GASTRIC BANDINGBy shally bhardwaj

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

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

GASTRIC BYPASS

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.

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

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.

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.

LAP BAND SYSTEM

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

During SurgeryGastric 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.

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.

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.

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.  

-

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

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.

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.

CLASSIFICATION

Gastric band------Invasive device.Class-IIIRule-2

CLINICAL TRIAL

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

SPONSOR

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

California, Irvine

OFFICIAL TITLE

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

STUDY -DETAILS

Study Type: Interventional

Study Design: Allocation: Randomized

Intervention Model: Parallel Assignment

Masking: Open Label

Primary Purpose: Treatment

STUDY POPULATION

Enrollment:197 Number of Participants Analyzed Gastric bypass-111 Lap band-86

ELIGIBILITY

Ages -Eligible for Study:   18 Years to 60 Years

Genders- Eligible for Study:   Both

Accepts Healthy Volunteers:   No

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

.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.

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

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

INVESTIGATOR

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

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

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

BASE LINE MEASURES 

  Laparoscopic Gastric Bypass

 

  Laparoscopic Adjustable

Gastric Banding (LAP-

BAND)  

  Total  

Number of Participants   [units: participants]

  111     86     197  

Age   [units: participants]      

<=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: participants]      

Female     86     65     151   Male     25     21     46   Region of Enrollment   [units: participants]

     

United States     111     86     197

Baseline Measures

PRIMARY OUTCOME

  Excess Weight Loss From Pre-operation to 5 Years Post-operation

  [ Time Frame: Baseline to 5 years ]

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

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 ForCostPhysicalBodily painGeneral healthVitalitySocial-lifeEmotional and mental life

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

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 patient]Mean ± Standard Deviation

  12310  ± 3099     10767  ± 1631

Measured Values

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.

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

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

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.

REFERENCE

Clinical trials.gov FDA-medical devices-gastric banding