Overview

This trial is active, not recruiting.

Condition obesity
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
long-limb gastric bypass
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
(Active Comparator)
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
distal gastric bypass
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Primary Outcomes

Measure
Primary outcome: weight loss
time frame: 2 (and 5) years postoperatively

Secondary Outcomes

Measure
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

Eligibility Criteria

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)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Oslo University Hospital.