A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass: Early Outcomes of a Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Roux-en-Y Gastric Bypass; Bariatric Surgery; Metabolic Surgery
• Intervention / Treatment: Procedure: Long biliopancreatic limb Roux-en-Y gastric bypass.; Procedure: Standard Roux-en-Y gastric bypass

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Hospital General Tlahuac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long biliopancreatic limb; Patients submitted to long biliopancreatic limb Roux-en-Y gastric bypass.	Procedure: Long biliopancreatic limb Roux-en-Y gastric bypass.; Long biliopancreatic limb Roux-en-Y gastric bypass.
Active Comparator: Standard biliopancreatic limb; Patients submitted to standard Roux-en-Y gastric bypass.	Procedure: Standard Roux-en-Y gastric bypass; Standard Roux-en-Y gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Measures: Weight in kilograms	12 months
Weight loss	Measures: Body Mass Index	12 months
Weight loss	Measures: Percent of excess weight loss	12 months
Weight loss	Measures: Percent of total weight loss	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Diabetes Remission Rate	Measures: No need for anti-diabetics while on glucose <100 mg/dl and HbA1c% <6	12 months
Major early complications	Measure: Rate of re-operations and re-admissions	First 30 days
Major late complications	Measure: Rate of re-operations and re-admisions	2-12 months
Nutritional status	Measure: serum albumin (gr/dL)	12 months
Nutritional status	Measure: serum total proteins (gr/dL)	12 months
Nutritional status	Measure: hemoglobin (g/dL)	12 months

Collaborators and Investigators

• Sponsor: CARLOS ZERRWECK LOPEZ
• Investigators: Study Director: Carlos Zerrweck, MD, Head of Department. The Obesity Clinic at Hospital General Tlahuac; Principal Investigator: Antonio Herrera, MD, The Obesity Clinic at Hospital General Tlahuac

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CZL-030619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No