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

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. Identifier: NCT01084915
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 6, 2014
Ethicon, Inc.
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital

March 10, 2010
March 11, 2010
March 6, 2014
March 2010
June 2011   (Final data collection date for primary outcome measure)
Weight loss [ Time Frame: 2 months ]
The amount of weight loss over time is researched
Weight loss [ Time Frame: 2 months ]
The ammount of weight loss over time is researched
Complete list of historical versions of study NCT01084915 on Archive Site
  • Bariatric Analysis and Reporting Outcome System (BAROS) score [ Time Frame: 2 months ]
    A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized
  • Operating time [ Time Frame: 2 months ]
    Operating time is inventorized
  • Complications [ Time Frame: 2 months ]
    Complications are inventorized
  • Co-morbidities [ Time Frame: 2 months ]
    The reduction of co-morbidities is inventorized
Same as current
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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 Model: Case-Only
Time Perspective: Retrospective
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Probability Sample
Patients who received a SAGB-VC band from 2004-2008
Weight Loss
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SAGB VC group
Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken.
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • SAGB band placed from 2004-2008

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Jens Homan, Rijnstate Hospital
Rijnstate Hospital
Ethicon, Inc.
Principal Investigator: F.J. Berends, MD, PhD Rijnstate Hospital The Netherlands
Rijnstate Hospital
March 2014