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.
Technical data will later be published in detail
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
115
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Oslo, Norway
Primary outcome: weight loss
physical examination
Time frame: 2 years postoperatively
Secondary outcome: Quality of life
questionnaire
Time frame: 2 years postoperative
Adverse events
medical history, journals
Time frame: 2 years postoperative
Number of patients with vitamin deficiencies
Blood samples
Time frame: 2 years postoperative
Number of patients with mineral deficiencies
Blood samples
Time frame: 2 years postoperative
Number of participants with malnutrition
Blood samples
Time frame: 2 years postoperative
Weight loss 5 year
physical examination
Time frame: 5 year postoperative
Health related Quality of life
questionnaire
Time frame: 5 years postoperative
Number of patients with malnutrition
Blood samples
Time frame: 5 years postoperative
Number of patients with mineral deficiencies
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Blood samples
Time frame: 5 years postoperative
Number of patients with vitamin deficiencies
Blood samples
Time frame: 5 years postoperative
Adverse events
Medical history, journals
Time frame: 5 years
Weight loss 10 years
Weight measure
Time frame: 10 years postoperative
Adverse events
Medical history, journals
Time frame: 10 years postoperative
Number of patients with malnutrition
Blood samples
Time frame: 10 years postoperative
Number of patients with mineral deficiencies
Blood samples
Time frame: 10 years postoperative
Number of patients with vitamin deficiencies
Blood samples
Time frame: 10 years postoperative
Health related Quality of life
questionnaire
Time frame: 10 years postoperative