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NCT Number: NCT01686997

Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

  • BMI 35 - 40 with a comorbidity
  • or BMI > 40

Redo- operation

  • medical history: gastric sleeve/ mason / gastric band
  • all BMI levels

Exclusion criteria

  • Exclusion criteria for bariatric surgery (Fried Guidelines)
  • Patients with language problems that interveins to follow medical advises
  • Genetic diseases that intervens to follow medical advises
  • Chronic bowel diseases
  • Nephrologic (MDRD <30) of liver diseases (AST/ALT more than twice the norm)
  • Pregnancy

Treatment and study plan

Roux-en-Y gastric bypass

Procedure

Primary outcomes

  1. Weight reduction

    Time frame: 2 years

    excess weight loss (%EWL)

Secondary outcomes

  1. Decrease in comorbidities

    Time frame: 2 years

    diabetes mellitus, hypertension, hypercholesterolemia, arthrosis

  2. Quality of life

    Time frame: 2 years

    SF-36 and BAROS

  3. Complications and re-operations

    Time frame: 2 years

    bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

'Effect of Long biLiopancrEatic Limb lenGth in lAparoscopic Roux-eN-Y Gastric Bypass on Weight Loss and Comorbidities in Patients With Morbid obEsity: a Prospective Randomized Control Trial'

Acronym: Elegance

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2012
Registry last updated
Jun 3, 2016

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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