Trial Outcomes & Findings for LAGB as a Treatment for Morbid Obesity in Adolescents (NCT NCT01045499)
NCT ID: NCT01045499
Last Updated: 2020-04-13
Results Overview
Weight change evaluated in terms of % excess weight loss (EWL).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
137 participants
Primary outcome timeframe
Baseline and up to 5 years from start of study.
Results posted on
2020-04-13
Participant Flow
Adolescents aged 13 to 18 years were enrolled in this study.
The age range for the enrolled adolescents at the time of surgery was 14-19 years of age since some aged from the time of consent to surgery.
Participant milestones
| Measure |
Laparoscopic Gastric Banding
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
|
|---|---|
|
Overall Study
STARTED
|
137
|
|
Overall Study
COMPLETED
|
127
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LAGB as a Treatment for Morbid Obesity in Adolescents
Baseline characteristics by cohort
| Measure |
Adolescents With Morbid Obesity
n=137 Participants
At the time of enrollment, the adolescents with morbid obesity were aged 13-18 years of age and at the time of surgery, the adolescents were aged 14-19 years of age.
|
|---|---|
|
Age, Continuous
|
16.0 years
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
|
Family obesity
Mother
|
34 Participants
n=5 Participants
|
|
Family obesity
Father
|
14 Participants
n=5 Participants
|
|
Family obesity
Both
|
31 Participants
n=5 Participants
|
|
Family obesity
Yes (not identified)
|
6 Participants
n=5 Participants
|
|
Family obesity
Neither
|
50 Participants
n=5 Participants
|
|
Family obesity
Adopted (no information)
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to 5 years from start of study.Population: Includes individuals with confirmed band status at 5 years after surgery.
Weight change evaluated in terms of % excess weight loss (EWL).
Outcome measures
| Measure |
Laparoscopic Gastric Banding
n=127 Participants
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
|
|---|---|
|
Percentage of Excess Weight Change (EWL)
|
-35.5 percent change
Standard Deviation 39.4
|
SECONDARY outcome
Timeframe: Baseline and up to 5 years from start of study.Population: Includes individuals with confirmed band status at 5 years after surgery.
Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).
Outcome measures
| Measure |
Laparoscopic Gastric Banding
n=127 Participants
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
|
|---|---|
|
Percentage of Excess BMI Change
|
36.6 percent change
Standard Deviation 37.5
|
Adverse Events
Laparoscopic Gastric Banding
Serious events: 63 serious events
Other events: 137 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Laparoscopic Gastric Banding
n=137 participants at risk
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
|
|---|---|
|
Surgical and medical procedures
Band removal due to dysphagia, reflux or heartburn
|
2.2%
3/137 • Number of events 3 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Hiatal hernia repair
|
0.73%
1/137 • Number of events 1 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Gastric Herniation (band slippage)
|
7.3%
10/137 • Number of events 10 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Port site bleeding
|
0.73%
1/137 • Number of events 1 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Malpositioned band
|
0.73%
1/137 • Number of events 1 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Intestinal obstruction
|
0.73%
1/137 • Number of events 1 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Port displacement
|
8.0%
11/137 • Number of events 11 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Band removal
|
24.1%
33/137 • Number of events 33 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Weight loss procedure (conversion)
|
11.7%
16/137 • Number of events 16 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
Other adverse events
| Measure |
Laparoscopic Gastric Banding
n=137 participants at risk
Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values.
Laparoscopic adjustable gastric banding (Allergan Lap Band): Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.
|
|---|---|
|
Gastrointestinal disorders
Emesis
|
70.1%
96/137 • Number of events 266 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Gastrointestinal disorders
Abdominal pain
|
45.3%
62/137 • Number of events 114 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Port site pain
|
33.6%
46/137 • Number of events 73 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Gastrointestinal disorders
GERD/Heartburn
|
32.1%
44/137 • Number of events 68 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Metabolism and nutrition disorders
Dysphagia/food stuck
|
29.2%
40/137 • Number of events 76 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Infections and infestations
Upper respiratory infection (URI)
|
23.4%
32/137 • Number of events 40 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Gastrointestinal disorders
Diarrhea
|
13.1%
18/137 • Number of events 25 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Headaches
|
10.2%
14/137 • Number of events 16 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Sore throat
|
10.2%
14/137 • Number of events 15 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Back pain
|
8.8%
12/137 • Number of events 12 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Elevated CES-D Score
|
8.8%
12/137 • Number of events 12 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Band slip/prolapse
|
7.3%
10/137 • Number of events 14 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Surgical and medical procedures
Port displacement/flip
|
6.6%
9/137 • Number of events 10 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Dehydration
|
5.8%
8/137 • Number of events 8 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Knee pain
|
5.8%
8/137 • Number of events 11 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Metabolism and nutrition disorders
Esophagitis
|
5.8%
8/137 • Number of events 9 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
General disorders
Esophageal dilation
|
5.1%
7/137 • Number of events 9 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Infections and infestations
Sinusitis
|
5.1%
7/137 • Number of events 8 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
|
Infections and infestations
Fever
|
5.1%
7/137 • Number of events 7 • Adverse events were recorded as perioperative if occurring less than or equal to 30 days following surgery and post-operative if greater than 30 days. Safety data was collected up to 5 years post-surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place