NCT03838276

Brief Summary

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

  • Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
  • Group 2: AL 100cm and BPL 150cm Weight loss will be evaluated 1 year after surgery

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_3

Status
unknown

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

First Submitted

Initial submission to the registry

February 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

February 9, 2019

Last Update Submit

February 9, 2019

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Weight loss will be assessed 1 year after surgery

    1 year after surgery

Study Arms (2)

AL150 BPL100

ACTIVE COMPARATOR

Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb

Procedure: AL 150 BPL100

AL100 BPL150

EXPERIMENTAL

Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

Procedure: AL 100 BPL 150

Interventions

AL 150 BPL100PROCEDURE

Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb

AL150 BPL100
AL 100 BPL 150PROCEDURE

Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb

AL100 BPL150

Eligibility Criteria

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

You may qualify if:

  • BMI \> 40 Kg/m2
  • BMI \> 35 Kg/m2, associated with obesity-related comorbidities
  • Patients undergoing Roux-en-Y gastric bypass as bariatric procedure

You may not qualify if:

  • Patients undergoing Roux-en-Y gastric bypass as revisional procedure
  • Patients lost to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Santiago de Battista

    Hospital La PLata

    STUDY CHAIR

Central Study Contacts

Jaime Ruiz-Tovar

CONTACT

630534808jruiztovar@gmail.com

Lucas Rivalletto

CONTACT

+34654987159

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
Department of Surgery

Study Record Dates

First Submitted

February 9, 2019

First Posted

February 12, 2019

Study Start

February 15, 2019

Primary Completion

February 15, 2020

Study Completion

February 15, 2020

Last Updated

February 12, 2019

Record last verified: 2019-02