LAGB as a Treatment for Morbid Obesity in Adolescents
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Device: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Excess Weight Change (EWL) [Baseline and up to 5 years from start of study.]
Weight change evaluated in terms of % excess weight loss (EWL).
Secondary Outcome Measures
- Percentage of Excess BMI Change [Baseline and up to 5 years from start of study.]
Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ages 13-17 upon entry
-
BMI >40 or >35 with associated medical comorbidities (e.g., sleep apnea, hypertension
Exclusion Criteria:
-
severe psychiatric illness
-
eating disorder with purging
-
previous weight loss surgery
-
stated inability to comply with pre-op and post-op visits
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Morgan Stanley Children's Hospital of NY Presbyterian | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Jeffrey L Zitsman, MD
Investigators
- Principal Investigator: Jeffrey L Zitsman, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAB1759
Study Results
Participant Flow
| Recruitment Details | Adolescents aged 13 to 18 years were enrolled in this study. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Laparoscopic Gastric Banding |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 137 |
| COMPLETED | 127 |
| NOT COMPLETED | 10 |
Baseline Characteristics
| Arm/Group Title | Adolescents With Morbid Obesity |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 137 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
16.0
(1.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
94
68.6%
|
| Male |
43
31.4%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
23
16.8%
|
| White |
59
43.1%
|
| More than one race |
4
2.9%
|
| Unknown or Not Reported |
51
37.2%
|
| Family obesity (Count of Participants) | |
| Mother |
34
24.8%
|
| Father |
14
10.2%
|
| Both |
31
22.6%
|
| Yes (not identified) |
6
4.4%
|
| Neither |
50
36.5%
|
| Adopted (no information) |
2
1.5%
|
Outcome Measures
| Title | Percentage of Excess Weight Change (EWL) |
|---|---|
| Description | Weight change evaluated in terms of % excess weight loss (EWL). |
| Time Frame | Baseline and up to 5 years from start of study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes individuals with confirmed band status at 5 years after surgery. |
| Arm/Group Title | Laparoscopic Gastric Banding |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 127 |
| Mean (Standard Deviation) [percent change] |
-35.5
(39.4)
|
| Title | Percentage of Excess BMI Change |
|---|---|
| Description | Change in Body mass index (BMI) in terms of excess BMI loss (EBMIL). |
| Time Frame | Baseline and up to 5 years from start of study. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes individuals with confirmed band status at 5 years after surgery. |
| Arm/Group Title | Laparoscopic Gastric Banding |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 127 |
| Mean (Standard Deviation) [percent change] |
36.6
(37.5)
|
Adverse Events
| Time Frame | 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. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Laparoscopic Gastric Banding | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Laparoscopic Gastric Banding | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/137 (2.2%) | |
Serious Adverse Events |
||
| Laparoscopic Gastric Banding | ||
| Affected / at Risk (%) | # Events | |
| Total | 63/137 (46%) | |
| Surgical and medical procedures | ||
| Band removal due to dysphagia, reflux or heartburn | 3/137 (2.2%) | 3 |
| Hiatal hernia repair | 1/137 (0.7%) | 1 |
| Gastric Herniation (band slippage) | 10/137 (7.3%) | 10 |
| Port site bleeding | 1/137 (0.7%) | 1 |
| Malpositioned band | 1/137 (0.7%) | 1 |
| Intestinal obstruction | 1/137 (0.7%) | 1 |
| Port displacement | 11/137 (8%) | 11 |
| Band removal | 33/137 (24.1%) | 33 |
| Weight loss procedure (conversion) | 16/137 (11.7%) | 16 |
Other (Not Including Serious) Adverse Events |
||
| Laparoscopic Gastric Banding | ||
| Affected / at Risk (%) | # Events | |
| Total | 137/137 (100%) | |
| Gastrointestinal disorders | ||
| Emesis | 96/137 (70.1%) | 266 |
| Abdominal pain | 62/137 (45.3%) | 114 |
| GERD/Heartburn | 44/137 (32.1%) | 68 |
| Diarrhea | 18/137 (13.1%) | 25 |
| General disorders | ||
| Port site pain | 46/137 (33.6%) | 73 |
| Headaches | 14/137 (10.2%) | 16 |
| Sore throat | 14/137 (10.2%) | 15 |
| Back pain | 12/137 (8.8%) | 12 |
| Elevated CES-D Score | 12/137 (8.8%) | 12 |
| Dehydration | 8/137 (5.8%) | 8 |
| Knee pain | 8/137 (5.8%) | 11 |
| Esophageal dilation | 7/137 (5.1%) | 9 |
| Infections and infestations | ||
| Upper respiratory infection (URI) | 32/137 (23.4%) | 40 |
| Sinusitis | 7/137 (5.1%) | 8 |
| Fever | 7/137 (5.1%) | 7 |
| Metabolism and nutrition disorders | ||
| Dysphagia/food stuck | 40/137 (29.2%) | 76 |
| Esophagitis | 8/137 (5.8%) | 9 |
| Surgical and medical procedures | ||
| Band slip/prolapse | 10/137 (7.3%) | 14 |
| Port displacement/flip | 9/137 (6.6%) | 10 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jeffrey Zitsman, MD |
|---|---|
| Organization | Columbia University |
| Phone | 212-305-8862 |
| jlz2@cumc.columbia.edu |
- AAAB1759