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Clinical Trials/NCT00821197
NCT00821197
Active, not recruiting
Not Applicable

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

Oslo University Hospital1 site in 1 country115 target enrollmentFebruary 2011
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ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Oslo University Hospital
Enrollment
115
Locations
1
Primary Endpoint
Primary outcome: weight loss
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Technical data will later be published in detail

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
May 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tom Mala

Principal investigator Surgeon phd Tom Mala Rune Sandbu

Oslo University Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Primary outcome: weight loss

Time Frame: 2 years postoperatively

physical examination

Secondary Outcomes

  • Health related Quality of life(10 years postoperative)
  • Secondary outcome: Quality of life(2 years postoperative)
  • Adverse events(10 years postoperative)
  • Number of patients with vitamin deficiencies(10 years postoperative)
  • Number of patients with mineral deficiencies(10 years postoperative)
  • Number of participants with malnutrition(2 years postoperative)
  • Weight loss 5 year(5 year postoperative)
  • Number of patients with malnutrition(10 years postoperative)
  • Weight loss 10 years(10 years postoperative)

Study Sites (1)

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