The Results and Outcomes of the Modified Swedish Adjustable Gastric Band (SAGB-VC) (ROS)
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|ClinicalTrials.gov Identifier: NCT01084915|
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 6, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||840 participants|
|Official Title:||The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||July 2011|
SAGB VC group
Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken.
- Weight loss [ Time Frame: 2 months ]The amount of weight loss over time is researched
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084915
|Arnhem, Gelderland, Netherlands, 6800 TA|
|Principal Investigator:||F.J. Berends, MD, PhD||Rijnstate Hospital The Netherlands|