Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass

Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric

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

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Procedure: BP limb 70cm; Procedure: BP limb 120cm

Detailed Description

Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).

Excess BMI loss 5 years after surgery was investigated

• Study Type: Interventional
• Enrollment (Actual): 506
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BP limb 70cm; Patients underwent a RYGB with a biliopancreatic limb of 70cm	Procedure: BP limb 70cm; Performance of RYGB with a BP limb of 70cm
Experimental: BP limb 120cm; Patients underwent a RYGB with a biliopancreatic limb of 120cm	Procedure: BP limb 120cm; Performance of RYGB with a BP limb of 120cm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight loss was evaluated	5 years after surgery

Collaborators and Investigators

• Sponsor: Hospital General Universitario Elche
• Investigators: Principal Investigator: Jaime Ruiz-Tovar, Hospital Rey Juan Carlos

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: HGUE 2012-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No