Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study
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Purpose
Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.
The investigators want to compare the effects between preventing a proximal (oral) portion of the jejunum from food contact with the effects when preventing the jejunum from contact with bile and pancreatic juice.
Endpoints are quality of life, gstrointestinal function, and weight development.
| Condition | Intervention |
|---|---|
|
Morbid Obesity Weight Loss |
Procedure: gastric bypass |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity |
- body weight reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]absolute BW reduction, percentage of patients reaching BMI below 30,
- gastrointestinal function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard length bp limb, long alimentary limb
our normal way of doing a gastric bypass
|
Procedure: gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
|
| Experimental: Long BP limb |
Procedure: gastric bypass
two techniques of gastric bypass for studying the effects of making a long BP-limb
|
Detailed Description:
Two variations of gastric bypass are compared:
Method 1:A 200 cm BP-limb (distance Treitz to EA)+ 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2: A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable. Patients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.
FU time is set at 5 years.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- BMI 50-65
- Age 18-55
- Conservative attempts at weight reduction failed
Exclusion Criteria:
- Inability to speak and understand the Swedish language
- Residence outside the county of Skåne
- Psychotic disease
- Inflammatory bowel disease
Contacts and Locations| Contact: Hjortur Gislason, MD, PhD | +4748891375 | hjortur.gislason@aleris.no |
| Contact: Jan L Hedenbro, MD, PhD | +46705132572 | jan.hedenbro@aleris.se |
| Sweden | |
| Aleris Obesity Skåne | Recruiting |
| Lund, Sweden, SE 222 70 | |
| Contact: Jan L Hedenbro, MD PhD +46705132572 jan.hedenbro@aleris.se | |
| Principal Investigator: Hjortur Gislason, MD PhD | |
More Information
No publications provided
| Responsible Party: | Aleris Obesity |
| ClinicalTrials.gov Identifier: | NCT01514799 History of Changes |
| Other Study ID Numbers: | 2011_HG_Aleris_limb_length |
| Study First Received: | January 18, 2012 |
| Last Updated: | January 20, 2012 |
| Health Authority: | Sweden: Etikprövningsnämnden i Lund |
Keywords provided by Aleris Obesity:
|
gastric bypass morbid obesity gut function weight loss |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Weight Loss Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on June 17, 2013