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NCT04377230 Clinical Trial

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

Osteopenia Clinical Trial

Official title:
Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04377230
Other study ID # Garcilaso-Mex 20-3
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 7, 2020
Est. completion date May 1, 2022

Study information
Verified date May 2020
Source Hospital General Universitario Elche
Contact Carolina LLavero Garrido
Phone 649593020
Email carolinallavero@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• biliopancreatic limb length of 60cm.
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
• biliopancreatic limb length of 100cm.
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Hospital General Universitario Elche Instituto de Seguridad Social del Estado de Mexico y Municipios

Outcome
Type Measure Description Time frame Safety issue
Primary Bone mineral density Bone mineral density will be evealuated by absorptiometry at the level of lumbar column 2 years after surgery
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