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OpenTrials
Completed

NCT Number: NCT04609449

A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital General Tlahuac

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long biliopancreatic limb Roux-en-Y gastric bypass.

Procedure

Long biliopancreatic limb Roux-en-Y gastric bypass.

Standard Roux-en-Y gastric bypass

Procedure

Standard Roux-en-Y gastric bypass

Primary outcomes

  1. Weight loss

    Time frame: 12 months

    Measures: Weight in kilograms

  2. Weight loss

    Time frame: 12 months

    Measures: Body Mass Index

  3. Weight loss

    Time frame: 12 months

    Measures: Percent of excess weight loss

  4. Weight loss

    Time frame: 12 months

    Measures: Percent of total weight loss

Secondary outcomes

  1. Complete Diabetes Remission Rate

    Time frame: 12 months

    Measures: No need for anti-diabetics while on glucose <100 mg/dl and HbA1c% <6

  2. Major early complications

    Time frame: First 30 days

    Measure: Rate of re-operations and re-admissions

  3. Major late complications

    Time frame: 2-12 months

    Measure: Rate of re-operations and re-admisions

  4. Nutritional status

    Time frame: 12 months

    Measure: serum albumin (gr/dL)

  5. Nutritional status

    Time frame: 12 months

    Measure: serum total proteins (gr/dL)

  6. Nutritional status

    Time frame: 12 months

    Measure: hemoglobin (g/dL)

Sponsors and collaborators

Lead sponsor

CARLOS ZERRWECK LOPEZ

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 30, 2020
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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