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

Hospital General Universitario Elche

Status and phase: Unknown; Phase 3

Conditions: Osteopenia

Treatments: Procedure: biliopancreatic limb length of 100cm.; Procedure: biliopancreatic limb length of 60cm.

Study type: Interventional

Funder types: Other

Identifiers

NCT04377230

Garcilaso-Mex 20-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Biliopancreatic limb 60cm

Experimental group

Description:

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.

Treatment:

Procedure: biliopancreatic limb length of 60cm.

Biliopancreatic limb 100cm

Active Comparator group

Description:

Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

Treatment:

Procedure: biliopancreatic limb length of 100cm.