BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass | NCT04377230

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

NCT04377230

Sponsor

Hospital General Universitario Elche

Status

Unknown status

Last Update Posted

May 6, 2020Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Osteopenia

Interventions

biliopancreatic limb length of 60cm.
biliopancreatic limb length of 100cm.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2020Estimated

Primary Completion Date

May 1, 2022Estimated

Completion Date

May 1, 2022Estimated

First Submitted Date

May 2, 2020

First Submission Date that Met QC Criteria

May 2, 2020

First Posted Date

May 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2020

Last Update Posted Date

May 6, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario ElchePrincipal Investigator

Lead Sponsor

Hospital General Universitario ElcheOTHER

Collaborators

Name	Class
Instituto de Seguridad Social del Estado de Mexico y Municipios	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biliopancreatic limb 60cm	Experimental	Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.	Procedure: biliopancreatic limb length of 60cm.
Biliopancreatic limb 100cm	Active Comparator	Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.	Procedure: biliopancreatic limb length of 100cm.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biliopancreatic limb length of 60cm.	Procedure	Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.	Biliopancreatic limb 60cm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bone mineral density	Bone mineral density will be evealuated by absorptiometry at the level of lumbar column	2 years after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carolina LLavero Garrido	Contact	649593020		carolinallavero@gmail.com
Gilberto Gonzalez	Contact	+5213322545864		gilpchmd@yahoo.com.mx

Overall Officials

Name	Affiliation	Role
Jaime Ruiz-Tovar	Garcilaso Clinic	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

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