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Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS) (OASIS)

Primary Purpose

Obesity, Morbid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
metabolic surgery (SADIS and OAGB)
Sponsored by
Consorci Sanitari Integral
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring OAGB, SADIS, bariatric surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients over 18 and under 65 who meet criteria for bariatric surgery. Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time Signature of the informed consent of the study Patients suitable for laparoscopic surgery Exclusion Criteria: Previous bariatric surgery 2-stage surgery Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery Other associated surgical procedures in the same intervention. Conversion to laparotomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A: SADI-S

    Group B: OAGB

    Arm Description

    SINGLE ANASTOMOSE DUODENAL SWITCH

    SINGLE ANASTOMOSE GASTRIC BY-PASS

    Outcomes

    Primary Outcome Measures

    the percentage of total weight loss (%TWL) of the patients after surgery

    Secondary Outcome Measures

    % of patients with gastroesophageal reflux (acid and bile) after surgery
    Number of deaths in the immediate postoperative period
    Number of Participants with complications in the immediate postoperative period
    Ratio of patients with more than 3 loose stools per day
    The ratio of patients with more than 3 loose stools per day will be evaluated as pathological. To assess the quality of the bowel movements, the Bristol Stool Form Scale questionnaire will be used. An evaluation of the number of bowel movements and their quality according to the Bristol Stool Form Scale questionnaire will be conducted at 1 year, 3 years, and 5 years after the surgery
    questionnaire of quality of life
    The quality of life will be assessed based on the results of the Moorehead-Ardelt II test and the Medical Outcomes Study Short Form-36 questionnaire. The Moorehead-Ardelt II questionnaire includes 6 parameters related to self-esteem, physical activity, social contact, job satisfaction, sexual pleasure, and eating habits. The minimum score is -3 and the maximum is +3. A score of 1.1 to 2 is considered a good result, and anything above 2.1 is considered very good. The SF-36 questionnaire includes 8 parameters such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The minimum score is 0 and the maximum is 100.
    Number of patients with nutritional deficiencies
    The main nutritional deficiencies to be evaluated after OAGB (One Anastomosis Gastric Bypass) and SADIS (Single Anastomosis Duodeno-Ileal Switch) are iron and/or vitamin B12 deficiency anemia, deficiencies in fat-soluble vitamins, calcium, and trace elements. The incidence of nutritional deficiencies will be assessed through routine blood tests at 1 year, 3 years, and 5 years after the surgery

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    July 10, 2023
    Sponsor
    Consorci Sanitari Integral
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05948852
    Brief Title
    Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)
    Acronym
    OASIS
    Official Title
    Randomized Prospective Study Comparing Two Hypoabsorption Techniques for the Treatment of Type III Obesity (Body Mass Index Between 45 - 49.9 Kg/m2): Single Anastomose Duodenal Switch (SADI-S) and Single Anastomose Gastric By-pass (OAGBP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Consorci Sanitari Integral

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to compare the percentage of total weight lost in long-term follow-up after two surgical interventions (SADIS and OAGB) in patients with morbid obesity BMI between 45-49.9.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Morbid
    Keywords
    OAGB, SADIS, bariatric surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: SADI-S
    Arm Type
    Experimental
    Arm Description
    SINGLE ANASTOMOSE DUODENAL SWITCH
    Arm Title
    Group B: OAGB
    Arm Type
    Active Comparator
    Arm Description
    SINGLE ANASTOMOSE GASTRIC BY-PASS
    Intervention Type
    Procedure
    Intervention Name(s)
    metabolic surgery (SADIS and OAGB)
    Intervention Description
    TWO HYPOABSORPTION TECHNIQUES FOR THE TREATMENT OF TYPE III OBESITY (BODY MASS INDEX BETWEEN 45 - 49.9 KG/M2): SINGLE ANASTOMOSE DUODENAL SWITCH (SADI-S) AND SINGLE ANASTOMOSE GASTRIC BY-PASS (OAGBP).
    Primary Outcome Measure Information:
    Title
    the percentage of total weight loss (%TWL) of the patients after surgery
    Time Frame
    Baseline, 1 year, 3 year, 5 year after SADI-S and OAGBP surgery
    Secondary Outcome Measure Information:
    Title
    % of patients with gastroesophageal reflux (acid and bile) after surgery
    Time Frame
    1 year, 3 year, 5 year after SADI-S and OAGBP surgery
    Title
    Number of deaths in the immediate postoperative period
    Time Frame
    up to day 90 post-intervention
    Title
    Number of Participants with complications in the immediate postoperative period
    Time Frame
    up to day 90 post-intervention
    Title
    Ratio of patients with more than 3 loose stools per day
    Description
    The ratio of patients with more than 3 loose stools per day will be evaluated as pathological. To assess the quality of the bowel movements, the Bristol Stool Form Scale questionnaire will be used. An evaluation of the number of bowel movements and their quality according to the Bristol Stool Form Scale questionnaire will be conducted at 1 year, 3 years, and 5 years after the surgery
    Time Frame
    1 year, 3 years, 5 years after the surgery
    Title
    questionnaire of quality of life
    Description
    The quality of life will be assessed based on the results of the Moorehead-Ardelt II test and the Medical Outcomes Study Short Form-36 questionnaire. The Moorehead-Ardelt II questionnaire includes 6 parameters related to self-esteem, physical activity, social contact, job satisfaction, sexual pleasure, and eating habits. The minimum score is -3 and the maximum is +3. A score of 1.1 to 2 is considered a good result, and anything above 2.1 is considered very good. The SF-36 questionnaire includes 8 parameters such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The minimum score is 0 and the maximum is 100.
    Time Frame
    1 year, 3 years, 5 years after SADI-S and OAGBP surgery
    Title
    Number of patients with nutritional deficiencies
    Description
    The main nutritional deficiencies to be evaluated after OAGB (One Anastomosis Gastric Bypass) and SADIS (Single Anastomosis Duodeno-Ileal Switch) are iron and/or vitamin B12 deficiency anemia, deficiencies in fat-soluble vitamins, calcium, and trace elements. The incidence of nutritional deficiencies will be assessed through routine blood tests at 1 year, 3 years, and 5 years after the surgery
    Time Frame
    1 year, 3 years, 5 years after SADI-S and OAGBP surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 and under 65 who meet criteria for bariatric surgery. Maximum BMI between 45 and 50 kg/m2 and indication for surgery in a time Signature of the informed consent of the study Patients suitable for laparoscopic surgery Exclusion Criteria: Previous bariatric surgery 2-stage surgery Contraindication for hypoabsorptive surgery due to previous pathology: inflammatory bowel disease, transplant recipient or transplant candidate, previous intestinal resection surgery Other associated surgical procedures in the same intervention. Conversion to laparotomy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sergio Sanchez Cordero, MD
    Phone
    +34 93 553 12 00
    Ext
    8902
    Email
    Sergi.SanchezCordero@sanitatintegral.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Two Hypoabsorption Techniques for the Treatment of Type III Obesity (OASIS)

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