Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000416493
Ethics application status
Approved
Date submitted
29/07/2007
Date registered
17/08/2007
Date last updated
17/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical experience of laparoscopic adjustable gastric banding in a public hospital setting to achieve weight loss in morbidly obese patients
Scientific title
Patients having laparoscopic adjustable gastric banding for obesity and their long term results with respect to weight loss in morbidly obese patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity surgery 2197 0
Condition category
Condition code
Diet and Nutrition 2291 2291 0 0
Obesity
Surgery 2292 2292 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Laparoscopic adjustable gastric banding.This is a permanent procedure which already takes place in the hospital and I am just auditing the results. The procedure involves the laparoscopic placement of an adjustable gastric band around the proximal stomach. This is an observational study. Patients will fill in a questionnaire relating to their weight loss and co-morbidty status. The method of assessment/collation is a questionnaire. Auditing will occur yearly for 5 years.
Intervention code [1] 1912 0
Treatment: Surgery
Comparator / control treatment
There is no control group as it is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3182 0
Weight loss.
Timepoint [1] 3182 0
Checked yearly for 5 years
Secondary outcome [1] 5308 0
Improvement of co-morbidities of obesity. We will be measuring diabetes, hypertension and hypercholesterolaema.
Timepoint [1] 5308 0
Checked yearly for 5 years.

Eligibility
Key inclusion criteria
All patients having surgery for obesity in Sir Charles Gairdner hospital. Inclusion criteria: If they are having the operation or have had the operation, they can be included in the study.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they are blind or illiterate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2455 0
Hospital
Name [1] 2455 0
Sir Charles Gairdner Hospital
Country [1] 2455 0
Australia
Primary sponsor type
Individual
Name
Jeremy Tan
Address
PO Box 3057
Broadway
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 2227 0
None
Name [1] 2227 0
There are no secondary sponsors
Address [1] 2227 0
Country [1] 2227 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4320 0
Sir Charles Gairdner Hospital
Ethics committee address [1] 4320 0
Ethics committee country [1] 4320 0
Date submitted for ethics approval [1] 4320 0
Approval date [1] 4320 0
Ethics approval number [1] 4320 0

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

Contacts
Principal investigator
Name 27726 0
Address 27726 0
Country 27726 0
Phone 27726 0
Fax 27726 0
Email 27726 0
Contact person for public queries
Name 11101 0
Jeremy Tan
Address 11101 0
Department of General Surgery
Sir Charles Gairdner Hospital
1 Hospital Ave
Nedlands WA 6009
Country 11101 0
Australia
Phone 11101 0
+61 8 93463333
Fax 11101 0
Email 11101 0
jthtan@it.net.au
Contact person for scientific queries
Name 2029 0
Jeremy Tan
Address 2029 0
Department of General Surgery
Sir Charles Gairdner Hospital
1 Hospital Ave
Nedlands WA 6009
Country 2029 0
Australia
Phone 2029 0
+61 8 93463333
Fax 2029 0
Email 2029 0
jthtan@it.net.au

No information has been provided regarding IPD availability


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.