Trial Outcomes & Findings for Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2 (NCT NCT00580502)

Results Overview

Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

5 years

Results posted on

2015-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Lap-Band Low BMI patients who will go through Lap-band surgery. LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LAP-BAND® Adjustable Gastric Band (LAGB®) Operations n=50 Participants A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
BMI	35.1 kg/m2 STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: All participants who underwent LAGB are included in the analysis population.

Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.

Outcome measures

Outcome measures
Measure	LAGB n=46 Participants LAGB surgery for the patient whose BMI between 30 and 40 kg/m\^2
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery	51.74 percentage of excess weight loss Standard Deviation 27.36

SECONDARY outcome

Timeframe: 5 years

Population: All participants who underwent LAGB are included in the analysis population.

Change in level of LDL from baseline at 5 years

Outcome measures

Outcome measures
Measure	LAGB n=46 Participants LAGB surgery for the patient whose BMI between 30 and 40 kg/m\^2
Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery	117 mg/dl Standard Deviation 34

SECONDARY outcome

Timeframe: 5 years

Population: All participants who underwent LAGB and had 5 year follow up visit are included in the analysis population.

Change in level of Triglycerides from baseline at 5 years

Outcome measures

Outcome measures
Measure	LAGB n=46 Participants LAGB surgery for the patient whose BMI between 30 and 40 kg/m\^2
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery	103 mg/dl Standard Deviation 58

SECONDARY outcome

Timeframe: 5 years

Population: All participants who underwent LAGB and had 5 year f/u visit are included in the analysis population.

Change in level of HbA1c from baseline at 5 years

Outcome measures

Outcome measures
Measure	LAGB n=46 Participants LAGB surgery for the patient whose BMI between 30 and 40 kg/m\^2
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery	5.6 percentage of HbA1c Standard Deviation 0.6

Adverse Events

LAP-BAND® Adjustable Gastric Band (LAGB®) Operations

Serious events: 14 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LAP-BAND® Adjustable Gastric Band (LAGB®) Operations n=50 participants at risk A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
Surgical and medical procedures Band revision/replacement	28.0% 14/50 • Number of events 14 • Entire 5 years study period

Other adverse events

Other adverse events
Measure	LAP-BAND® Adjustable Gastric Band (LAGB®) Operations n=50 participants at risk A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
Surgical and medical procedures Port revision/replacement	8.0% 4/50 • Number of events 4 • Entire 5 years study period

Additional Information

Heekoung Youn

NYULMC

Phone: 2122632174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place