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NCT01084915 Clinical Trial

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

Weight Loss Clinical Trial

— ROS  

Official title:
The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01084915
Other study ID # 680-070110-Aarts
Secondary ID
Status Completed
Phase N/A
First received March 10, 2010
Last updated March 5, 2014
Start date March 2010
Est. completion date July 2011

Study information
Verified date March 2014
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: Independent Ethics Committee
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 840
Est. completion date July 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- SAGB band placed from 2004-2008

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Rijnstate Hospital Arnhem Gelderland

Sponsors (2)
Lead Sponsor Collaborator
Rijnstate Hospital Ethicon, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss The amount of weight loss over time is researched 2 months No
Secondary Bariatric Analysis and Reporting Outcome System (BAROS) score A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized 2 months No
Secondary Operating time Operating time is inventorized 2 months No
Secondary Complications Complications are inventorized 2 months No
Secondary Co-morbidities The reduction of co-morbidities is inventorized 2 months No
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