Clinical Investigation of the LAP-BAND medical device
1. Topic by: Jayann Brown
Affiliation: Clinical Research Program
Humber College Institute of Technology and
Advanced Learning
March 2014
2. Title: Laparoscopic Gastric Bypass vs. LAP
BAND for treatment of morbid obesity
Clinical Trials.gov identifier: NCT00247377
Trial was completed (App. 6 yrs)
Principal Investigator: Ninh T Nguyen MD
Sponsor Organization: University of California
Clinical trial was conducted at University of
California Irvine Medical Center
3. LAP-BAND can be performed safely and is
associated with reduced postoperative pain,
decrease in morbidity, decreased ICU and hospital
stay, reduced costs, comparable improvement in
quality-of-life, and acceptable long-term weight
loss compared with laparoscopic GBP
LAP-BAND is associated with a decrease in fluid
requirement in the peri-operative period, improved
postoperative pulmonary function, and lower intra-
abdominal pressure compared to laparoscopic
GBP
LAP-BAND does not alter esophageal motility and
is effective in improvement of gastro-esophageal
reflux disease (GERD) symptoms.
4. Severe obesity or morbid obesity (being 100lbs
above ideal body weight) is a growing problem
in the U.S.
Individuals engaged in exercise ,dietary
restriction, behaviour modification,
pharmacological intervention regained weight
in 2-4 yrs
Surgery is the only effective sustained weight
loss treatment ( NIH conference 1991)
5. Roux-en-Y gastric Bypass (GBP) is the golden
standard bariatric surgical operation
Mean weight loss following GBP = App. 65%
of the excess body weight during the first 12 -
18 mths
Long-term weight loss= App. 55-70% of
excess body weight
Open & Laparoscopic GBP is associated with
significant mortality and morbidity,
anastomotic leak, pulmonary embolism, bowel
obstruction, and postoperative stricture.
6. In 2001 FDA approved the Laparoscopic
Adjustable banding system (LAP-BAND) for
weight reduction in morbid obese individuals
No cutting or opening of the stomach wall
Purpose of the study: to evaluate if the LAP-
BAND procedure is as effective as the
laparoscopic GBP procedure for treatment of
morbid obesity.
7. The LAP-BAND®
consists of a silicone
gastric band which
encircles the stoma.
The inner surface of the
silicone band is
inflatable and is
connected by the tubing
to the access port.
Class III medical device
Premarket approval #:
P000008/S017
8. 5 holes drilled in stomach , camera guides the
placement of the band around the upper part
of the stomach.
The band creates a small stomach pouch that
can hold only a small amount of food.
The surgeon adjusts the band by (adding or
removing fluid, usually saline) by using a
needle to pierce the access port, which is placed
just beneath the skin.
10. To determine the short-term outcome, quality-of-
life, costs, and long-term weight loss after
laparoscopic GBP compared with LAP-BAND.
To compare physiologic changes such as peri-
operative fluid requirement, postoperative
pulmonary function, and intra-abdominal pressure
after laparoscopic GBP and LAP-BAND.
To evaluate the effect of LAP-BAND on
esophageal motility and its effectiveness in
controlling gastro-esophageal reflux symptoms
(GERD) for morbidly obese patients.
11. There will be two arms each projected to have
100 subjects for clinical significance of 0.05%.
Arm1. Active comparator- LAP BAND
Arm2. Active comparator –Laparoscopic GBP
Dropout rate is expected to be app. 20% (N=
n/1-d)
The total number of subjects estimated to be
enrolled in the program is 250.
14. Body mass index (BMI) 40 kg/m2 or BMI 35
kg/m2 with significant obesity-related co-
morbidities ( Normal BMI = 20-25kg/m2)
Acceptable operative risk
Documented failure of nonsurgical weight-loss
programs
Psychologically stable with realistic expectations
Well-informed and motivated patient
Supportive family/social environment
Absence of uncontrolled psychotic or depressive
disorder
No active alcohol or substance abuse
15. Male or female patients with a BMI of 40-60
kg/m2 or 35kg/m2 with co-morbidities
Good health status with acceptable operative
risk ( good cardiopulmonary function)
A willingness to follow protocol requirements:
i.e. signing informed consent forms, follow –up
and completing protocol diagnostic tests.
16. Prior upper abdominal surgery except
cholecystectomy
Large abdominal ventral hernia
Hiatal hernia
Inadequate prior medical management
Lack of patient motivation and contribution to
long term success (Patient must be willing to make
major changes in their eating habits and lifestyle)
Unacceptable operative risk
Minors are not psychologically fit to undergo such
surgery and pregnant women are excluded
because of safety for the fetus
17. The pre-operative screening will consist of:
Physical exam
Psychological exam,
Complete blood tests,
Imaging studies,
Gastroscopy,
Consultations with various specialists :
surgeon, endocrinologist, clinical nutritionist.
See Study Table
20. PRIMARY OUTCOME MEASURE
Excess Weight Loss From Pre-operation to 5 Years Post-
operation (weight loss as measured by change in percent of
excess body weight)
[Time Frame: Baseline to 5
years [ Designated as safety issue: No ]
SECONDARY OUTCOME MEASURES
Changes in Quality of Life: Physical Functioning. Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation
(Response where 0 is non-functioning and 100 is fully
functioning)
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
Cost of Procedure to the Medical Facility on Date of Procedure
(operative and post-operative direct costs including hospital
service costs per patient. costs reflect the average cost per
patient in each of the two groups (band vs. bypass) at a single
time point)
[ Time Frame: date of surgery ]
[ Designated as safety issue: No ]
21. Changes in Quality of Life: Physical Role- Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation. (
0 corresponds to no Physical Role and 100 corresponds to
full Physical Role )
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
Changes in Quality of Life: Bodily Pain Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation. (0
corresponds to no bodily pain and 100 corresponds to
complete bodily pain )
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
22. Changes in Quality of Life: General Health. Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation (0
corresponds to no general health satisfaction and 100 corresponds
to complete health satisfaction )
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
Changes in Quality of Life: Vitality. Using SF-36 Questionnaire
Pre-operation to 12 Months Post-operation ( worst score being 0
and best score being 100 on a 1-100 point scale.)
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
Changes in Quality of Life: Social Functioning. Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation
(Response where 0 corresponds to no social functioning and 100
corresponds to full social functioning )
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
23. Changes in Quality of Life : Emotional Role. Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation ( 0
corresponds to no emotional role and 100 corresponds to full
emotional role)
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
Changes in Quality of Life: Mental Health. Using SF-36
Questionnaire From Pre-operation to 12 Months Post-operation (0
corresponds to no mental health well-being and 100 corresponds
to complete mental health well-being)
[ Time Frame: Baseline to 12 months ]
[ Designated as safety issue: No ]
24. Common side effects include nausea and
vomiting, heartburn, abdominal pain, and
slippage of the band
Serious Adverse Events include: erosion of the
stomach, mortality (1/2000)
The most serious side effects require either
another operation or hospitalization.
Surgery is reversible and LAP BAND can be
removed
25. Check-ups with the doctor is very important
part of Lap Band follow-up.
If necessary adjustments are done.
Depending on individual case checks will be
First month- Weekly or biweekly
First year: 4-12 weeks
Second and third year:3-6 mths
Up to 5 yrs: annually
26. Will be determined by the severity and will be determined
as :
Mild - symptom barely noticeable to the patient; does not affect
performance or functioning. Prescription drugs not ordinarily
needed for relief of symptom.
Moderate - symptom of sufficient severity to make patient
uncomfortable; performance of daily activities affected; patient is
unable to continue in study. Treatment of symptoms is needed.
Severe - symptom causes severe discomfort and may be such that
patient cannot perform daily activities. Severity may result in
cessation of treatment or require removal of the device, or
treatment of symptom may be given and/or patient hospitalized.
27. Determined to be clinically effective if:
40% of the patients achieve weight loss of 30% of
excess weight after 1yr
Co-morbid conditions e.g.. type II diabetes,
hypertension measures are reduced
Quality of life by the impact of weight loss is
improved based on SF-36
28. P000008/S017: FDA Summary of Safety and Effectiveness .Retrieved 3/26/2014
from website http://www.accessdata.fda.gov/cdrh_docs/pdf/P000008S017b.pdf
Schematic of study Design . Retrieved3/22/ 2014 from website
www.nidcr.nih.gov/NR/.../0/Schematic_of_Study_Design_Form.doc
Laparoscopic gastric banding Retrieved 3/22/2014 from website
http://www.nlm.nih.gov/medlineplus/ency/article/007388.htm
LAP-BAND® Adjustable Gastric Banding System - P000008/S017. Retrieved
3/22/2014
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapp
rovalsandclearances/recently-approveddevices/ucm248133.htm
Laparoscopic gastric bypass vs. LAP-BAND for Treatment of Morbid Obesity.
Retrieved from 3/7/2014 from
http://clinicaltrials.gov/ct2/show/NCT00247377?term=laparoscopic+lapband&ra
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