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Effects of Bariatric Surgery in Swedish Obese Subjects (SOS)

This study has been completed.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01479452
First received: November 22, 2011
Last updated: November 23, 2011
Last verified: November 2011

November 22, 2011
November 23, 2011
January 1987
November 2005   (final data collection date for primary outcome measure)
Overall mortality [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
The SOS study was started in 1987 and effect of bariatric surgery on overall mortality (primary endpoint) was reported in 2007. Cut off date for the analysis was November 1, 2005.
Same as current
Complete list of historical versions of study NCT01479452 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Bariatric Surgery in Swedish Obese Subjects
Effects of Bariatric Surgery in Swedish Obese Subjects

The purpose of the Swedish Obese Subjects (SOS) study is to examine the long-term effects of bariatric surgery on overall mortality and obesity-related co-morbidities.

The Swedish Obese Subjects (SOS) study is a prospective non-randomized controlled intervention study designed to examine the long-term effects of bariatric surgery compared to usual care in obese subjects.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
  • Procedure: Bariatric surgery
    Gastric banding, vertical banded gastroplasty, gastric bypass
  • Other: Usual care
    Non-surgical obesity treatment
  • Bariatric surgery
    Bariatric surgery
    Intervention: Procedure: Bariatric surgery
  • Controls
    Usual care
    Intervention: Other: Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4047
November 2005
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 37-60 years and BMI ≥34 kg/m2 in men and ≥38 kg/m2 in women.

Exclusion Criteria:

  • Exclusion criteria of both groups were: earlier operation for gastric or duodenal ulcer; earlier bariatric surgery
  • Gastric ulcer during the past 6 months; ongoing malignancy
  • Active malignancy during the past 5 years
  • Myocardial infarction during the past 6 months
  • Bulimic eating pattern; drug or alcohol (>0·75 L 40% liquor per week or corresponding amount of ethanol) abuse
  • Psychiatric or cooperative problems contraindicating bariatric surgery
  • Other contraindicating conditions (such as continuous glucocorticoid or anti-inflammatory treatment).
Both
37 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01479452
SOS-1987
Yes
Göteborg University
Göteborg University
The Swedish Research Council
Principal Investigator: Lena MS Carlsson, MD, PhD Göteborg University
Göteborg University
November 2011

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