A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

Study Overview
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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.

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

Conditions
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Bariatric Surgery, Metabolic Surgery, Roux-en-Y Gastric Bypass

Intervention / Treatment
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* Procedure: Long biliopancreatic limb Roux-en-Y gastric bypass.
* Procedure: Standard Roux-en-Y gastric bypass


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |