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

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Active, not recruiting

Conditions

Obesity

Treatments

Procedure: long-limb gastric bypass
Procedure: distal gastric bypass

Study type

Interventional

Funder types

Other

Identifiers

NCT00821197
AT-0910-ST

Details and patient eligibility

About

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.

Full description

Technical data will later be published in detail

Enrollment

115 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

115 participants in 2 patient groups

long-limb bypass
Active Comparator group
Description:
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Treatment:
Procedure: long-limb gastric bypass
Distal gastric bypass
Active Comparator group
Description:
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Treatment:
Procedure: distal gastric bypass

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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