Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study

Study Overview
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Brief Summary
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The main study objective: To evaluate long-limb gastric bypass (150 cm alimentary limb) vs. distal gastric bypass (common channel 150 cm) in the treatment of superobesity (BMI 50-60 kg/m2). The main study hypothesis: Distal bypass accomplish an estimated 10-20 % larger weightloss than long-limb gastric bypass 1 year after surgery. Patients subject to distal bypass have more gastrointestinal side effects and more extensive nutritional deficiences compared to long-limb gastric bypass.

Detailed Description
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Technical data will later be published in detail

Official Title
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Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study

Conditions
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Obesity

Intervention / Treatment
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* Procedure: long-limb gastric bypass
* Procedure: distal gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 50 - 60 kg/m2 at admission for evaluation for bariatric surgery BMI 48 - 62 kg/m2 at study inclusion informed consent scheduled for bariatric surgery Exclusion Criteria: previous bariatric surgery previous major abdominal surgery previous history or established urolithiasis viral hepatitis, liver cirrhosis of any kind factors making the patient not eligible to understand and commit to the study protocol (severe psychiatric disease or drug/narcotic abuse)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: long-limb bypass<br>Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb) | Procedure: long-limb gastric bypass<br>* Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)<br>|
| Active Comparator: Distal gastric bypass<br>Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb) | Procedure: distal gastric bypass<br>* Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: weight loss | physical examination | 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome: Quality of life | questionnaire | 2 years postoperative | 
| Adverse events | medical history, journals | 2 years postoperative | 
| Number of patients with vitamin deficiencies | Blood samples | 2 years postoperative | 
| Number of patients with mineral deficiencies | Blood samples | 2 years postoperative | 
| Number of participants with malnutrition | Blood samples | 2 years postoperative | 
| Weight loss 5 year | physical examination | 5 year postoperative | 
| Health related Quality of life | questionnaire | 5 years postoperative | 
| Number of patients with malnutrition | Blood samples | 5 years postoperative | 
| Number of patients with mineral deficiencies | Blood samples | 5 years postoperative | 
| Number of patients with vitamin deficiencies | Blood samples | 5 years postoperative | 
| Adverse events | Medical history, journals | 5 years | 
| Weight loss 10 years | Weight measure | 10 years postoperative | 
| Adverse events | Medical history, journals | 10 years postoperative | 
| Number of patients with malnutrition | Blood samples | 10 years postoperative | 
| Number of patients with mineral deficiencies | Blood samples | 10 years postoperative | 
| Number of patients with vitamin deficiencies | Blood samples | 10 years postoperative | 
| Health related Quality of life | questionnaire | 10 years postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, laparoscopy, bariatric, super obesity