Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study

Study Overview
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Brief Summary
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Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. 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 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice. Endpoints are quality of life, gastrointestinal function, and weight development.

Detailed Description
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Two variations of gastric bypass are compared: Method 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): 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.

Official Title
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Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity

Conditions
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Morbid Obesity, Weight Loss

Intervention / Treatment
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* Procedure: gastric bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Interventional Model Description: Randomised study between long and standard biliopancreatic limb in gstric bypass surgery
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard length bp limb, long alimentary limb<br>our normal way of doing a gastric bypass 60 cm BP limb | Procedure: gastric bypass<br>* two techniques of gastric bypass for studying the effects of making a long BP-limb<br>|
| Experimental: Long BP limb<br>200 cm BP limb | Procedure: gastric bypass<br>* two techniques of gastric bypass for studying the effects of making a long BP-limb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight reduction | absolute BW reduction, percentage of patients reaching BMI below 30, | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal function | SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric bypass, morbid obesity, gut function, weight loss