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OpenTrials
Completed

NCT Number: NCT01084915

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

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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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital

Arnhem, Gelderland, 6800 TA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SAGB band placed from 2004-2008

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Weight loss

    Time frame: 2 months

    The amount of weight loss over time is researched

Secondary outcomes

  1. 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

  2. Operating time

    Time frame: 2 months

    Operating time is inventorized

  3. Complications

    Time frame: 2 months

    Complications are inventorized

  4. Co-morbidities

    Time frame: 2 months

    The reduction of co-morbidities is inventorized

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Collaborators

  • Ethicon, Inc.

Registry information

Official study title

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

Acronym: ROS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 11, 2010
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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