NCT03607305

Brief Summary

Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm. Excess BMI loss 5 years after surgery was investigated

Trial Health

100
On Track

Trial Health Score

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

Enrollment
506

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

July 23, 2018

Last Update Submit

July 23, 2018

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Weight loss was evaluated

    5 years after surgery

Study Arms (2)

BP limb 70cm

ACTIVE COMPARATOR

Patients underwent a RYGB with a biliopancreatic limb of 70cm

Procedure: BP limb 70cm

BP limb 120cm

EXPERIMENTAL

Patients underwent a RYGB with a biliopancreatic limb of 120cm

Procedure: BP limb 120cm

Interventions

BP limb 70cmPROCEDURE

Performance of RYGB with a BP limb of 70cm

BP limb 70cm
BP limb 120cmPROCEDURE

Performance of RYGB with a BP limb of 120cm

BP limb 120cm

Eligibility Criteria

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

You may qualify if:

  • BMI \>40 Kg/m2
  • BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity
  • Age older than 18 years

You may not qualify if:

  • Patients undergoing other bariatric techniques than RYGB
  • Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
  • Any other surgical procedure added to the bariatric surgery
  • Impossibility to comply with pre-established clinical follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7.

    PMID: 31104282DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jaime Ruiz-Tovar

    HOSPITAL REY JUAN CARLOS

    PRINCIPAL INVESTIGATOR

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
Professor of Surgery

Study Record Dates

First Submitted

July 23, 2018

First Posted

July 31, 2018

Study Start

January 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 31, 2018

Record last verified: 2018-07