Trial Outcomes & Findings for Lap-Band Surgery on Adolescents for Safety and Efficacy (NCT NCT00587301)
NCT ID: NCT00587301
Last Updated: 2022-03-22
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
Year 1
Results posted on
2022-03-22
Participant Flow
Participant milestones
| Measure |
Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Overall Study
STARTED
|
119
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Overall Study
Screen Failure
|
9
|
|
Overall Study
Lost to Follow-up
|
22
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Protocol Violation
|
7
|
Baseline Characteristics
Lap-Band Surgery on Adolescents for Safety and Efficacy
Baseline characteristics by cohort
| Measure |
Lap-Band
n=119 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Age, Continuous
|
16.1 years
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
119 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Year 1Outcome measures
| Measure |
Lap-Band
n=106 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Percentage of Excess Weight Loss (EWL)
|
40.88 percentage of EWL
Standard Deviation 25.12
|
PRIMARY outcome
Timeframe: Year 2Outcome measures
| Measure |
Lap-Band
n=95 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Percentage of Excess Weight Loss (EWL)
|
44.18 percentage of EWL
Standard Deviation 26.36
|
PRIMARY outcome
Timeframe: Year 3Outcome measures
| Measure |
Lap-Band
n=87 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Percentage of Excess Weight Loss (EWL)
|
45.19 percentage of EWL
Standard Deviation 25.13
|
PRIMARY outcome
Timeframe: Year 4Outcome measures
| Measure |
Lap-Band
n=81 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Percentage of Excess Weight Loss (EWL)
|
42.96 percentage of EWL
Standard Deviation 26.30
|
PRIMARY outcome
Timeframe: Year 5Outcome measures
| Measure |
Lap-Band
n=74 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Percentage of Excess Weight Loss (EWL)
|
42.6 percentage of EWL
Standard Deviation 26.66
|
SECONDARY outcome
Timeframe: Year 1Outcome measures
| Measure |
Lap-Band
n=106 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Body Mass Index (BMI)
|
37.67 kg/m^2
Standard Deviation 8.93
|
SECONDARY outcome
Timeframe: Year 2Outcome measures
| Measure |
Lap-Band
n=95 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Body Mass Index (BMI)
|
36.54 kg/m^2
Standard Deviation 9.10
|
SECONDARY outcome
Timeframe: Year 3Outcome measures
| Measure |
Lap-Band
n=87 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Body Mass Index (BMI)
|
36 kg/m^2
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Year 4Outcome measures
| Measure |
Lap-Band
n=81 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Body Mass Index (BMI)
|
36.39 kg/m^2
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Year 5Outcome measures
| Measure |
Lap-Band
n=74 Participants
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Body Mass Index (BMI)
|
36.75 kg/m^2
Standard Deviation 8.98
|
Adverse Events
Lap-Band
Serious events: 24 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lap-Band
n=119 participants at risk
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Gastrointestinal disorders
Abdominal pannus (excess skin)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Band erosion
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Band slippage
|
10.1%
12/119 • 5 years
|
|
Gastrointestinal disorders
Cholecystitis
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Cholelithiasis
|
1.7%
2/119 • 5 years
|
|
Gastrointestinal disorders
Cholelithiasis (Aggravated)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Esophageal and gastric pouch dilatation
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Gastric pouch dilatation
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Left tibia surgery for Blount's disease
|
0.84%
1/119 • 5 years
|
|
General disorders
Nausea
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Perforated appendicitis
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Peritonitis
|
0.84%
1/119 • 5 years
|
|
General disorders
Port leak
|
1.7%
2/119 • 5 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with abortion
|
1.7%
2/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Right tibia surgery for Blount's disease
|
0.84%
1/119 • 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.84%
1/119 • 5 years
|
Other adverse events
| Measure |
Lap-Band
n=119 participants at risk
Lap-band surgery in treatment of morbidly obese adolescents
Lap-Band: Obesity and adolescents
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
7/119 • 5 years
|
|
Gastrointestinal disorders
Abdominal subcutaneous infection
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Abnormal EKG (junctional bradycardia)
|
0.84%
1/119 • 5 years
|
|
Endocrine disorders
Acne
|
1.7%
2/119 • 5 years
|
|
General disorders
Acute dysphagia
|
1.7%
2/119 • 5 years
|
|
General disorders
ADD
|
1.7%
2/119 • 5 years
|
|
General disorders
ADHD
|
0.84%
1/119 • 5 years
|
|
Reproductive system and breast disorders
Adnexal mass
|
0.84%
1/119 • 5 years
|
|
General disorders
Adrenal Hyperplasia
|
0.84%
1/119 • 5 years
|
|
General disorders
Anemia
|
1.7%
2/119 • 5 years
|
|
General disorders
Anorexia
|
0.84%
1/119 • 5 years
|
|
Nervous system disorders
Anxiety
|
4.2%
5/119 • 5 years
|
|
Nervous system disorders
Anxiety Attack
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ARD (Acute Respiratory Failure)
|
0.84%
1/119 • 5 years
|
|
General disorders
Back pain
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Band erosion
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Band intolerance
|
1.7%
2/119 • 5 years
|
|
Gastrointestinal disorders
Band intolerance (Chronic dysphagia)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Band slippage
|
7.6%
9/119 • 5 years
|
|
General disorders
Behavioural issue
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bell's palsy
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.84%
1/119 • 5 years
|
|
General disorders
Chest pain
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Cholelithiasis
|
1.7%
2/119 • 5 years
|
|
Gastrointestinal disorders
Chronic band intolerance
|
2.5%
3/119 • 5 years
|
|
Gastrointestinal disorders
Chronic dysphagia with band tightening
|
0.84%
1/119 • 5 years
|
|
General disorders
Common cold
|
5.0%
6/119 • 5 years
|
|
General disorders
Depression
|
0.84%
1/119 • 5 years
|
|
General disorders
Depression (Aggravated)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Device malfunction (Band aneurysm)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Dilated esophagus and gastric pouch
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Dsyphagia
|
0.84%
1/119 • 5 years
|
|
Blood and lymphatic system disorders
Dyslipidemia
|
0.84%
1/119 • 5 years
|
|
Blood and lymphatic system disorders
Dyslipidemia (Aggravated)
|
2.5%
3/119 • 5 years
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
1.7%
2/119 • 5 years
|
|
General disorders
Dysphagia
|
2.5%
3/119 • 5 years
|
|
General disorders
Dysphagia (ER visit)
|
0.84%
1/119 • 5 years
|
|
Ear and labyrinth disorders
Ear and throat infection
|
0.84%
1/119 • 5 years
|
|
Psychiatric disorders
Eating disorder
|
0.84%
1/119 • 5 years
|
|
Blood and lymphatic system disorders
Ecchymosis (post-op site)
|
0.84%
1/119 • 5 years
|
|
Blood and lymphatic system disorders
Elevated bilirubin level
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Elevated TSH
|
0.84%
1/119 • 5 years
|
|
Blood and lymphatic system disorders
Elevated WBC
|
0.84%
1/119 • 5 years
|
|
General disorders
Endometriosis
|
0.84%
1/119 • 5 years
|
|
General disorders
Epigastric pain
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Erosion on antrum (endoscopy)
|
0.84%
1/119 • 5 years
|
|
General disorders
Esophageal dilatation
|
19.3%
23/119 • 5 years
|
|
General disorders
Esophageal irritation
|
0.84%
1/119 • 5 years
|
|
General disorders
Esophageal pain
|
0.84%
1/119 • 5 years
|
|
General disorders
Esophagitis
|
5.0%
6/119 • 5 years
|
|
Skin and subcutaneous tissue disorders
Exacerbation of Eczema
|
0.84%
1/119 • 5 years
|
|
Skin and subcutaneous tissue disorders
Excess skin
|
1.7%
2/119 • 5 years
|
|
Skin and subcutaneous tissue disorders
Excess skin irritation
|
0.84%
1/119 • 5 years
|
|
Skin and subcutaneous tissue disorders
Facial skin infection
|
0.84%
1/119 • 5 years
|
|
General disorders
Fainting
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
0.84%
1/119 • 5 years
|
|
General disorders
Flipped port
|
0.84%
1/119 • 5 years
|
|
Renal and urinary disorders
Frozen pelvis
|
0.84%
1/119 • 5 years
|
|
General disorders
Fungal infection
|
0.84%
1/119 • 5 years
|
|
General disorders
Gallstones
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Gas pain
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Gastric pouch dilatation
|
13.4%
16/119 • 5 years
|
|
Gastrointestinal disorders
Gastric pouch dilation
|
4.2%
5/119 • 5 years
|
|
Gastrointestinal disorders
Gastric pouch formation
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
1.7%
2/119 • 5 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.7%
2/119 • 5 years
|
|
General disorders
GE Reflux
|
1.7%
2/119 • 5 years
|
|
General disorders
GERD
|
1.7%
2/119 • 5 years
|
|
General disorders
Hair Thinning
|
24.4%
29/119 • 5 years
|
|
General disorders
Headaches
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Heartburn
|
14.3%
17/119 • 5 years
|
|
Gastrointestinal disorders
Hiatal hernia
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Hiatal hernia (Esophagram)
|
0.84%
1/119 • 5 years
|
|
General disorders
HTN (Aggravated)
|
0.84%
1/119 • 5 years
|
|
General disorders
Hyperbilirubinemia
|
1.7%
2/119 • 5 years
|
|
General disorders
Hyperbilirubinemia (Aggravated)
|
1.7%
2/119 • 5 years
|
|
Congenital, familial and genetic disorders
Hypercholesterolemia
|
5.9%
7/119 • 5 years
|
|
Congenital, familial and genetic disorders
Hypercholesterolemia (aggravated)
|
1.7%
2/119 • 5 years
|
|
General disorders
Hypertriglyceridemia
|
0.84%
1/119 • 5 years
|
|
General disorders
Hypokalemia
|
0.84%
1/119 • 5 years
|
|
General disorders
Hypothyroidism
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.84%
1/119 • 5 years
|
|
Nervous system disorders
Insomnia
|
0.84%
1/119 • 5 years
|
|
General disorders
Iron deficiency
|
1.7%
2/119 • 5 years
|
|
Gastrointestinal disorders
Kidney stones
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Knee injury (Left)
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.84%
1/119 • 5 years
|
|
Blood and lymphatic system disorders
Low Folate level
|
1.7%
2/119 • 5 years
|
|
Blood and lymphatic system disorders
Low Hb level
|
2.5%
3/119 • 5 years
|
|
General disorders
Low iron level
|
26.1%
31/119 • 5 years
|
|
General disorders
Low iron level (Aggravated)
|
1.7%
2/119 • 5 years
|
|
General disorders
Low Vit. B12 level
|
0.84%
1/119 • 5 years
|
|
General disorders
Low Vit. D level
|
33.6%
40/119 • 5 years
|
|
General disorders
Low Vit. D level (Aggravated)
|
10.1%
12/119 • 5 years
|
|
General disorders
Low Vit. D level (Baseline:24)
|
0.84%
1/119 • 5 years
|
|
Cardiac disorders
Major depression
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Meniscus dislocation (Left)
|
0.84%
1/119 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Meniscus tear
|
0.84%
1/119 • 5 years
|
|
General disorders
Migraine
|
2.5%
3/119 • 5 years
|
|
Immune system disorders
Monocleosis
|
1.7%
2/119 • 5 years
|
|
Immune system disorders
Mononucleosis
|
0.84%
1/119 • 5 years
|
|
Nervous system disorders
Multiple sclerosis
|
0.84%
1/119 • 5 years
|
|
Infections and infestations
Mumps
|
0.84%
1/119 • 5 years
|
|
General disorders
Narcotic addition
|
0.84%
1/119 • 5 years
|
|
General disorders
Nausea
|
0.84%
1/119 • 5 years
|
|
General disorders
Neck pain
|
0.84%
1/119 • 5 years
|
|
Immune system disorders
Numbness after exposing bright light
|
0.84%
1/119 • 5 years
|
|
Nervous system disorders
Panic attack
|
0.84%
1/119 • 5 years
|
|
Nervous system disorders
Panic disorder
|
0.84%
1/119 • 5 years
|
|
General disorders
Port leak
|
0.84%
1/119 • 5 years
|
|
General disorders
Port protrusion
|
0.84%
1/119 • 5 years
|
|
General disorders
Port site pain
|
1.7%
2/119 • 5 years
|
|
General disorders
Post op site infection
|
1.7%
2/119 • 5 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.84%
1/119 • 5 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy with abortion
|
0.84%
1/119 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.84%
1/119 • 5 years
|
|
Immune system disorders
Psoriasis (Aggravated)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Reflux
|
14.3%
17/119 • 5 years
|
|
Immune system disorders
Seasonal allergies
|
0.84%
1/119 • 5 years
|
|
General disorders
Self-inflicted forearm laceration
|
0.84%
1/119 • 5 years
|
|
General disorders
Shoulder pain
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
5.9%
7/119 • 5 years
|
|
Gastrointestinal disorders
Stomach cramps
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Strep throat
|
0.84%
1/119 • 5 years
|
|
Psychiatric disorders
Suicidal threats
|
0.84%
1/119 • 5 years
|
|
General disorders
Testicular torsion
|
0.84%
1/119 • 5 years
|
|
Immune system disorders
Thrombocytopenia
|
1.7%
2/119 • 5 years
|
|
Immune system disorders
Tooth pain
|
0.84%
1/119 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
1.7%
2/119 • 5 years
|
|
Renal and urinary disorders
Urinary tract infection
|
3.4%
4/119 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia (small fat)
|
0.84%
1/119 • 5 years
|
|
Gastrointestinal disorders
Viral gastroenteritis
|
1.7%
2/119 • 5 years
|
|
General disorders
Vit. D Deficiency
|
4.2%
5/119 • 5 years
|
|
General disorders
Wound dehiscence
|
0.84%
1/119 • 5 years
|
|
Infections and infestations
Yeast infection
|
0.84%
1/119 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place