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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Hospital of Vestfold
Information provided by (Responsible Party):
Tom Mala, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00821197
First received: January 12, 2009
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Obesity
Procedure: long-limb gastric bypass
Procedure: distal gastric bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long -Limb Gastric or Distal Gastric Bypass in the Treatment of Super Obese Patients - a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Primary outcome: weight loss [ Time Frame: 2 (and 5) years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: February 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: long-limb bypass
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Procedure: long-limb gastric bypass
Laparoscopic long-limb gastric bypass (150 cm alimentary limb, 50 cm biliopancreatic limb)
Active Comparator: Distal gastric bypass
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)
Procedure: distal gastric bypass
Laparoscopic distal gastric bypass (150 cm common channel, 50 cm biliopancreatic limb)

Detailed Description:

Technical data will later be published in detail

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821197

Locations
Norway
Aker university Hospital, Surgical Dep., The Hospital of Vestfold, Surgical Dep.
Oslo and Tønsberg, Norway, Oslo/Tønsberg, Norway, 0514/3103
Sponsors and Collaborators
University Hospital, Aker
The Hospital of Vestfold
Investigators
Study Chair: Tom Mala MD, PhD Rune Sandbu, MD, PhD Aker University Hospital / The Hospital of Vestfold
  More Information

Additional Information:
No publications provided

Responsible Party: Tom Mala, Tom Mala, surgeon phd/ Rune Sandbu, surgeon phd, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00821197     History of Changes
Other Study ID Numbers: AT-0910-ST
Study First Received: January 12, 2009
Last Updated: May 17, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
obesity
laparoscopy
bariatric
super obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014