Morbid Obesity
Conditions
Keywords
Lap-Band, morbid obesity, adolescents
Brief summary
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
Detailed description
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents
Interventions
DEVICEAdjustable Gastric Band
Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Sponsors
Kirk Reichard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* ages 14-19 * BMI \> 35 * history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months. * confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.
Exclusion criteria
* history of congenital or acquired anomalies of the GI tract. * history of esophageal motility disorders * uncontrolled psychiatric problems * previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis. * uncontrolled eating disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Weight Loss | Up to five years post surgery. | Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Resistance | Baseline | Fasting insulin level |
Countries
United States
Participant flow
Recruitment details
Eligible patients were recruited from the pediatric weight management clinic.
Pre-assignment details
Of 136 eligible patients, 57 completed the pre-intervention program and underwent placement of the gastric band. The remainder opted out of the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Gastric Band Lap Band Surgery was ultimately performed on 57 patients, the remainder chose alternative management. | 57 |
| Total | 57 |
Baseline characteristics
| Characteristic | Gastric Band |
|---|---|
| Age, Categorical <=18 years | 56 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 16.05 years STANDARD_DEVIATION 1.22 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 9 Participants |
| Weight | 139.36 Kilogram STANDARD_DEVIATION 19.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 2 / 57 |
Outcome results
Primary
Total Weight Loss
Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial
Time frame: Up to five years post surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Loss | Total Weight Loss | 11.35 kilograms | Standard Deviation 19.08 |
Secondary
Insulin Resistance
Fasting insulin level
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weight Loss | Insulin Resistance | 12.5 uIU/ml | Standard Deviation 14 |