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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01084915
Acronym
ROS
Enrollment
840
Registered
2010-03-11
Start date
2010-03-31
Completion date
2011-07-31
Last updated
2014-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Loss

Keywords

Weight loss after SAGB VC band placement

Brief 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.

Interventions

None listed

Sponsors

Ethicon, Inc.
CollaboratorINDUSTRY
Rijnstate Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* SAGB band placed from 2004-2008

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Weight loss2 monthsThe amount of weight loss over time is researched

Secondary

MeasureTime frameDescription
Bariatric Analysis and Reporting Outcome System (BAROS) score2 monthsA specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized
Operating time2 monthsOperating time is inventorized
Complications2 monthsComplications are inventorized
Co-morbidities2 monthsThe reduction of co-morbidities is inventorized

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026