Morbid Obesity Clinical Trial
— EleganceOfficial 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'
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | April 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight reduction | excess weight loss (%EWL) | 2 years | No |
Secondary | Decrease in comorbidities | diabetes mellitus, hypertension, hypercholesterolemia, arthrosis | 2 years | No |
Secondary | Quality of life | SF-36 and BAROS | 2 years | No |
Secondary | Complications and re-operations | bleeding, wound infections, intra-abdominal abcess, anastomosis leakage, vitamine deficiencies | 2 years | Yes |
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