BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass

Phase 3

• Conditions: Osteopenia
• Interventions: Procedure: biliopancreatic limb length of 60cm.; Procedure: biliopancreatic limb length of 100cm.

• Registration Number: NCT04377230
• Lead Sponsor: Hospital General Universitario Elche

Brief Summary

Patients will be randomized into 2 groups:

* Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm

* Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm

Bone mineral density will be evaluated before surgery and 2 years after it.

Detailed Description

Patients will be randomized into 2 groups:

* Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm

* Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)

Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06
• Study Start: 2020-05-07
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Body mass index >40 Kg/m2
• Body mass index >35 Kg/m2 associated to obesity related comorbidities

Exclusion Criteria

• Bone pathologies
• Active neoplasms
• Disorders in calcium or vitamin D metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biliopancreatic limb 60cm	biliopancreatic limb length of 60cm.	Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Biliopancreatic limb 100cm	biliopancreatic limb length of 100cm.	Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

Primary Outcome Measures

Name	Time	Method
Bone mineral density	2 years after surgery	Bone mineral density will be evealuated by absorptiometry at the level of lumbar column