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)

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000279921

Enrollment

Registered

2011-03-16

Start date

2000-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Healthy volunteers

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.

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.

Outcome results