The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC) (ROS)

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01084915
First received: March 10, 2010
Last updated: March 5, 2014
Last verified: March 2014

March 10, 2010
March 5, 2014
March 2010
June 2011   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 2 months ] [ Designated as safety issue: No ]
The amount of weight loss over time is researched
Weight loss [ Time Frame: 2 months ] [ Designated as safety issue: No ]
The ammount of weight loss over time is researched
Complete list of historical versions of study NCT01084915 on ClinicalTrials.gov Archive Site
  • Bariatric Analysis and Reporting Outcome System (BAROS) score [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized
  • Operating time [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Operating time is inventorized
  • Complications [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Complications are inventorized
  • Co-morbidities [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The reduction of co-morbidities is inventorized
Same as current
Not Provided
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The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC)
The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre

Since a few years the SAGB-VC is used in our clinic. This type of band has a number of advantages when compared to the earlier versions of the adjustable gastric band (AGB), reducing the chances on leakage, tube disconnection and port problems. In our clinic the follow up is strict. All patients are required to follow a special follow-up program in which the patient is seen 19 times during the first two years after SAGB-VC placement.

This is the first retrospective clinical study of a large study population of >800 patients in which a SAGB-VC was placed. This study was conducted to evaluate the results and the efficiency of the SAGB-VC in our clinic.

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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Probability Sample

Patients who received a SAGB-VC band from 2004-2008

Weight Loss
Not Provided
SAGB VC group
Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
July 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • SAGB band placed from 2004-2008

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01084915
680-070110-Aarts
No
Jens Homan, Rijnstate Hospital
Rijnstate Hospital
Ethicon, Inc.
Principal Investigator: F.J. Berends, MD, PhD Rijnstate Hospital The Netherlands
Rijnstate Hospital
March 2014

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