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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014