NCT03467646

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
Last Updated

March 16, 2018

Status Verified

March 1, 2018

Enrollment Period

7.5 years

First QC Date

March 10, 2018

Last Update Submit

March 10, 2018

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

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

    1 , 2 and 5 years after surgery

Study Arms (3)

Sleeve Gastrectomy

ACTIVE COMPARATOR

Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure

Procedure: Sleeve Gastrectomy

Roux-en-Y gastric bypass

ACTIVE COMPARATOR

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

Procedure: Roux-en-Y gastric bypass

One-Anastomosis gastric bypass

EXPERIMENTAL

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

Procedure: One-Anastomosis Gastric Bypass

Interventions

Sleeve GastrectomyPROCEDURE

The patients undergo a Sleeve Gastrectomy as bariatric procedure

Sleeve Gastrectomy
Roux-en-Y gastric bypassPROCEDURE

The patients undergo a Roux-en-Y gastric bypass as bariatric procedure

Roux-en-Y gastric bypass
One-Anastomosis Gastric BypassPROCEDURE

The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure

One-Anastomosis gastric bypass

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29943058DERIVED

MeSH Terms

Conditions

Weight Loss

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Miguel Angel Carbajo

    Centro de Tratamiento de la Obesidad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Bariatric Surgery Unit. Hospital general Elche

Study Record Dates

First Submitted

March 10, 2018

First Posted

March 16, 2018

Study Start

June 1, 2010

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 16, 2018

Record last verified: 2018-03