Trial Outcomes & Findings for Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program (NCT NCT01149512)

Results Overview

the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years

Recruitment status

COMPLETED

Target enrollment

178 participants

Primary outcome timeframe

baseline to 1 year, baseline to 2 years, baseline to 3 years

Results posted on

2017-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	LAGB Patients in Weight Wise Program All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
Overall Study STARTED	178
Overall Study COMPLETED	178
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LAGB Patients in Weight Wise Program n=178 Participants All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
Age, Continuous	42.8 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
initial BMI	44.2 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: baseline to 1 year, baseline to 2 years, baseline to 3 years

Population: Three patients' weight data were not included in the weight loss analysis owing to early removal of band (n = 1) and complication or pregnancy affecting weight (n = 2) before 1-year follow-up. 79 patients reached 2 year follow up time point and 38 patients reached 3 year follow up time point.

the percent total body weight loss between Baseline and 1 year the percent total body weight loss between Baseline and 2 years the percent total body weight loss between Baseline and 3 years

Outcome measures

Outcome measures
Measure	LAGB Patients in Weight Wise Program n=175 Participants All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
Mean Percentage Total Body Weight Loss Baseline to 1 year	15.8 % of total body weight loss Standard Deviation 7.6
Mean Percentage Total Body Weight Loss Baseline to 2 years	20.7 % of total body weight loss Standard Deviation 11
Mean Percentage Total Body Weight Loss Baseline to 3 years	20.3 % of total body weight loss Standard Deviation 10

SECONDARY outcome

Timeframe: baseline to 1 year, baseline to 2 years, baseline to 3 years

Population: 3 not included the same reason as above.

the percent of excess body weight loss between Baseline and 1 year the percent of excess body weight loss between Baseline and 2 years the percent of excess body weight loss between Baseline and 3 years

Outcome measures

Outcome measures
Measure	LAGB Patients in Weight Wise Program n=175 Participants All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
% of Excess Body Weight Loss Baseline to 1 year	34.1 % of excessive weight loss Standard Deviation 16
% of Excess Body Weight Loss Baseline to 2 years	44 % of excessive weight loss Standard Deviation 23
% of Excess Body Weight Loss Baseline to 3 years	43.4 % of excessive weight loss Standard Deviation 21

Adverse Events

LAGB Patients in Weight Wise Program

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LAGB Patients in Weight Wise Program n=178 participants at risk All patients seen within the Weight Wise program and selected for surgical management, who have undergone LAGB will be included in this analysis.
Gastrointestinal disorders postoperative nausea	19.1% 34/178 • Number of events 34 • 3-year follow-up
Surgical and medical procedures band migration	5.6% 10/178 • Number of events 10 • 3-year follow-up
Surgical and medical procedures port site complications	1.1% 2/178 • Number of events 2 • 3-year follow-up
Surgical and medical procedures band leakage	1.1% 2/178 • Number of events 2 • 3-year follow-up
Surgical and medical procedures incisional hernia	1.1% 2/178 • Number of events 2 • 3-year follow-up

Additional Information

Xinzhe Shi

Royal Alexandra Hospital

Phone: 7807356735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place