A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

Bariatric Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609449
• Other study ID #: CZL-030619
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2020
• Source: Hospital General Tlahuac
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Metabolic Surgery
• Roux-en-Y Gastric Bypass

Intervention

Procedure:
• Long biliopancreatic limb Roux-en-Y gastric bypass.
Long biliopancreatic limb Roux-en-Y gastric bypass.
• Standard Roux-en-Y gastric bypass
Standard Roux-en-Y gastric bypass

Locations

Country	Name	City	State
Mexico	Hospital General Tlahuac	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
CARLOS ZERRWECK LOPEZ

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Measures: Weight in kilograms	12 months
Primary	Weight loss	Measures: Body Mass Index	12 months
Primary	Weight loss	Measures: Percent of excess weight loss	12 months
Primary	Weight loss	Measures: Percent of total weight loss	12 months
Secondary	Complete Diabetes Remission Rate	Measures: No need for anti-diabetics while on glucose <100 mg/dl and HbA1c% <6	12 months
Secondary	Major early complications	Measure: Rate of re-operations and re-admissions	First 30 days
Secondary	Major late complications	Measure: Rate of re-operations and re-admisions	2-12 months
Secondary	Nutritional status	Measure: serum albumin (gr/dL)	12 months
Secondary	Nutritional status	Measure: serum total proteins (gr/dL)	12 months
Secondary	Nutritional status	Measure: hemoglobin (g/dL)	12 months