrome (OSA)&#xD;
&#xD;
          -  dialysis&#xD;
&#xD;
          -  Liver cirrhosis&#xD;
&#xD;
          -  Subject under guardianship, curatorship, safeguarding/protection of justice&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#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_official>
    <last_name>Mihaela IGNAT, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.santepubliquefrance.fr/determinants-de-sante/nutrition-et-activite-physique/documents/rapport-synthese/etude-de-sante-sur-l-environnement-la-biosurveillance-l-activite-physique-et-la-nutrition-esteban-2014-2016.-volet-nutrition.-chapitre-corpulence</url>
    <description>Epidemiologic study on obesity in France, 2017</description>
  </link>
  <link>
    <url>http://beh.santepubliquefrance.fr/beh/2018/5/pdf/2018_5_3.pdf</url>
    <description>Epidemiologic study on obesity surgery in France, 2018</description>
  </link>
  <link>
    <url>https://scansante.fr/applications/statistiques-activite-MCO-par-GHM</url>
    <description>PMSI (Programme de médicalisation des systèmes d'information)</description>
  </link>
  <reference>
    <citation>Cobourn C, Mumford D, Chapman MA, Wells L. Laparoscopic gastric banding is safe in outpatient surgical centers. Obes Surg. 2010 Apr;20(4):415-22. doi: 10.1007/s11695-009-0065-7.</citation>
    <PMID>20077029</PMID>
  </reference>
  <reference>
    <citation>McCarty TM, Arnold DT, Lamont JP, Fisher TL, Kuhn JA. Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass. Ann Surg. 2005 Oct;242(4):494-8; discussion 498-501. doi: 10.1097/01.sla.0000183354.66073.4c.</citation>
    <PMID>16192809</PMID>
  </reference>
  <reference>
    <citation>Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.</citation>
    <PMID>27901287</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe Obesity</keyword>
  <keyword>Outpatient Surgery</keyword>
  <keyword>Bariatric Surgery</keyword>
  <keyword>Roux-en-Y Gastric Bypass</keyword>
  <keyword>Sleeve Gastrectomy</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>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/NCT04423575
org study id: 19-011
nct id: NCT04423575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study first presents the organizational path and the health interventions included in
      the care episode for outpatient bariatric surgery, as compared to the health interventions
      usually performed in the care episode for bariatric surgery (including a conventional
      hospitalization with at least one-night inpatient). Then, the study aims to estimate and to
      compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care
      episode, and also to evaluate the postoperative medical consequences.
This study first presents the organizational path and the health interventions included in
      the care episode for outpatient bariatric surgery, as compared to the health interventions
      usually performed in the care episode for bariatric surgery (including a conventional
      hospitalization with at least one-night inpatient).

      This single-center, matched case-control study will be conducted in the Endocrine and
      Digestive Surgery Unit, Center of Excellence in Bariatric Surgery, of the University Hospital
      of Strasbourg. All the patients scheduled for bariatric procedures (Roux-en-Y gastric bypass
      and Sleeve Gastrectomy) and eligible for outpatient ambulatory procedures, will be checked
      for the inclusion criteria and will be asked if they accepted the outpatient bariatric
      procedure. If they accept, they will be included in the group A ("Outpatients"). At the end
      of the inclusion period, the patients in group A will be paired to patients who were operated
      in the same period, who had a conventional hospitalization and who will be matched based on
      the type of intervention, the age and the ASA status. These patients will form the group B
      ("Inpatients").

      The integrated care pathway of the outpatients was formalized in order to secure this care
      pathway. It includes: patient education, enhanced rehabilitation program, first-position
      surgical planning, follow-up by home nurse twice-a-day, standardized communication to
      surgeons, and management of possible complications. All the health care interventions
      (anticipated or not) will be recorded for both groups.

      The study aims to estimate and to compare the costs of bariatric surgery inpatient care
      episode to the costs of outpatient care episode, and also to evaluate the postoperative
      medical consequences. A cost-minimization analysis will be performed from the perspective of
      the healthcare provider. The direct costs of care production will be considered and estimated
      by a micro-costing methodology. The time horizon is set from the pre-operative outpatient
      appointment with the bariatric surgeon to the one-month post-operative appointment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Mean cost evaluation of health care pathway
time frame: from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment
description: Mean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology
measure: Mean hospital length of stay
time frame: from surgery to one month postoperatively
description: Mean hospital length of stay including readmission duration
measure: Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
time frame: at day 0, day 7 and day 30 postoperatively
description: The EQ-5D Quality of Life scale consists of :
(i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
(ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state" and "Worst imaginable health state".
measure: Complication rate
time frame: from surgery to one month postoperatively
description: rate of postoperative complications
measure: Ambulatory failure rate
time frame: from surgery to one month postoperatively
description: rate of patients in Arm 1 who spent at least the first night in the hospital
measure: Readmission rate
time frame: from surgery to one month postoperatively
description: rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0
measure: Costs related to Complication
time frame: from surgery to one month postoperatively
description: costs related to the postoperative complications will be assessed by micro-costing methodology
arm group label: Outpatients
arm group type: Experimental
description: Health care pathway: patient education, communication to liberal nurses, first-position surgical planning, bariatric surgery (bypass or sleeve) as outpatient procedure, follow-up by home nurse twice-a-day, standardized communication to surgeons, management of possible complications
arm group label: Inpatients
arm group type: No Intervention
description: Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital)
intervention type: Other
intervention name: Outpatient health care pathway
description: A surgical procedure performed as an outpatient procedure means that the patient leaves the hospital before 8pm the same day. The surgery is identical but the standard care pathway is reinforced to insure a safe return to home.
arm group label: Outpatients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Mihaela IGNAT, MD, PhD
role: Principal Investigator
affiliation: Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
facility: 
country: France
url: https://www.santepubliquefrance.fr/determinants-de-sante/nutrition-et-activite-physique/documents/rapport-synthese/etude-de-sante-sur-l-environnement-la-biosurveillance-l-activite-physique-et-la-nutrition-esteban-2014-2016.-volet-nutrition.-chapitre-corpulence
description: Epidemiologic study on obesity in France, 2017
url: http://beh.santepubliquefrance.fr/beh/2018/5/pdf/2018_5_3.pdf
description: Epidemiologic study on obesity surgery in France, 2018
url: https://scansante.fr/applications/statistiques-activite-MCO-par-GHM
description: PMSI (Programme de médicalisation des systèmes d'information)
citation: Cobourn C, Mumford D, Chapman MA, Wells L. Laparoscopic gastric banding is safe in outpatient surgical centers. Obes Surg. 2010 Apr;20(4):415-22. doi: 10.1007/s11695-009-0065-7.
PMID: 20077029
citation: McCarty TM, Arnold DT, Lamont JP, Fisher TL, Kuhn JA. Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass. Ann Surg. 2005 Oct;242(4):494-8; discussion 498-501. doi: 10.1097/01.sla.0000183354.66073.4c.
PMID: 16192809
citation: Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.
PMID: 27901287
responsible party type: Sponsor
mesh term: Obesity, Morbid
sharing ipd: No