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)

Not Applicable

Withdrawn

• Conditions: Obesity; Diet and Nutrition - Obesity

• Registration Number: ACTRN12611000279921
• Lead Sponsor: Applied Medical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified