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Trial registered on ANZCTR


Registration number
ACTRN12611000279921
Ethics application status
Approved
Date submitted
1/12/2010
Date registered
16/03/2011
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ten year follow-up of a prospective randomized controlled comparison of best practice medical management versus placement of the Lap-Band System to effect weight loss (ACTRN12605000113651)
Scientific title
Ten year follow-up of a prospective randomized controlled comparison of best practice medical management versus placement of the Lap-Band System to effect weight loss (ACTRN12605000113651)
Secondary ID [1] 253216 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 258745 0
Condition category
Condition code
Diet and Nutrition 258897 258897 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Aim: This study will be a 10 year follow-up of the RCT conducted by this research group, assigned a registration number ACTRN12605000113651, registered 9/08/2005.

Randomisation details: Obese patients were randomized to either the medical or surgical group. The medical arm received treatment with a VLCD plus ongoing individualized care encompassing other obesity drugs as determined and behaviour modification programs. The surgical arm received treatment with the Lap-Band System, a laparoscopic adjustable gastric band.
Timeline and method of data collection: Patients were initially followed for two years from randomization, and in this study we wish to extend this followup to ten years.
Data will be collected on all patients via telephone or in person contact. All outcomes including weight will be retaken as per the original protocol.
Intervention code [1] 257690 0
Not applicable
Comparator / control treatment
best practice medical management
Control group
Active

Outcomes
Primary outcome [1] 259754 0
Weight loss: weight in kilograms will be assessed at normal clinic visits.
Timepoint [1] 259754 0
At 10 years (original trial = 2 years)
Secondary outcome [1] 268515 0
Functional status changes
Timepoint [1] 268515 0
Measured by SF36, Beck Depression Inventory and Multidimensional Body-Self Relation Questionnaire)
At 10 years (originally 12 and 24 months )

Eligibility
Key inclusion criteria
All patients will be included in the 10 yr follow-up:

BMI 30-35, have identifiable problems either medical, physical or psychosocial with this level of obesity, be able to understand the options, the potential benefits and risks, and be able to comply with the requirements of each program.
Minimum age
20 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of acceptance of the randomization process, history of previous abdominal surgery which would potentially preclude the laparoscopic placement of the band, medical issues which contra-indicated either arm of the study including acute myocardial infarction within the past 6 months, dementia, active psychosis, concurrent experimental drug use, autoimmune disease, pregnancy, lactation, illicit drug use, excessive alcohol intake, use of drugs known to affect body composition, cytotoxic drugs, internal malignancy or major organ failure, inability to understand the risks, unrealistic expectation of benefits or likelihood of failure to comply with the follow up requirements of either program.

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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 258163 0
University
Name [1] 258163 0
Monash University
Address [1] 258163 0
The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country [1] 258163 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Applied Medical
Address
1/32 Windorah St
P.O Box 1545,
Stafford City 4053. Qld
Country
Australia
Secondary sponsor category [1] 257337 0
Commercial sector/Industry
Name [1] 257337 0
Inamed Health
Address [1] 257337 0
5540 Ekwill Street
Santa Barbara, California, USA 93111
Country [1] 257337 0
United States of America
Other collaborator category [1] 251708 0
Commercial sector/Industry
Name [1] 251708 0
Novartis
Address [1] 251708 0
327 -333 Police Rd
Mulgrave 3170
Country [1] 251708 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260147 0
The Avenue Hospital
Ethics committee address [1] 260147 0
The Avenue
Windsor Vic 3181
Ethics committee country [1] 260147 0
Australia
Date submitted for ethics approval [1] 260147 0
Approval date [1] 260147 0
06/01/2000
Ethics approval number [1] 260147 0
Trial 027
Ethics committee name [2] 260148 0
Alfred Hospital
Ethics committee address [2] 260148 0
Commercial Road
Melbourne Vic 3004
Ethics committee country [2] 260148 0
Australia
Date submitted for ethics approval [2] 260148 0
Approval date [2] 260148 0
06/01/2000
Ethics approval number [2] 260148 0
166/99
Ethics committee name [3] 260149 0
Monash University
Ethics committee address [3] 260149 0
Building 3D, Clayton Campus
Wellington Road
Clayton
Ethics committee country [3] 260149 0
Australia
Date submitted for ethics approval [3] 260149 0
Approval date [3] 260149 0
11/11/2003
Ethics approval number [3] 260149 0
2003/458MC

Summary
Brief summary
The primary purpose of this study is to compare best practice medical management versus placement of the Lap-Band System, mostly in terms of weight loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31975 0
Prof Wendy Brown
Address 31975 0
Centre for Obesity Research and Education
Level 6
The Alfred Centre
99 Commercial Rd
Melbourne. VIC 3004
Country 31975 0
Australia
Phone 31975 0
+61 3 99030724
Fax 31975 0
Email 31975 0
Wendy.Brown@monash.edu
Contact person for public queries
Name 15222 0
Ms Ms Cheryl Laurie
Address 15222 0
Centre for Obesity Research and Education (CORE) Monash University Medical School Alfred Hospital 99 Commercial Road Melbourne VIC 3004
Country 15222 0
Australia
Phone 15222 0
+61 3 99030721
Fax 15222 0
Email 15222 0
cheryl.laurie@med.monash.edu.au
Contact person for scientific queries
Name 6150 0
Ms Ms Cheryl Laurie
Address 6150 0
Centre for Obesity Research and Education (CORE) Monash University Medical School Alfred Hospital 99 Commercial Road Melbourne VIC 3004
Country 6150 0
Australia
Phone 6150 0
+61 3 99030721
Fax 6150 0
Email 6150 0
cheryl.laurie@med.monash.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator,
What supporting documents are/will be available?
No other documents available
Summary results
No Results