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A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

NCT ID: NCT04609449

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-12-31

Brief Summary

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Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.

Detailed Description

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Conditions

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Bariatric Surgery Metabolic Surgery Roux-en-Y Gastric Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Long biliopancreatic limb

Patients submitted to long biliopancreatic limb Roux-en-Y gastric bypass.

Group Type EXPERIMENTAL

Long biliopancreatic limb Roux-en-Y gastric bypass.

Intervention Type PROCEDURE

Long biliopancreatic limb Roux-en-Y gastric bypass.

Standard biliopancreatic limb

Patients submitted to standard Roux-en-Y gastric bypass.

Group Type ACTIVE_COMPARATOR

Standard Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Standard Roux-en-Y gastric bypass

Interventions

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Long biliopancreatic limb Roux-en-Y gastric bypass.

Long biliopancreatic limb Roux-en-Y gastric bypass.

Intervention Type PROCEDURE

Standard Roux-en-Y gastric bypass

Standard Roux-en-Y gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient submitted to bariatric surgery
* All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity

Exclusion Criteria

•Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CARLOS ZERRWECK LOPEZ

OTHER_GOV

Sponsor Role lead

Responsible Party

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CARLOS ZERRWECK LOPEZ

Professor and Head of Department.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carlos Zerrweck, MD

Role: STUDY_DIRECTOR

Head of Department. The Obesity Clinic at Hospital General Tlahuac

Antonio Herrera, MD

Role: PRINCIPAL_INVESTIGATOR

The Obesity Clinic at Hospital General Tlahuac

Locations

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Hospital General Tlahuac

Mexico City, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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CZL-030619

Identifier Type: -

Identifier Source: org_study_id