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
1 other identifier
interventional
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedStudy Start
First participant enrolled
May 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedMay 6, 2020
May 1, 2020
2 years
May 2, 2020
May 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Bone mineral density
Bone mineral density will be evealuated by absorptiometry at the level of lumbar column
2 years after surgery
Study Arms (2)
Biliopancreatic limb 60cm
EXPERIMENTALRoux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Biliopancreatic limb 100cm
ACTIVE COMPARATORRoux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
Interventions
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
Eligibility Criteria
You may qualify if:
- Body mass index \>40 Kg/m2
- Body mass index \>35 Kg/m2 associated to obesity related comorbidities
You may not qualify if:
- Bone pathologies
- Active neoplasms
- Disorders in calcium or vitamin D metabolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Ruiz-Tovar
Garcilaso Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The radiologist evaluating bone mineral density will be blinded to the biliopancreatic limb length
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery
Study Record Dates
First Submitted
May 2, 2020
First Posted
May 6, 2020
Study Start
May 7, 2020
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
May 6, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share