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Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.
Seventy to ninety-eight percent of obese children become obese adults. Comorbidities of obesity such as type II diabetes, fatty liver disease, hyperlipidemia, hypertension, asthma, sleep apnea, and depression are becoming increasing common in adolescents as more adolescents become obese. The only consistently durable and effective weight loss programs for the morbidly obese patients are those that include bariatric surgical procedures. The investigators believe that the best initial bariatric surgical option for adolescents is LAGB because of its low complication rates, adjustability, and reversibility. Obese adolescents ages 14-17 who meet criteria for entry will be enrolled to determine the degree of success of LAGB as measured by % excess weight loss, decreased % body fat, decreased body mass index (BMI), reduction in comorbid conditions, and metabolic parameters (including serum lipids and glucose tolerance) at intervals of 3 months, 6 months, 1 year, then annually for a total of 5 years postoperatively. Eligible patients will have been followed for 6 months by physicians in the Center for Adolescent Bariatric Surgery and: 1) will attended a minimum of 75% of visits and 2) will have failed to lose at least 20% of excess weight. Following evaluation by the team (which will include evaluations by a nutritionist, an endocrinologist, a psychologist/psychiatrist, a pediatric nurse practitioner, and a surgeon) a patient may be offered LAGB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic gastric banding | Experimental | Adolescent patients who have undergone laparoscopic adjustable gastric banding. Weight, BMI, and co-morbidity data will be compared to patient's pre-operative values. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic adjustable gastric banding (Allergan Lap Band) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Excess Weight Change (EWL) | Weight change evaluated in terms of % excess weight loss (EWL). | Baseline and up to 5 years from start of study. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Excess BMI Change | Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL). | Baseline and up to 5 years from start of study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Zitsman, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morgan Stanley Children's Hospital of NY Presbyterian | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23140654 | Derived | Sysko R, Devlin MJ, Hildebrandt TB, Brewer SK, Zitsman JL, Walsh BT. Psychological outcomes and predictors of initial weight loss outcomes among severely obese adolescents receiving laparoscopic adjustable gastric banding. J Clin Psychiatry. 2012 Oct;73(10):1351-7. doi: 10.4088/JCP.12m07690. | |
| 21299450 | Derived |
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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.
Adolescents aged 13 to 18 years were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
adolescents with morbid obesity 14-18yr
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescents With Morbid Obesity | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Excess Weight Change (EWL) | Weight change evaluated in terms of % excess weight loss (EWL). | Includes individuals with confirmed band status at 5 years after surgery. | Posted | Mean | Standard Deviation | percent change | Baseline and up to 5 years from start of study. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Band removal due to dysphagia, reflux or heartburn | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Zitsman, MD | Columbia University | 212-305-8862 | jlz2@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D020181 | Sleep Apnea, Obstructive |
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
|
| Sysko R, Zakarin EB, Devlin MJ, Bush J, Walsh BT. A latent class analysis of psychiatric symptoms among 125 adolescents in a bariatric surgery program. Int J Pediatr Obes. 2011 Aug;6(3-4):289-97. doi: 10.3109/17477166.2010.545411. Epub 2011 Feb 8. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Family obesity | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Excess BMI Change | Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL). | Includes individuals with confirmed band status at 5 years after surgery. | Posted | Mean | Standard Deviation | percent change | Baseline and up to 5 years from start of study. |
|
|
|
| 3 |
| 137 |
| 63 |
| 137 |
| 137 |
| 137 |
| Hiatal hernia repair | Surgical and medical procedures | Non-systematic Assessment |
|
| Gastric Herniation (band slippage) | Surgical and medical procedures | Non-systematic Assessment |
|
| Port site bleeding | Surgical and medical procedures | Non-systematic Assessment | Resulted in surgery |
|
| Malpositioned band | Surgical and medical procedures | Non-systematic Assessment | Resulted in surgery |
|
| Intestinal obstruction | Surgical and medical procedures | Non-systematic Assessment | Resulted in surgery. |
|
| Port displacement | Surgical and medical procedures | Non-systematic Assessment | Resulted in operative port repositioning. |
|
| Band removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Weight loss procedure (conversion) | Surgical and medical procedures | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Port site pain | General disorders | Non-systematic Assessment |
|
| GERD/Heartburn | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysphagia/food stuck | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Upper respiratory infection (URI) | Infections and infestations | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headaches | General disorders | Non-systematic Assessment |
|
| Sore throat | General disorders | Non-systematic Assessment |
|
| Back pain | General disorders | Non-systematic Assessment |
|
| Elevated CES-D Score | General disorders | Non-systematic Assessment |
|
| Band slip/prolapse | Surgical and medical procedures | Non-systematic Assessment |
|
| Port displacement/flip | Surgical and medical procedures | Non-systematic Assessment |
|
| Dehydration | General disorders | Non-systematic Assessment |
|
| Knee pain | General disorders | Non-systematic Assessment |
|
| Esophagitis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Esophageal dilation | General disorders | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Fever | Infections and infestations | Non-systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |