Gastric-Banding as a Medical device for Morbid obesity.

1. GASTRIC BANDING
By shally bhardwaj

2. OBESITY
 Obesity is a major public health concern and has been
linked to many health problems such as heart
disease, stroke, diabetes, high blood pressure, sleep
disorders, and breathing problems.
 Obesity (an excessive amount of body fat) is defined
by body mass index (BMI), which is calculated from a
person’s weight and height. A BMI of 30 or more is
considered obese.
 Morbid obesity is an excess of body fat, or weight of
100 pounds over ideal body weight, that increases the
risk of developing cardiac and endocrine disturbances,
including coronary artery disease and diabetes
mellitus, as well as some kinds of cancer

3. HOW TO TREAT OBESITY
 Treatments for obesity range from
 Healthy eating
 Exercise
 Prescription medicine
 Surgery-gastric bypass
 FDA-regulated medical devices have also played
a role in treating obesity- gastric band

4. GASTRIC BYPASS

5. GASTRIC BYPASS
 Gastric bypass procedures (GBP) are any of a
group of similar operations that first divides the
stomach into a small upper pouch and a much
larger lower "remnant" pouch and then re-
arranges the small intestine to connect to both.
Surgeons have developed several different ways
to reconnect the intestine, thus leading to several
different GBP names. Any GBP leads to a
marked reduction in the functional volume of the
stomach, accompanied by an altered physiological
and physical response to food.

6. GASTRIC BYPASS-PROCEDURE
 The gastric bypass procedure consists of:
 Creation of a small, (15–30 mL/1–2 tbsp) thumb-sized pouch from the
upper stomach, accompanied by bypass of the remaining stomach
(about 400 mL and variable). This restricts the volume of food which
can be eaten. The stomach may simply be partitioned (like a wall
between two rooms in a house or two office cubicles next to each other
with a partition wall in between them - and typically by the use of
surgical staples), or it may be totally divided into two
separate/separated parts (also with staples). Total division
(separate/separated parts) is usually advocated to reduce the
possibility that the two parts of the stomach will heal back together
("fistulize") and negate the operation.
 Re-construction of the GI tract to enable drainage of both segments of
the stomach. The particular technique used for this reconstruction
produces several variants of the operation, differing in the lengths of
small intestine used, the degree to which food absorption is affected,
and the likelihood of adverse nutritional effects. Usually, a segment of
the small bowel (called the alimentary limb) is brought up to the
proximal remains of the stomach

7. THE TYPES OF OBESITY TREATMENT
DEVICES
 Currently, there are two FDA-approved devices
on the market designed to treat obesity:
 Lap-Band Gastric Banding System and
 Realize Gastric Band.

8. WHAT IS LAP BAND SYSTEM
The Lap-Band System is a surgically implanted
device that helps adults who are at least 18 years
old eat less and lose weight. The Lap-Band consists
of a silicone band, tubing, and an access port. The
inner surface of the silicone band is inflatable and
is connected by the tubing to the access port. The
band limits the amount of food that can be eaten at
one time and increases the time it takes for food to
be digested, helping people to eat less.

9. LAP BAND SYSTEM

10. THE REALIZE BAND
 The Realize Band is a surgically implanted
device used to help adults (18 years of age or
older) lose weight. The Realize Band consists of a
silicone band, tubing, and an injection port. The
band helps a person eat less by limiting the
amount of food that can be eaten at one time and
increasing the time it takes for food to be
digested

12. During Surgery
Gastric banding is usually performed
using laparoscopic surgery. The surgery
is performed while the patient is asleep
(general anesthesia). The surgeon makes
one to five small cuts (incisions) in the
abdomen. A small camera and surgical
instruments are placed through the cuts
into the abdominal cavity.
During the surgery, the surgeon places
an adjustable silicone band around the
upper part of the stomach to create a
small pouch. The band is connected with
tubing to a port near the skin. Once the
device is in place, the camera and
surgical instruments are removed and
the cuts are closed with stitches.
The surgery usually takes about an hour
to complete. Patients are usually sent
home the same day as the procedure and
are able to return to their normal
activities, including returning to work, a
few days later.

13. After Surgery
Following surgery, the doctor can adjust
the band, without the need for additional
surgery, by adding or removing fluid
through the implanted port. These
adjustments tighten or loosen the band,
allowing less or more or food to fit in the
stomach.

14. BENEFITS OF GASTRIC BANDING
 Gastric banding has demonstrated benefits for people who have not been
successful using non-surgical weight loss methods. This surgical procedure may
help patients lose weight and maintain the weight loss, and it may help
improve their health.
 Some patients who have received gastric banding have reported the following
benefits:
 Weight-loss
 Decreased waist and hip circumference
 Improvements in obesity-related conditions, like diabetes, hypertension, and
sleep apnea
 Improvements in general health
 Improvements in quality of life
 Another benefit of gastric banding is that it can be performed in a minimally
invasive manner using laparoscopic surgery. Compared to other surgeries used
to treat obesity, laparoscopic gastric banding is less painful, uses smaller
incisions, usually has a shorter surgery recovery time, and allows patients to go
home from the hospital sooner after surgery.
 Patients who are committed to making major, lifelong changes to their eating
habits are likely to have better weight-loss outcomes with gastric banding than
those who do not.

15. LIFESTYLE CHANGES AFTER GASTRIC
BANDING SURGERY
 Gastric banding is not a “quick fix.”
 In order to be successful in losing weight with gastric banding, you must make
major, long-term changes to your eating habits. The smaller pouch that is
created at the top of your stomach will only be able to hold about a quarter cup
of food at a time. If you eat too much, you may have complications such as
nausea and vomiting.
 For the first month or two after surgery you will be able to eat very little and
will have to slowly add foods to your diet. Your surgeon and/or dietician will
work with you to:
 make smart food choices
 teach you about changing how you chew and swallow your food
 advise you on what foods to avoid
 help you recognize when you are full
 increase your physical activity
 In addition to making changes to your diet, you will need to make regular
follow-up visits to your doctor to monitor your progress and make any
adjustments to your band.
 -

16. PATIENT ELIGIBILITY
Gastric banding devices are approved for patients
with the following characteristics:
1. 18 years and older AND
2. BMI of 40 or higher OR
3. Between 30 and 40 with one or more obesity-
related medical conditions, such as high blood
pressure, heart disease, diabetes or sleep apnea

17. CONTRA- INDICATED
 The FDA has not approved any gastric band for
use in patients under 18 because the agency has
not reviewed the safety and effectiveness of
gastric bands in patients of this age.
 1. People with certain stomach or intestinal
disorders.
 2. Those who take aspirin frequently.
 3. Those who regularly use alcohol and certain
drugs should not have gastric banding.

18. RISKS OF GASTRIC BANDING
In addition to the risks of surgery, you could experience any of the
following complications after gastric banding surgery:
 nausea
 vomiting or spitting-up food you just ate
 difficulty swallowing
 gastroesophageal reflux disease (GERD)4
 indigestion or upset stomach
 abdominal pain
 leaking of the gastric band
 stretching of the new stomach pouch, so it no longer restricts the amount
of food you can eat
 moving of the gastric band from its original position, requiring another
surgery to reposition it
 erosion of the band through the stomach wall, and into the stomach,
requiring additional surgery
 stretching of the esophagus.
 If one experience any of these complications, one should talk to doctor
right away.
 Some complications may lead to more operations or removal of the device.

19. CLASSIFICATION
Gastric band------Invasive device.
Class-III
Rule-2

20. CLINICAL TRIAL
Laparoscopic Gastric Bypass vs LAP-BAND
for Treatment of Morbid Obesity
ClinicalTrials.gov Identifier:NCT00247377
 First received: October 31, 2005
 Last updated: May 11, 2010
 Last verified: May 2010

21. SPONSOR
 This study has been completed.
 Sponsor: University of California, Irvine
 Information provided by: University of
California, Irvine

22. OFFICIAL TITLE
 A Prospective Randomized Trial of Laparoscopic
Gastric Bypass vs Laparoscopic Adjustable
Gastric Banding (LAP-BAND) for Treatment of
Morbid Obesity

23. STUDY -DETAILS
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assig
nment
Masking: Open Label
Primary Purpose: Treatment

24. STUDY POPULATION
 Enrollment:197
 Number of Participants Analyzed
 Gastric bypass-111
 Lap band-86

25. ELIGIBILITY
Ages -Eligible for Study:
18 Years to 60 Years
Genders- Eligible for Study:
Both
Accepts Healthy Volunteers: No

26. INCLUSION CRITERIA
 Male or female patients with BMI of 40-60 kg/m2
or 35 kg/m2 with comorbidities
 Good health status with acceptable operative risk
(good cardiopulmonary function)
 Willingness to follow protocol requirements:
Signing informed consent, follow-up, and
completing protocol diagnostic tests

27. .EXCLUSION CRITERIA
 Prior upper abdominal surgery except
cholecystectomy
 Large abdominal ventral hernia
 Patients with hiatal hernia
 Inadequate prior medical management
 Lack of patient's motivation and contribution to long-
term success
 Unacceptable operative risk
 Minors and pregnant women are excluded as these
patients do not qualify for the bariatric procedures.
Minors are not psychologically fit to undergo such
surgery and pregnant women are excluded because of
safety for the fetus.

28. OBJECTIVES AND SPECIFIC AIMS:
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
perioperative 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 with GERD

29. HYPOTHESIS
 LAP-BAND can be performed safely and are
associated with reduced postoperative pain, decrease
in morbidity, decrease 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 perioperative 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

30. INVESTIGATOR
Principal Investigator:
Ninh T Nguyen,
MD University of California, Irvine Medical
Center, Orange, CA
Organization: UCI
phone: 714-456-8598
e-mail: ninhn@uci.edu

31. STUDY ARMS
 Active Comparator: Laparoscopic Gastric Bypass
Subject undergoes Laparoscopic Gastric Bypass
 Intervention: Procedure: Gastric bypass surgery
 Active Comparator: LAP-BAND Subject
undergoes LAP-BAND procedure
 Intervention: Procedure: Lap-Band

32. OUT COME MEASURING
 Demographic data
 Operative time
 Blood loss
 Length of hospital stay
 Morbidity
 Mortality
 Early and late reoperation rate
 Weight-loss
 Changes in quality of life and cost

33. BASE LINE MEASURES
Laparoscopic
Gastric Bypass
Laparoscopic
Adjustable
Gastric Banding
(LAP-BAND)
Total
Number of
Participants
[units: participa
nts]
111 86 197
Age
[units: participa
nts]
<=18 years 0 0 0
Between 18 and
65 years
111 86 197
>=65 years 0 0 0
Age
[units: years]
Mean
± Standard
Deviation
41.4 ± 11.0 45.8 ± 9.8 43.6 ± 10.4
Gender
[units: participa
nts]
Female 86 65 151
Male 25 21 46
Region of
Enrollment
[units: participa
nts]
United States 111 86 197
Baseline Measures

34. PRIMARY OUTCOME
 Excess Weight Loss From Pre-operation to 5
Years Post-operation
 [ Time Frame: Baseline to 5 years ]

35. PRIMARY OUTCOME-MEASURED VALUES
Laparoscopic Gastric
Bypass
Laparoscopic
Adjustable Gastric
Banding (LAP-BAND)
Number of
Participants Analyzed
[units: participants]
111 86
Excess Weight Loss
From Pre-operation to
5 Years Post-
operation
[units: percent change]
Mean ± Standard
Deviation
68.4 ± 19.5 45.4 ± 27.
Measured Values

36. SECONDARY OUT -COME
Changes in Quality of Life-
Physical Functioning Using SF-36 Questionnaire
Pre-operation to 12 Months Post-operation [ Time
Frame: Baseline to 12 months
For
Cost
Physical
Bodily pain
General health
Vitality
Social-life
Emotional and mental life

37. SECONDARY OUTCOME-MEASURED
Laparoscopic Gastric
Bypass
Laparoscopic
Adjustable Gastric
Banding (LAP-BAND)
Number of
Participants Analyzed
[units: participants]
111 86
Changes in Quality of
Life- Physical
Functioning Using SF-
36 Questionnaire Pre-
operation to 12 Months
Post-operation
[units: units on a scale]
Mean ± Standard
Deviation
86.8 ± 14.2 93.1 ± 8.8

38. SECONDARY: COST OF PROCEDURE TO THE
MEDICAL FACILITY ON DATE OF PROCEDURE [
(TIME FRAME: DATE OF SURGERY)
Laparoscopic Gastric
Bypass
Laparoscopic
Adjustable Gastric
Banding (LAP-BAND)
Number of
Participants Analyzed
[units: participants]
111 86
Cost of Procedure to
the Medical Facility on
Date of Procedure
[units: dollars per patie
nt]
Mean ± Standard
Deviation
12310 ± 3099 10767 ± 1631
Measured Values

39. RESULTS
 There was no death at 90 day in either groups.
 The mean BMI was higher in gastric by pass
group.(47.5 vs 45.5 kg/m2 respectively p<0.01
 While the mean age was higher in gastric band
group(45 vs 41 years) p<0.01
 Compared with gastric banding operative blood
lass was higher after gastric bypass and the
mean operative time and length of stay was
longer in gastric bypass group.
 The 30 day complication rate was higher after
gastric bypass 21.6% v/s 7.0% for gastric band.

40. RESULTS(SAFTY AND EFFICACY DATA)
 The 1 year mortality was 0.9% for gastric bypass
group and 0.1% for gastric band
 The % of excess weight loss at 4 years was
higher in gastric bypass group (68+/-19% vs 45+/-
28%) p<0.05
 Treatment failure occurred in 16.7% of the
patients who underwent gastric banding and in
0% of who underwent gastric bypass with male
gender being a predictive factor for poor weight
loss after gastric banding

41. RESULTS……….CONTINUED
 At 1 year post surgery quality of life improves in
both groups to that of US norms.
 The total cost was higher for gastric bypass as
compared with gastric banding procedure
($12310 Vs $10766) p<0.01

42. CONCLUSION
 laparoscopic gastric bypass and gastric banding
are both safe and effective approaches for the
treatment of morbid obesity
 Gastric bypass resulted in better weight loss and
medium and long term follow up but was
associated with more peri –operative and late
complications and higher 30 day re admission
rate.
 There was a wide variation in weight loss after
gastric banding with a small proportion of
patients considered as treatment failure and
male gender was a predictive factor for poor
weight loss.

43. REFERENCE
 Clinical trials.gov
 FDA-medical devices-gastric banding