A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

Not Applicable

Completed

• Conditions: Bariatric Surgery; Metabolic Surgery; Roux-en-Y Gastric Bypass
• Interventions: Procedure: Long biliopancreatic limb Roux-en-Y gastric bypass.; Procedure: Standard Roux-en-Y gastric bypass

• Registration Number: NCT04609449
• Lead Sponsor: CARLOS ZERRWECK LOPEZ

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long biliopancreatic limb	Long biliopancreatic limb Roux-en-Y gastric bypass.	Patients submitted to long biliopancreatic limb Roux-en-Y gastric bypass.
Standard biliopancreatic limb	Standard Roux-en-Y gastric bypass	Patients submitted to standard Roux-en-Y gastric bypass.

Primary Outcome Measures

Name	Time	Method
Weight loss	12 months	Measures: Percent of total weight loss

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Tlahuac; 🇲🇽 Mexico City, Mexico