Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000137099
Ethics application status
Approved
Date submitted
18/01/2010
Date registered
10/02/2010
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Retrospective analysis of patient outcomes following surgical placement of the Swedish Adjustable Gastric Band-C (SAGB-VC) for the treatment of morbid obesity
Scientific title
Retrospective analysis of weight loss following surgical placement of the Swedish Adjustable Gastric Band-C (SAGB-VC) for the treatment of morbid obesity
Secondary ID [1] 1316 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 256592 0
Condition category
Condition code
Diet and Nutrition 256940 256940 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective audit of existing data in which we wish to analyse the efficacy and safety of the Swedish Adjustable Gastric Band (SAGB) in the treatment of morbid obesity over thw past 5 years. It is our intention to analyse follow-up data from those patients who have an SAGB.
Intervention code [1] 255876 0
Not applicable
Comparator / control treatment
There is no control group for this series of patients
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257634 0
Weight loss
Assessed by body mass index, body mass scales
Timepoint [1] 257634 0
Before and 12 months after surgery
Secondary outcome [1] 262905 0
Complications of surgery e.g. post operative infection on clinical assessment
Timepoint [1] 262905 0
Before and 12 months after surgery
Secondary outcome [2] 262968 0
Blood pressure measuerd using a sphygmomanometer
Timepoint [2] 262968 0
Before and 12 months after surgery
Secondary outcome [3] 262969 0
Fasting blood lipids and glucose measured at a certified commercial laboratory
Timepoint [3] 262969 0
Before and 12 months after surgery
Secondary outcome [4] 262970 0
Presence or absence of diabetes on clinical assessment
Timepoint [4] 262970 0
Before and 12 months after surgery
Secondary outcome [5] 262971 0
Presence or absence of hypertension on clinical assessment
Timepoint [5] 262971 0
Before and 12 months after surgery

Eligibility
Key inclusion criteria
National Health & Medical Research Council (NHMRC) criteria for surgery of body mass index (BMI) >35 kg/m2 with one or more co-morbidities or BMI greater than 40 kg/m2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand follow-up and operative procedures, untreated psychiatric disorders and alcohol and/or drug abuse

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
12/04/2010
Date of last participant enrolment
Anticipated
Actual
24/04/2011
Date of last data collection
Anticipated
Actual
29/06/2012
Sample size
Target
1200
Accrual to date
Final
1176
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 256340 0
Commercial sector/Industry
Name [1] 256340 0
Ethicon Endo-Surgery
Country [1] 256340 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Ethicon Endo-Surgery
Address
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242
Country
United States of America
Secondary sponsor category [1] 251680 0
None
Name [1] 251680 0
Address [1] 251680 0
Country [1] 251680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258412 0
Bellberry Ltd
Ethics committee address [1] 258412 0
Ethics committee country [1] 258412 0
Australia
Date submitted for ethics approval [1] 258412 0
20/01/2010
Approval date [1] 258412 0
24/03/2010
Ethics approval number [1] 258412 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30722 0
Address 30722 0
Country 30722 0
Phone 30722 0
Fax 30722 0
Email 30722 0
Contact person for public queries
Name 13969 0
Dr Jennifer Keogh
Address 13969 0
St Joseph's Cottage
Calvary Hospital
89 Strangways Terrace
NORTH ADELAIDE SA 5006
Country 13969 0
Australia
Phone 13969 0
+61 8 82671774
Fax 13969 0
+61 8 82673205
Email 13969 0
jennifer.keogh@internode.on.net
Contact person for scientific queries
Name 4897 0
Dr Jennifer Keogh
Address 4897 0
St Joseph's Cottage
Calvary Hospital
89 Strangways Terrace
NORTH ADELAIDE SA 5006
Country 4897 0
Australia
Phone 4897 0
+61 8 82671774
Fax 4897 0
+61 8 82673205
Email 4897 0
jennifer.keogh@internode.on.net

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.