Long-limb or Distal Gastric Bypass for Superobesity - Randomized Study
This trial is active, not recruiting.
|Treatments||long-limb gastric bypass, distal gastric bypass|
|Sponsor||University Hospital, Aker|
|Collaborator||The Hospital of Vestfold|
|Start date||February 2011|
|End date||May 2018|
|Trial size||115 participants|
|Trial identifier||NCT00821197, AT-0910-ST|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Primary outcome: weight loss
time frame: 2 (and 5) years postoperatively
Secondary outcome: Quality of life, nutritional deficiencies, perioperative outcome, change in comorbidity, short and longterm complications, health economic considerations, vitamin and mineral deficiencies
time frame: 2 and 5 years postoperative
Male or female participants from 20 years up to 60 years old.
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)
|Official title||Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study|
|Description||Technical data will later be published in detail|
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