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
About this trial
This is an interventional treatment trial for Weight Loss
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.
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
NCT ID
NCT03467646
First Posted
March 10, 2018
Last Updated
March 10, 2018
Sponsor
Hospital General Universitario Elche
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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Long-term Follow up After SG vs RYGB vs OAGB
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