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

Overview

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.

Full Title of Study: “The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2011

Arms, Groups and Cohorts

  • SAGB VC group
    • Retrospectively patients with a SAGB-VC gastric band are inventorized. They will also be interviewed and BAROS scores will be taken.

Clinical Trial Outcome Measures

Primary Measures

  • Weight loss
    • Time Frame: 2 months
    • The amount of weight loss over time is researched

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • SAGB band placed from 2004-2008 Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rijnstate Hospital
  • Collaborator
    • Ethicon, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jens Homan, MD – Rijnstate Hospital
  • Overall Official(s)
    • F.J. Berends, MD, PhD, Principal Investigator, Rijnstate Hospital The Netherlands

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