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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00821197
First Posted: January 13, 2009
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Hospital of Vestfold
Information provided by (Responsible Party):
Tom Mala, Oslo University Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by Tom Mala, Oslo University Hospital:

Primary Outcome Measures:
  • Primary outcome: weight loss [ Time Frame: 2 (and 5) years postoperatively ]

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 ]

Enrollment: 115
Study Start Date: February 2011
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 12, 2009
First Posted: January 13, 2009
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Tom Mala, Oslo University Hospital:
obesity
laparoscopy
bariatric
super obesity

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