Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000113651
Ethics application status
Approved
Date submitted
6/08/2005
Date registered
9/08/2005
Date last updated
2/12/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The optimal treatment of obesity: a prospective randomized controlled comparison of best practice medical management versus placement of the Lap-Band System to effect weight loss.
Scientific title
The optimal treatment of obesity: a prospective randomized controlled comparison of best practice medical management versus placement of the Lap-Band System to effect weight loss.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 201 0
Condition category
Condition code
Diet and Nutrition 224 224 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Obese patients will be randomized to either the medical or surgical group. The medical arm will receive treatment with a VLCD plus ongoing individualized care encompassing other obesity drugs as determined and behaviour modification programs. The surgical arm will receive treatment with the Lap-Band System, a laparoscopic adjustable gastric band. Patients will be followed for two years from randomization.
Intervention code [1] 133 0
Treatment: Surgery
Comparator / control treatment
best practice medical management
Control group
Active

Outcomes
Primary outcome [1] 272 0
Weight loss.
Timepoint [1] 272 0
At 2 years.
Secondary outcome [1] 606 0
Body composition changes
Timepoint [1] 606 0
At 12 and 24 months
Secondary outcome [2] 607 0
Comorbidity changes
Timepoint [2] 607 0
At 12 and 24 months
Secondary outcome [3] 608 0
Functional status changes
Timepoint [3] 608 0
At 12 and 24 months measured by SF36, Beck Depression Inventory and Multidimensional Body-Self Relation Questionnaire.
Secondary outcome [4] 609 0
Side effects and economic evaluation.
Timepoint [4] 609 0
24 months

Eligibility
Key inclusion criteria
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
Sex
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 of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Intervention recorded and stored in numbered, sealed opaque envelopes organized and maintained by staff member not involved in patient care or scheduling and opened in sequence as randomized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 282 0
University
Name [1] 282 0
Monash University Department of Surgery
Country [1] 282 0
Australia
Funding source category [2] 283 0
Commercial sector/Industry
Name [2] 283 0
Applied Medical
Country [2] 283 0
Australia
Funding source category [3] 284 0
Commercial sector/Industry
Name [3] 284 0
Inamed Health
Country [3] 284 0
United States of America
Funding source category [4] 285 0
Commercial sector/Industry
Name [4] 285 0
Novartis
Country [4] 285 0
Australia
Funding source category [5] 286 0
Commercial sector/Industry
Name [5] 286 0
US Surgical
Country [5] 286 0
United States of America
Primary sponsor type
University
Name
Centre for Obesity Research and Education (CORE)
Address
Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 217 0
None
Name [1] 217 0
none
Address [1] 217 0
Country [1] 217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1136 0
The Avenue Hospital
Ethics committee address [1] 1136 0
Ethics committee country [1] 1136 0
Australia
Date submitted for ethics approval [1] 1136 0
Approval date [1] 1136 0
Ethics approval number [1] 1136 0
Trial 027
Ethics committee name [2] 1137 0
Alfred Hospital
Ethics committee address [2] 1137 0
Ethics committee country [2] 1137 0
Australia
Date submitted for ethics approval [2] 1137 0
Approval date [2] 1137 0
06/01/2000
Ethics approval number [2] 1137 0
166/99
Ethics committee name [3] 1138 0
Monash University SCERH
Ethics committee address [3] 1138 0
Ethics committee country [3] 1138 0
Australia
Date submitted for ethics approval [3] 1138 0
Approval date [3] 1138 0
11/11/2003
Ethics approval number [3] 1138 0
2003/458MC

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

Contacts
Principal investigator
Name 35217 0
Address 35217 0
Country 35217 0
Phone 35217 0
Fax 35217 0
Email 35217 0
Contact person for public queries
Name 9322 0
Ms Cheryl Laurie
Address 9322 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 9322 0
Australia
Phone 9322 0
+61 3 99030721
Fax 9322 0
+61 3 95103365
Email 9322 0
cheryl.laurie@med.monash.edu.au
Contact person for scientific queries
Name 250 0
Professor Paul O'Brien
Address 250 0
Centre for Obesity Research and Education (CORE)
Monash University Medical School
Alfred Hospital
Commercial Road
Melbourne VIC 3004
Country 250 0
Australia
Phone 250 0
+61 3 99030721
Fax 250 0
+61 3 95103365
Email 250 0
paul.obrien@med.monash.edu.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.