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Long-term Follow up After SG vs RYGB vs OAGB

Primary Purpose

Weight Loss

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Sleeve Gastrectomy
Roux-en-Y gastric bypass
One-Anastomosis Gastric Bypass
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

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

Inclusion Criteria:

  • body mass index (BMI) >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
  • age older than 18 years
  • Patients willing to participate in the study and giving their written consent

Exclusion Criteria:

  • patients undergoing other bariatric techniques than SG, RYGB and OAGB
  • Patients undergoing any other surgical procedure added to the bariatric surgery
  • patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
  • inability to understand the nature and purpose of the study and / or to accept written participation in the study
  • impossibility to comply with pre-established clinical follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Sleeve Gastrectomy

    Roux-en-Y gastric bypass

    One-Anastomosis gastric bypass

    Arm Description

    Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure

    Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure

    Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure

    Outcomes

    Primary Outcome Measures

    Weight loss
    The postoperative weight loss is investigated at 1, 2 and 5 years after surgery

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2018
    Last Updated
    March 10, 2018
    Sponsor
    Hospital General Universitario Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03467646
    Brief Title
    Long-term Follow up After SG vs RYGB vs OAGB
    Official Title
    Long-term Follow up After Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: A Comparative Study of Weight Loss
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital General Universitario Elche

    4. Oversight

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

    5. Study Description

    Brief Summary
    A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
    Detailed Description
    A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sleeve Gastrectomy
    Arm Type
    Active Comparator
    Arm Description
    Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure
    Arm Title
    Roux-en-Y gastric bypass
    Arm Type
    Active Comparator
    Arm Description
    Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure
    Arm Title
    One-Anastomosis gastric bypass
    Arm Type
    Experimental
    Arm Description
    Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Sleeve Gastrectomy
    Intervention Description
    The patients undergo a Sleeve Gastrectomy as bariatric procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    Roux-en-Y gastric bypass
    Intervention Description
    The patients undergo a Roux-en-Y gastric bypass as bariatric procedure
    Intervention Type
    Procedure
    Intervention Name(s)
    One-Anastomosis Gastric Bypass
    Intervention Description
    The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    The postoperative weight loss is investigated at 1, 2 and 5 years after surgery
    Time Frame
    1 , 2 and 5 years after 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: body mass index (BMI) >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity age older than 18 years Patients willing to participate in the study and giving their written consent Exclusion Criteria: patients undergoing other bariatric techniques than SG, RYGB and OAGB Patients undergoing any other surgical procedure added to the bariatric surgery patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study inability to understand the nature and purpose of the study and / or to accept written participation in the study impossibility to comply with pre-established clinical follow-up.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Miguel Angel Carbajo
    Organizational Affiliation
    Centro de Tratamiento de la Obesidad
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29943058
    Citation
    Ruiz-Tovar J, Carbajo MA, Jimenez JM, Castro MJ, Gonzalez G, Ortiz-de-Solorzano J, Zubiaga L. Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities. Surg Endosc. 2019 Feb;33(2):401-410. doi: 10.1007/s00464-018-6307-9. Epub 2018 Jun 25.
    Results Reference
    derived

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