Swedish Adjustable Gastric Banding Observational Cohort Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier:
NCT01183975
First received: August 17, 2010
Last updated: August 6, 2014
Last verified: August 2014
Results First Received: April 9, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Obesity, Morbid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Patients Treated With SAGB by Solicited Teams 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.

Participant Flow:   Overall Study
    Patients Treated With SAGB by Solicited Teams  
STARTED     517  
COMPLETED     444  
NOT COMPLETED     73  
Lost to Follow-up                 73  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
a longitudinal prospective cohort study of consecutive patients treated with SAGB in a representative sample of centers for this activity in France.

Reporting Groups
  Description
Patients Treated With SAGB by Solicited Teams 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.

Baseline Measures
    Patients Treated With SAGB by Solicited Teams  
Number of Participants  
[units: participants]
  517  
Age  
[units: years]
Mean ± Standard Deviation
  37.5  ± 10.92  
Gender  
[units: participants]
 
Female     455  
Male     61  
Region of Enrollment  
[units: participants]
 
France     517  
Patients treated with SAGB by solicited teams  
[units: participants]
  517  



  Outcome Measures
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1.  Primary:   Mean BMI Change   [ Time Frame: 3 years follow-up ]

2.  Primary:   Mean Excess Weight Change   [ Time Frame: 3 years follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Birgit Temiz
Organization: Ethicon, Inc.
phone: +49 (0) 40 5297 3144
e-mail: btemiz@its.jnj.com


No publications provided


Responsible Party: Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier: NCT01183975     History of Changes
Other Study ID Numbers: 05-FR-004
Study First Received: August 17, 2010
Results First Received: April 9, 2014
Last Updated: August 6, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission