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

This study has been completed.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT01084915
First received: March 10, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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
Weight Loss

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre

Resource links provided by NLM:


Further study details as provided by Rijnstate Hospital:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The amount of weight loss over time is researched


Secondary Outcome Measures:
  • Bariatric Analysis and Reporting Outcome System (BAROS) score [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    A specific score for quality of life (QOL) and outcome for bariatric surgery is inventorized

  • Operating time [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Operating time is inventorized

  • Complications [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Complications are inventorized

  • Co-morbidities [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The reduction of co-morbidities is inventorized


Enrollment: 840
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who received a SAGB-VC band from 2004-2008

Criteria

Inclusion Criteria:

  • SAGB band placed from 2004-2008

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084915

Locations
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
Sponsors and Collaborators
Rijnstate Hospital
Ethicon, Inc.
Investigators
Principal Investigator: F.J. Berends, MD, PhD Rijnstate Hospital The Netherlands
  More Information

No publications provided

Responsible Party: Jens Homan, MD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01084915     History of Changes
Other Study ID Numbers: 680-070110-Aarts
Study First Received: March 10, 2010
Last Updated: March 5, 2014
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Rijnstate Hospital:
Weight loss after SAGB VC band placement

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014