Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bariatric Surgery on the West Coast of Norway (Vestlandet) (FatWest)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Helse Fonna.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Helse Førde
Helse-Bergen HF
Information provided by (Responsible Party):
Bjørn Gunnar Nedrebø, MD, PhD, Helse Fonna
ClinicalTrials.gov Identifier:
NCT01533142
First received: February 9, 2012
Last updated: February 11, 2012
Last verified: February 2012

February 9, 2012
February 11, 2012
February 2012
Not Provided
weight loss [ Time Frame: From 1 year and up to 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01533142 on ClinicalTrials.gov Archive Site
remission of diabetes mellitus type 2 [ Time Frame: from 1 year up to 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bariatric Surgery on the West Coast of Norway (Vestlandet)
Bariatric Surgery on the West Coast of Norway (Vestlandet): Prospective Study of Overweight People Undergoing Bariatric Surgery

Bariatric surgery of morbid obesity was first located at Førde Central Hospital, but it is now an established treatment at several other hospitals in the health region (Voss Hospital (Helse Bergen), Haugesund Hospital (Helse Fonna) Stavanger University Hospital ((SUS) Helse Stavanger). Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy . The investigators have then in Helse-Vest a unique opportunity to examine the various clinical and metabolic effects from different surgical methods.

This project is part of the regional strategic research initiative in the Helse Vest

Primary endpoints for the study are weight loss and self-reported quality of life (QoL) evaluated by Short Form (SF)-36 and Impact of Weight Wed Quality of Life-Lite (IWQOL-Lite)) Our hypothesis is that patients operated with RYGBP (Roux A-Y Gastric Bypass) and BPD / DS (biliopancreatic diversion with duodenal switch) have the same weight and same QoL after 5 years of follow-up as patients treated with gastric sleeve (laparoscopic gastric sleeve (LSG)) We will also compare the groups with respect to a number of secondary endpoints

400 patients (approximately 100 patients / institution) will be included in the main study. Some of the programs that run on secondary endpoints will be conducted separately under study at each hospital. These studies will be reported in separate articles.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma, serum, urine and biopsi from fat

Probability Sample

Both sexes 18-60 years old Patients with morbid obesity that is applied to the bariatric surgery. Signed informed consent

  • Weight Loss
  • Diabetes Mellitus
  • Urinary Incontinence
  • Procedure: Bariatric surgery

    Patients will be treated with one of two bariatric procedure::

    sleeve gastrectomy or gastric bypass

  • Procedure: Bariatric surgery
    Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy
  • surgical methods
    Different methods are used among hospitals in Helse-Vest, and this allows us to compare different clinical and biological effects following bariatric surgery different methods) among a homogeneous population in the western part of Norway (Vestlandet
    Interventions:
    • Procedure: Bariatric surgery
    • Procedure: Bariatric surgery
  • Morbid obesity
    Interventions:
    • Procedure: Bariatric surgery
    • Procedure: Bariatric surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
Not Provided

Inclusion Criteria:

  • Both sexes 18-60 years old
  • Patients with morbid obesity that is applied to the bariatric surgery.
  • Signed informed consent

Exclusion Criteria:

  • Patients who become pregnant in the follow-up period will not continue in the study but the data will be treated as lost too follow up.
Both
18 Years to 60 Years
No
Contact: Bjorn Gunnar Nedrebo, MD,PhD +4792226845 bned@helse-fonna.no
Contact: Per Espen Hovde-Hansen, MD ?47 52732000
Norway
 
NCT01533142
2010/3287
No
Bjørn Gunnar Nedrebø, MD, PhD, Helse Fonna
Helse Fonna
  • Helse Førde
  • Helse-Bergen HF
Not Provided
Helse Fonna
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP