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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04377230
Enrollment
200
Registered
2020-05-06
Start date
2020-05-07
Completion date
2022-05-01
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopenia

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.

Interventions

PROCEDUREbiliopancreatic limb length of 60cm.

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

PROCEDUREbiliopancreatic limb length of 100cm.

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

Sponsors

Instituto de Seguridad Social del Estado de Mexico y Municipios
CollaboratorOTHER_GOV
Hospital General Universitario Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Masking description

The radiologist evaluating bone mineral density will be blinded to the biliopancreatic limb length

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bone mineral density2 years after surgeryBone mineral density will be evealuated by absorptiometry at the level of lumbar column

Contacts

Primary ContactCarolina LLavero Garrido
carolinallavero@gmail.com649593020
Backup ContactGilberto Gonzalez
gilpchmd@yahoo.com.mx+5213322545864

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026