RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm | NCT03838276

Studies
RYGB AL 150cm BPL 100cm vs RYGB AL 100cc BPL 150cm

NCT03838276

Sponsor

Hospital General Universitario Elche

Status

Unknown status

Last Update Posted

Feb 12, 2019Actual

Enrollment

200Estimated

Phase

Phase 3

Conditions

Weight Loss

Interventions

AL 150 BPL100
AL 100 BPL 150

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

Feb 2019

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

Feb 15, 2019Estimated

Primary Completion Date

Feb 15, 2020Estimated

Completion Date

Feb 15, 2020Estimated

First Submitted Date

Feb 9, 2019

First Submission Date that Met QC Criteria

Feb 9, 2019

First Posted Date

Feb 12, 2019Actual

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

Feb 9, 2019

Last Update Posted Date

Feb 12, 2019Actual

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

Not provided

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

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

Group 1: Alimentary limb (AL) 150cm and biliopancreatic limb (BPL) 100cm
Group 2: AL 100cm and BPL 150cm

Weight loss will be evaluated 1 year after surgery

Detailed Description

A Roux-en-Y gastric bypass will be performed in all the cases. Patients will be randomized according the limb lengths:

Group 1: Alimentary limb 150cm and biliopancreatic limb 100cm
Group 2: Alimentary limb 100cm and biliopancreatic limb 150cm

Weight loss will be evaluated 1 year after surgery

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
AL150 BPL100	Active Comparator	Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb	Procedure: AL 150 BPL100
AL100 BPL150	Experimental	Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb	Procedure: AL 100 BPL 150

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AL 150 BPL100	Procedure	Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb	AL150 BPL100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss	Weight loss will be assessed 1 year after surgery	1 year after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI > 40 Kg/m2
BMI > 35 Kg/m2, associated with obesity-related comorbidities
Patients undergoing Roux-en-Y gastric bypass as bariatric procedure

Exclusion Criteria:

Patients undergoing Roux-en-Y gastric bypass as revisional procedure
Patients lost to follow-up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jaime Ruiz-Tovar	Contact	630534808		jruiztovar@gmail.com
Lucas Rivalletto	Contact	+34654987159

Overall Officials

Name	Affiliation	Role
Santiago de Battista	Hospital La PLata	Study Chair

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided