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Swedish Adjustable Gastric Banding Observational Cohort Study

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.
 
ClinicalTrials.gov Identifier: NCT01183975
Recruitment Status : Completed
First Posted : August 18, 2010
Results First Posted : August 7, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Obesity, Morbid
Enrollment 517
Recruitment Details The cohort consisted of 517 cases of the SAGB implanted by 31 surgeons recruited between 02 SEPT 2007 and 30 April 2008.
Pre-assignment Details  
Arm/Group Title Patients Treated With SAGB by Solicited Teams
Hide Arm/Group Description Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Period Title: Overall Study
Started 517
Completed 444
Not Completed 73
Reason Not Completed
Lost to Follow-up             73
Arm/Group Title Patients Treated With SAGB by Solicited Teams
Hide Arm/Group Description Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Overall Number of Baseline Participants 517
Hide Baseline Analysis Population Description
a longitudinal prospective cohort study of consecutive patients treated with SAGB in a representative sample of centers for this activity in France.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 517 participants
37.5  (10.92)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
Female 455
Male 61
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 517 participants
517
Patients treated with SAGB by solicited teams  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 517 participants
517
1.Primary Outcome
Title Mean BMI Change
Hide Description Mean change in BMI for valid subjects
Time Frame 3 years follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
517 valid patients analyzed
Arm/Group Title Patients Treated With SAGB by Solicited Teams
Hide Arm/Group Description:
Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Overall Number of Participants Analyzed 517
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-9.03  (5.31)
2.Primary Outcome
Title Mean Excess Weight Change
Hide Description Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).
Time Frame 3 years follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients Treated With SAGB by Solicited Teams
Hide Arm/Group Description:
Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Overall Number of Participants Analyzed 517
Mean (Standard Deviation)
Unit of Measure: percent change in excess weight
-45.76  (29.97)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients Treated With SAGB by Solicited Teams
Hide Arm/Group Description Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
All-Cause Mortality
Patients Treated With SAGB by Solicited Teams
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Patients Treated With SAGB by Solicited Teams
Affected / at Risk (%) # Events
Total   123/517 (23.79%)    
Gastrointestinal disorders   
Band Removal * [1]  67/517 (12.96%)  67
port re-interventions without port removal * [2]  22/517 (4.26%)  22
port removal * [3]  8/517 (1.55%)  8
band re-interventions without removal * [4]  3/517 (0.58%)  3
Skin and subcutaneous tissue disorders   
abdominoplasty * [5]  23/517 (4.45%)  23
*
Indicates events were collected by non-systematic assessment
[1]
Band Removal
[2]
port re-interventions without port removal
[3]
Port Removal
[4]
band re-interventions without removal
[5]
Abdominoplasty
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patients Treated With SAGB by Solicited Teams
Affected / at Risk (%) # Events
Total   26/517 (5.03%)    
Gastrointestinal disorders   
band-related: Slippage *  26/517 (5.03%)  26
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Birgit Temiz
Organization: Ethicon, Inc.
Phone: +49 (0) 40 5297 3144
EMail: btemiz@its.jnj.com
Layout table for additonal information
Responsible Party: Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier: NCT01183975     History of Changes
Other Study ID Numbers: 05-FR-004
First Submitted: August 17, 2010
First Posted: August 18, 2010
Results First Submitted: April 9, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 8, 2014