ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01084915
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 6, 2014
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Jens Homan, Rijnstate Hospital

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.


Condition or disease
Weight Loss

Study Type : Observational
Actual Enrollment : 840 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Results and Outcomes of the SAGB-VC in a High Volume Bariatric Centre
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Weight loss [ Time Frame: 2 months ]
    The amount of weight loss over time is researched


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jens Homan, MD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT01084915     History of Changes
Other Study ID Numbers: 680-070110-Aarts
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014

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

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