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

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ClinicalTrials.gov Identifier: NCT00821197
Recruitment Status : Active, not recruiting
First Posted : January 13, 2009
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
The Hospital of Vestfold
Information provided by (Responsible Party):
Tom Mala, Oslo University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Obesity Procedure: long-limb gastric bypass Procedure: distal gastric bypass Not Applicable

Detailed Description:
Technical data will later be published in detail

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
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
Study Start Date : February 2011
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2025

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Primary outcome: weight loss [ Time Frame: 2 years postoperatively ]
    physical examination


Secondary Outcome Measures :
  1. Secondary outcome: Quality of life [ Time Frame: 2 years postoperative ]
    questionnaire

  2. Adverse events [ Time Frame: 2 years postoperative ]
    medical history, journals

  3. Number of patients with vitamin deficiencies [ Time Frame: 2 years postoperative ]
    Blood samples

  4. Number of patients with mineral deficiencies [ Time Frame: 2 years postoperative ]
    Blood samples

  5. Number of participants with malnutrition [ Time Frame: 2 years postoperative ]
    Blood samples

  6. Weight loss 5 year [ Time Frame: 5 year postoperative ]
    physical examination

  7. Quality of life [ Time Frame: 5 years postoperative ]
    questionnaire

  8. Number of patients with malnutrition [ Time Frame: 5 years postoperative ]
    Blood samples

  9. Number of patients with mineral deficiencies [ Time Frame: 5 years postoperative ]
    Blood samples

  10. Number of patients with vitamin deficiencies [ Time Frame: 5 years postoperative ]
    Blood samples

  11. Adverse events [ Time Frame: 5 years ]
    Medical history, journals

  12. Weight loss 10 years [ Time Frame: 10 years postoperative ]
    Weight measure

  13. Adverse events [ Time Frame: 10 years postoperative ]
    Medical history, journals

  14. Number of patients with malnutrition [ Time Frame: 10 years postoperative ]
    Blood samples

  15. Number of patients with mineral deficiencies [ Time Frame: 10 years postoperative ]
    Blood samples

  16. Number of patients with vitamin deficiencies [ Time Frame: 10 years postoperative ]
    Blood samples

  17. Quality of life [ Time Frame: 10 years postoperative ]
    questionnaire



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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)

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, Norway, 0514
Sponsors and Collaborators
Oslo University Hospital
The Hospital of Vestfold
Investigators
Study Chair: Tom Mala MD, PhD Rune Sandbu, MD, PhD Aker University Hospital / The Hospital of Vestfold

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tom Mala, Principal investigator Surgeon phd Tom Mala Rune Sandbu, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00821197     History of Changes
Other Study ID Numbers: AT-0910-ST
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

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