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Clinical Trials/NCT04377230
NCT04377230
Unknown
Phase 3

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

Hospital General Universitario Elche0 sites200 target enrollmentMay 7, 2020
ConditionsOsteopenia

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Osteopenia
Sponsor
Hospital General Universitario Elche
Enrollment
200
Primary Endpoint
Bone mineral density
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 7, 2020
End Date
May 1, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital General Universitario Elche
Responsible Party
Principal Investigator
Principal Investigator

Jaime Ruiz-Tovar, MD, PhD

Department of Surgery

Hospital General Universitario Elche

Eligibility Criteria

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

Outcomes

Primary Outcomes

Bone mineral density

Time Frame: 2 years after surgery

Bone mineral density will be evealuated by absorptiometry at the level of lumbar column

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