Infertility is a common problem in morbidly obese patients due to the fat cells destroying the female hormone, estrogen. Infertility can also be an indication for weight loss surgery in couples who wish to have children. However, patients who have had a gastric bypass for weight loss should not become pregnant for at least 18 months after surgery due to the risk of damage to the unborn baby from inadequate nutrition. The loop of intestine used to bypass the distal stomach (ROUX limb) does not absorb nutrients the first 12-14 months. By 18 months the bowel thickens and undergoes changes which allow it to begin re-absorbing nutrients which can be vital to a growing fetus.

While morbidly obese women have an increased risk of infertility, miscarriages and birth defects, this risk reverts to normal with significant weight loss. A large study from California followed over 150 women who became pregnant after gastric bypass and there was no increased incidence of problems as long as they waited 18 months after surgery.

Vitamins and especially FOLATE are critical to the formation of nerve tissue such as the brain in a fetus, therefore it is important any women considering pregnancy should be diligent about taking their vitamins and have their folate, iron and B-12 level checked before they become pregnant.

All post-op female patients should utilize birth control for the 18 month period even if they have experienced infertility and been told “you can’t have children”. Several of our patients have become pregnant prior to the 18 month safe period and our policy is to inform them they are at extremely high risk of having a child with significant birth defects and we urge them to consider a therapeutic abortion out of medical necessity.

Pregnancy is possible at an earlier time if patients undergo a VBG or Lap-band, but adequate vitamin levels and supplements are equally important. The pregnancy will interrupt the weight loss process and therefore it is best to wait at least one year after these two procedures.

J K CHAMPION MD

POST-OP NUTRITIONAL SUPPLEMENTS AND MONITORING

Problems with nutrition or malnutrition can develop after surgery for morbid obesity. The absorption or intake of vitamins, minerals, and nutrients may be reduced enough to adversely effect your health. These problems can usually be corrected with supplements if detected early. This is why we emphasize periodic nutritional monitoring with blood tests for life, so deficiencies can be addressed. Occasionally (1/200) nutritional problems fail to respond to supplements and a reversal of weight loss surgery is indicated, although there is increased operative risk with subsequent surgery.

The purpose of this newsletter is to emphasize the importance of taking vitamin and calcium supplements after surgery and having routinely yearly blood monitoring by our office to try and avoid complications. We are seeing a lot of patients not taking supplements and refusing to keep follow-up appointments, or be monitored by their local physician, despite everyone signing a contract to comply. Permanent irreversible damage to your health, or even death can result from failure to follow post-op instructions.

Lets review our recommendations for nutritional supplements and monitoring:

Vitamins:

Vitamins are organic chemicals needed in small amounts to assist in normal metabolism that cannot be manufactured in the body. They must come from outside. They assist our body to function normally and severe irreversible damage can occur from deficiencies

Examples

B vitamins;  thiamine B1, riboflavin B2, niacin B3, pyridoxine B6, cobalamin B12

These are needed for metabolism and effect cardiovascular and nervous system function. Deficiences can cause permanent nerve damage, which is irreversible, anemia, cardiovascular disease and heart failure, and birth defects in pregnant women.

Folic acid; needed to form genes and promote growth

Vitamin C; antioxidant

Vitamin A; important in vision and skin, also antioxidant

Vitamin D; needed for calcium absorption

Vitamin E; antioxidant and important for fertility and muscle function

Minerals:

Minerals are non-organic chemicals we need to function normally

Examples:

Iron; required to form red blood cells which transport oxygen in our body

Calcium; for bone formation and chemical messenger in heart and nerve tissue. Deficiencies cause osteoporosis

Phosphorus; important for cell activity as energy source

Magnesium; required to assist other proteins to work

These vitamins and minerals can be obtained in a good multivitamin with iron such as the Flintstones chewable we provided in the office. Other examples of good vitamins include one-a-day, Centrum, Theragram. All should include additional iron. Calcium supplements are required with 1000 mg per day. Examples are 3 Tums, os-cal , caltrate, and viactiv. These may include additional vitamin D to aide absorption.

The problems we usually encounter after weight loss surgery are with B vitamins, iron and calcium deficiencies. We monitor a complete blood count (CBC), comprehensive chemistry, iron and B12 level at 6 months, 12 months and then yearly to assess nutritional needs and make adjustments to maintain good health.

DO NOT FAIL TO TAKE YOUR SUPPLEMENTS AND BE MONITORED ON A YEARLY BASIS, OR PERMANENT IRREVERSIBLE DAMAGE COULD OCCUR!

Dealing with Emotional Hunger

Atlanta Bariatric Support Group

J. K. Champion MD FACS and Susan Champion

Hunger and eating often have nothing to do with food in patients who have the metabolic disorder called “morbid obesity”. Recognition of the lack of association between “head hunger” and a physical need for nutrition is an important step in developing a successful approach to maximize weight loss after bariatric surgery.

“Head hunger” is a popular term discussed on Internet support groups describing a real entity, which is better classified as “emotional hunger”. Food is comforting and can serve the same purpose as a drug in dealing with our emotions. This action is usually sub-conscious, but becoming aware and recognizing the behavior gives patients the power to change old habits. This process of regaining control over your life is called “behavior modification”, and it is crucial to long-term success after weight loss surgery.

The disease of morbid obesity has slowed the body’s metabolism down to the point that most people need only 1000-1200 calories daily to maintain their weight after bariatric surgery. They don’t have the luxury of eating chocolate when sad, or nervously snacking on junk food when dealing with stress, anger, or boredom. Many patients with morbid obesity are not over-eaters, but are “foragers” or “grazers”, who eat not when they are hungry, but when they are stressed emotionally. This insidious weight gain is usually around 10 pounds per year, which over a decade adds up to being 100 pounds overweight again.

Current bariatric operations (Roux gastric bypass, VBG, or Lap-band) rely on a small gastric pouch to severely limit or restrict food intake to aide in weight reduction. This limitation on food intake can create a large “void” or “hole” in a person’s ability to emotionally handle the trials and tribulations of everyday living if food has been a method of coping with stress. The utilization of food to deal with stress has nothing to do with hunger, but the brain often interprets it as hunger, because it is the only way a person may know to deal with stress. The ability to deal with sadness, anger, frustration, or boredom is called “coping skills”, and it is a learned behavior, not something we are born with like brown eyes or blond hair.

There are three changes in your life, which need to occur after bariatric surgery in order to realize the full benefit of the operation and maintain weight loss long term.

One: CHANGE YOUR EATING PATTERN:

(3 meals per day and 1 snack on a set schedule 4-5 hours apart)

The principal pattern for eating before surgery is people eat whenever they are hungry or believe they are hungry. This may be 6, 8, or 10 times per day of small amounts of high calorie junk food (carbohydrates or fats). Eating is often not related to a physical need for food, but rather in response to a mental or emotional craving for the act of eating and the comforting effect it produces. In other words, we use it to make us feel better mentally. This is emotional hunger. Ask yourself; “Am I eating this because I’m hungry, or because I’m angry, sad, or bored?”

The gastric pouch must be filled with a small amount (8-12oz) of fibrous bulky food every 4-5 hours, and remain in the pouch for at least 30 minutes to relieve physical hunger and control appetite. This means eating on a set schedule, by the clock !! It does not mean eating whenever you think about or obsess about food. It does not mean skipping meals or making excuses. It does not mean drinking fluids with meals to wash the pouch out. It does mean following directions and changing a behavior, which endangers your health and shortens your life expectancy.

TWO: CHANGE YOUR ACTIVITY PATTERN:

(exercise 5 days per week for 30 minutes)

This is a major compliance issue for post op patients. Exercise improves your energy level, releases endorphins, which reduces stress and improves your mood, it builds muscle mass, which burns more calories and tightens loose skin, and it resets your body’s metabolic rate to a higher level to drive weight loss. This requires action on a patient’s part, to set aside time to exercise and to repeat it enough to make it a habit.

THREE: CHANGE THE WAY YOU DEAL WITH STRESS

(develop coping skills to deal with stress thru outside advice)

If we could change on our own, we would! All people have stress and frustration in their lives, as it is a part of daily living. In addition, change brings on stress, so post op there are many bridges to cross in regards to food, exercise, work, and personal relationships. Many people do a poor job dealing with stress and may turn to food, which is comforting and makes us feel good. Unfortunately for morbid obese patients, food has become self destructive, and cannot be used to deal with emotional hunger. Individual or group counseling can provide insight into ways to deal with stress in a healthy fashion. Outside advice is like a mirror held up in front of us so we can see our faults and ways to change. Suggestions to deal with stress constructively may include developing new hobbies or activities, or the development of new relationships. Attendance at support groups, asking questions, talking to others and sharing your own experiences helps not only yourself, but also others present in developing a new approach to life. Remember you don’t have to accept all outside advice, just be open to look and see if it fits your situation and can it help. Instead of trying to compare and see how you’re different, look for ways how you are like others and can use their experience to grow.

The overall theme of change is activity. Success depends on action on the part of the post op patient. Relying on the bariatric operation to “do all the work” without changing eating habits, exercise levels, or ability to manage adversity, will result in failure long term. Emotional hunger will create a void, which will demand to be filled.

Will you fill the void with calories or action?

Getting Started on the Road to Improved Weight Loss and Health

J. K. Champion MD

Maximizing weight loss after bariatric surgery is dependent on changes in diet, and the addition of regular exercise. Exercise is not a natural activity for most people, and our current society, workplace and lifestyle doesn’t encourage or promote it. Exercise must be practiced and learned until it becomes a habit which is incorporated into your daily routine. Experts agree the key to success is to start slowly and increase activity gradually until exercise becomes a part of your lifestyle. The problem for many patients is motivation and confusion over how to get started on a new activity.

Benefits:

Regular exercise has multiple health benefits for bariatric surgery patients such as:

1. Reducing anxiety and depression by increasing the body’s natural production of endorphins which are chemicals our bodies produce to naturally relieve stress and pain.

2. Improves sleep

3. Rebuilds muscle mass which is lost after surgery. 25% of weight loss after bariatric surgery is muscle. Muscle burns more calories and increases the metabolic rate which improves weight loss as much as 15%.

4. Reduces risk of osteoporosis, which is thinning of the bones and can lead to fractures of the hip or spine later in life. This is particularly important after the gastric bypass which can reduce the absorption of calcium, even with supplements.

5. Reduces boredom and is a great outlet for anger and stress.

6. Conditions the heart and lungs to improve stamina and endurance.

7. BETTER WEIGHT LOSS!!!!

GETTING STARTED:

A. Start Slow

We recommend beginning your exercise program when you return to your room after surgery by getting up and walking. Walking is a good exercise for the first 3 weeks or until you improve your endurance. Start with a baseline walk which you “time” to see how long you can walk until you tire or become short of breath. Continue this walk 1-2 times daily and add 1 minute per week until you can reach 30 minute. Patients with arthritis or severe obesity may need to consider “low impact” alternatives to reduce the stress on their joints. Alternatives include water aerobics, a recumbent bike, or the elliptical trainer.

The use of a pedometer, which is a small inexpensive device ($10 in our office or at a sporting goods store) that clips on your clothes to measure the numbers of steps walked, can be a valuable aide to allow patients to accurate judge the extent of their exercise and progress obtained. We recommend working up to 10,000 steps per session at least 3 days a week to influence weight loss. This will be about 5-6 miles and will take at least an hour to accomplish. Any less than this commitment will not aid weight loss.

Ultimately bariatric surgery patients need to add aerobic activity to their program. This is exercise which utilizes oxygen to burn calories and involves increasing your heart rate and “sweating”. Walking, even on a treadmill, is not aerobic exercise, and weight lifting, while important to add, is also not aerobic activity. Check with our exercise class instructor or a personal trainer for advice and specific recommendations.

B. Use a Group or Exercise Friend

Getting motivated and “sticking” with the program on a regular basis can be difficult at first. Many patients report they are more likely to participate if they sign up for a regularly scheduled class, or have an exercise buddy who is also depending on them to attend the activity.

Group activities and classes add a social side to the exercise and they force patients to go outside the home and meet new people. Prior to surgery many severely overweight patients are “home bodies” and avoided social activity due to lack of self-confidence or embarrassment over their physical appearance. Attendance at our support group exercise classes allows you to meet and associate with other patients who are experiencing the same trials and tribulations, as well as improving compliance with your exercise program.

C. Add Strength Training

Approximately 25% of weight loss after bariatric surgery is muscle and needs to be rebuilt with strength training and weight lifting. Muscle burns more calories (increases the metabolic rate or turns your body’s thermostat up) and improves weight loss, which is why men tend to lose more weight at a faster rate than women. In addition, as we all age we tend to lose muscle mass which results in reduce flexibility and weakness.

Strength training doesn’t require “bulking up” to look like a weight lifter. Resistance training with low weights and multiple repetitions will suffice. An additional benefit is strength training rebuilds bone density and aids in preventing osteoporosis.

CONCLUSION:

Bariatric patients lose weight and keep weight off long term not simply by dieting, but by changing their lifestyle. Reducing portion size due to the small gastric pouch and making better food choices with reduction of carbohydrates and elimination of sweets is important, but must be combined with a significant change in activity level to succeed long-term.

Now our Bariatric Chicken Satay recipe is also perfect for multiple servings, guests, family and kids will love it too!! You will enjoy the rich spicy peanut buttery flavored sauce and it is fun for little ones to just dip the chicken strips.

Chicken Satay Bariatric Recipe

It is simple to make and it is time to enjoy the new you So get out the grill!! No grill? Try using George Forman’s or a iron skillet. This is especially fun when you want to bring some summer flavor anytime of the year. Serve it with a side of cut up cucumbers and onions and a colorful salad*.

HINT: *I strongly recommend “Feast from the East Sesame Dressing” from Costco. It has a great oriental flavor  which will be a  FANTASTIC compliment to the Bariatric Chicken Satay!!! It is low calorie, no chemicals and no sugar perfect any day of the week

Recipe Ingredients

• 1-2 pounds boneless skinless chicken breast – slice into bit size strips
• 5 heaping tablespoons organic sugar free peanut butter – the crunchier the better for presentation.
• 1/3 cup of canned LITE coconut milk – sugar free and no fat
• 1 tablespoon crushed garlic
• 4 tablespoons Bragg’s Liquid Amino’s (Whole Foods, Ralph’s, Von’s or Publix’s will have it) Bragg’s Liquid Amino Acids is the best!! Liquid Amino’s Acid’s is 100% soy sauce but better. It has zero calories, zero sugar and 100% BETTER tasting then all the artificial soy sauces!! You will love it!! Super condiment for anyone after Bariatric Surgery
• 2 teaspoons Red Curry or Chili – this adds the spicy hotness to the recipe so use as little or as much as you wish.
• 1 scallion for a garnishment

Preparation: 15 minutes

First put about 8 skewers in water and soak!! (or save the skewers for after grilling and use like tooth picks)

Cut the chicken into bite size pieces.

Warm (preferably in a sauce pan) the crunchy  peanut butter, add garlic, Liquid Amino, chili flakes and add enough coconut milk only to thin the peanut butter to be more creamy).

Put the chicken on skewers by threading through the pieces. (**Many Chicken Satay Recipes will suggest to soak the chicken in some of the peanut sauce. I would suggest to save on wasted calories and maybe soak in some Liquid Aminos to darken the chicken and save the sauce for dipping)

Place the chicken on a grill. Cooking both sides. This should only take about 5 minutes in a George Foreman and 15 minutes on the grill. Make sure to cook thoroughly!

Finish by drizzling  some sauce over chicken and save the remainder for dipping sauce. Slice one scallion and garnish your dish.

Enjoy

Makes 8 servings.

Nutrition Information per 3/4 cup of Chicken & using the lowfat, no sugar ingredients:

• Calories: 230
• Calories from fat: 5
• Cholesterol: 119 mg
• Carbohydrates: 0g
• Protein: 46g

Thanks, Gregory! Expect more Bariatric Post-op Recipes to come because even after Bariatric Surgery you CAN still be wonderful cooks, hosts, entertainers and your guest will be thrilled!!

Question: How do you spell Success?

Answer:

1.) Eat by the Clock: Letting your body know when it can expect food , allows it to take what it needs and get rid of the rest. In turn, your body will then turn to fat stores for energy. Thus, burning fat for fuel! (** Additional resource: Post Operative Diet instructions for after Weight Loss Surgery)

2.) Just say NO to Drinking at Mealtime: You and your pouch need to feel full and satisfied! So don’t wash away all that hard work by flushing your food out of your pouch with liquids! Let your pouch empty on its own and this will keep hunger and grazing far from the equation!

3.)Take Vitamin-Calcium Supplements Daily:    – Two (2) Flintstones Chewable with iron—Three (3) Tums daily for calcium—Two (2) Feosol if female until reaching menopause

4.) Annual Weight and Labs Contact Dr. Champion’s office for more about your annual tests

5.) Your Daily Dose of Water and Exercise

6.) Attend Your Local Support Group: Some of our most successful patients attend support groups on a regular basis.

The answer is no.

Prescription Medications and Drug Absorption

Patients who undergo a Lap – Band procedure will not have any of the small intestines bypassed, so they shouldn’t worry about medication absorption. Many will ask why we place them on supplemental vitamins and calcium if the upper portion of the small bowel is not bypassed like after the Roux-en-Y Gastric Bypass. The answer to that question is many patients don’t eat a balanced diet which is high in iron such as green leafy vegetables, or avoid some food groups such as milk products which are high in calcium. About one out of every three Weight Loss Surgery patients are found to have low iron, calcium or “B” vitamin on the pre-op labs we perform. In addition over 50% of women over age 50 who haven’t had weight loss surgery will develop osteoporosis in their lifetime, so taking supplements is a good idea.

Gastric Bypass patients do have around 20% of the small bowel bypassed along with the portion just beyond the stomach called the duodenum. This will decrease the absorption of iron, calcium and “B” vitamins, so they must take supplements to remain healthy. This bypassed intestine only represents around 20% of the bowel, so medications can be absorbed normally in the remaining 80% of the distal bowel. No medications, vitamins, or nutrients are absorbed in the stomach. It simply serves as a mixer to grind up the food particles into smaller pieces. This is why you must chew your food until it is almost liquid to make up for the bypassed stomach.

We are not aware of any medications that are absorbed better or worse after Gastric Bypass Surgery. We occasionally see a reduction in prescription thyroid medications, but we believe this is due to a change in the patient’s metabolism and weight loss, not a change in absorption. Requirements for other medications like for diabetes, high blood pressure or cholesterol may also decrease after Gastric Bypass due to weight loss and changes in the body’s metabolism, but it is not due to a change in absorption. Birth control pills are absorbed normally, but must be taken as prescribed. Fertility often increases with weight loss, so remember to be diligent with birth control methods the first 18 months. All methods of birth control including the pill have a known failure rate of at least 1%.

So remember, take your medication as prescribed and do not make adjustments or changes without clearance from either your Primary Care Provider or Dr. Champion. Please call our office if you have any questions.

Implantable Gastric Stimulation to Achieve Weight Loss in Low BMI Patients:

Early Clinical Trial Results

Abstract:

This paper reports our early outcomes with Implantable Gastric Stimulation (IGS) to achieve weight loss in low BMI patients.

After prescreening potential candidates with a selection algorithm, 24 patients with a low BMI (30-34.9) underwent IGS implantation at two centers. There were 21 females and 3 males, mean age 43 (range 32-60), mean BMI 33 (range 30-36), and mean weight 92 Kg (range 80-117).

At six months post-op there have been no serious adverse events related to the device. Mean % Excess Weight Loss (EWL) was 5.9% with three patients explanted due to non-compliance. Mean waist circumference decreased 5.8 % which was significant (p=.009). A subset of nine patients (37.5%) lost more than 10% EWL (mean = 20.1%).

A subset of low BMI patients lost a clinically significant amount of weight with IGS within six months. Further study is required to better identify potential candidates for this novel approach.

Background:

Current approaches for surgical treatment to achieve weight loss rely on recommendations from the NIH Consensus Conference in 1991 which recommended Vertical Banded Gastroplasty or Roux-en-Y Gastric Bypass as a possible treatment option in patients with a body mass index (BMI) of 40 or greater, or in patients with a BMI from 35-39 if they exhibited a significant medical co-morbidity as a result of their obesity [4]. These two standard procedures rely on gastric restriction or nutrient malabsorption to achieve weight loss, and while successful to varying degrees, they are associated with a definite surgical morbidity and mortality which restricted their utilization to individuals who were otherwise at significant life threatening risks as a result of their medical condition [1,3,6]. There has not been an update or re-evaluation of this recommendation in the past 14 years, despite the introduction of minimally invasive approaches to standard operations and the development of innovative approaches such as the laparoscopic adjustable gastric band and Implantable Gastric Stimulation (IGS), which reduce some of the risks associated with open surgery or stapling procedures [5,7].

Implantable Gastric Stimulation (Transneuronix, Mt Arlington, NJ) offers a novel approach which has demonstrated in two FDA clinical trials in the United States and in a multi-center European study to be safe and to reduce appetite and increase satiety in a subset of morbidly obese patients who have undergone implantation [2,7]. Based on an analysis of these early studies a screening algorithm (Baroscreen™) was developed in an effort to better identify patients who are likely to respond to this technical innovation [7].

Currently there are no established and widely accepted bariatric surgical treatments for patients with a BMI of 30-35. Many of these “low BMI” individuals either have medical co-morbidities associated with their obesity or will continue to gain weight and develop significant co-morbidities before they qualify for a standard bariatric surgical procedure which involves stapling or banding the stomach under NIH criteria.

This paper reports the early outcomes at six months for a FDA clinical trial of Implantable Gastric Stimulation in low BMI patients employing a screening algorithm (Baroscreen™) to improve clinical responders for weight loss.

Methods:

This was a non-randomized open label pilot study to evaluate the safety and efficacy of the Implantable Gastric Stimulator in a population of patients with a BMI between 30 and 35, conducted in accordance with a FDA Investigational Device Exemption and consistent with the Helsinki Declaration. Both sites received IRB approval from their respective institutions and patients gave informed consent to participate in the clinical trial. Primary efficacy endpoint was defined as 10% total body weight loss within the two year follow-up period.

Potential candidates were screened with the Baroscreen™ algorithm which incorporated demographic data, measures of obesity and the Rand Medical outcomes SF-36 Health Survey. In addition the screening process incorporated a binge eating questionnaire and a psychological evaluation.

Twenty four subjects underwent implantation at two sites, and the cohorts were similar for age, BMI and weight (Table 1). There were 21 females and three males, mean age of 43 years (range 32-60), mean BMI of 33 (range 30-35.6) and mean weight 92 Kg (range 80-117). The procedure incorporated a totally laparoscopic approach which utilized the Transcend IGS System with two bipolar leads positioned sub-serosally on the lesser curve of the stomach, at or near the pes ancerinus (Figure 1). The pulse generator was implanted sub-cutaneously on the fascia of the left abdominal wall, usually below the waist line in the lower abdomen.

The devices were activated at 14 days post-implantation, and then patients are seen on a monthly basis for the first year and every other month the second year. Patients were instructed on a 500 calorie energy deficient diet and exercise program. Monthly post-op visits were scheduled which incorporated monitoring of outcomes, re-programming to optimize satiety, counseling with the dietician and support group meetings.

Statistical analysis was performed with paired t-test and significance defined as p < .05.

Results:

Eighty two patients were screened with the Baroscreen™ algorithm and 48 (58.5%) were selected initially as responsive to gastric stimulation, with 24 consenting to implantation and participation in the clinical trial. The clinical trial protocol required strict completion of all pre-operative testing and implantation within a 30 day window, so half our candidates were unable to comply due to time constraints and were lost to the study.

Follow-up and outcomes are reported at six months with three patients explanted prior to the six month visit for non-compliance with the clinical protocol for visits and monitoring. One explant occurred at 6 months in a patient who had lost 6.0% EWL, but required an MRI for shoulder surgery and requested to be dropped from the study. The other two explants occurred in patients gaining weight (2.8% and 14.9%) who failed to keep post-op appointments and complete testing protocols.

There were no deaths or serious adverse events related to the device. One patient experienced a stroke unrelated to the IGS and recovered uneventfully. The adverse events reported for more than 5% of patients are listed in Table 2 and all events resolved.

Mean %EWL at six months for the group as a whole was 5.9%, with a subset of nine patients (37.5%) losing at least 10% EWL with a mean of 20.1% EWL. Overall 14 patients lost weight (mean 13.9%) and 10 patients gained weight (8.2%) including the three explanted patients as listed in Table 3. Mean percent change in waist circumference was 5.8% which was significant (p = .0009).

Comparison of outcomes at six months between centers was not significant, p = .088 (Table 4).

Discussion:

The “Holy Grail” of bariatric surgery is the development of a screening tool to identify compliant and responsive candidates prior to surgical intervention. All weight loss surgeries have a definite failure rate, and the failure rate appears to be inversely proportional to the invasiveness and alteration imposed on the gastro-intestinal tract and directly proportional to the patient’s BMI and associated co-morbidities. The IGS system represents the least invasive, most reversible, and most adjustable bariatric surgical procedure so it is reasonable to assume the outcomes in terms of weight loss will be less and the failure rate will be increased compared to procedures like the gastric bypass, and these assumptions have been observed with %EWL of 20-25 and variable response rates of participants in previous U.S. Trials [7].

The Baroscreen™ algorithm was developed by a retrospective analysis of the first two U.S. IGS Clinical Trials in an attempt to reduce the wide variability of response to gastric stimulation for weight loss. The Baroscreen™ algorithm if retrospectively applied would have identified 33% of the participants in the second IGS trial as responders and this group lost greater than 30%EWL at 16 months post implantation [7]. Our subset of patients who lost more than 10%EWL at six months was 37.5% which was no better than the random selection process employed in the second Trial. The Baroscreen™ was based on analysis of morbidly obese patients with higher BMI’s, and doesn’t appear to accurately stratify the low BMI patients at this time. Data from this trial is currently being reviewed in an attempt to discern differences in responders and non-responders in the low BMI population in an effort to develop a new algorithm for this cohort.

Overall early weight loss outcomes were substantially below the norms bariatric surgeons have come to expect with gastric restriction or malabsorptive procedures, but not unreasonable in light of the primary endpoint of 10% total weight loss at 24 months. The subset of patients who lost more than 10%EWL had a mean %EWL of 20.1% which approaches the primary endpoint at the six month visit. There is clearly a cohort of responders to IGS for weight loss and the challenge remains to accurate identify them prior to implantation.

The safety of the IGS system was again demonstrated and it probably represents the safest bariatric surgical alternate currently employed raising hopes for a future mechanism to select patients for the least invasive procedure appropriate for their level of obesity.

Our early observation during this trial was that low BMI patients are a distinct subset of the obese, in the same manner that patients with a BMI greater than 60 pose a treatment challenge for more invasive bariatric procedures. Two issues make treating this group more difficult in our entirely subjective opinion. One; most of these candidates are on a self imposed restricted diet, and are already restricting calorie intake. They frequently skip meals or fast which lowers their metabolic rate and makes losing weight initially more difficult. They haven’t “given up” on dieting the same way most of our morbidly obese patients have prior to surgery. Two; the IGS system has no negative reinforcement mechanism (vomiting or dumping syndrome) to force patients to change their eating behavior. The IGS system output can be turned up to make patients retch in the office, but the parameters are adjusted to increase satiety at a subconscious level which is a subtle prompt in a population with recalcitrant ingrained behaviors with food, and an aversion to exercise in any form.

In summary, the IGS system appears to be safe in a low BMI population for weight loss, but only approximately one third of patients experienced more than 10%EWL at six months despite a screening algorithm to improve outcomes. Further study is required to improve outcomes for the IGS system in low BMI patients.

References:

1. DeMaria EJ, Sugerman HJ, Kellum JM (2002) Results of 281 consecutive total laparoscopic roux-en-y gastric bypasses to treat morbid obesity. Ann Surg 235: 640-647.
2. Luca MD, Segato G, Busetto L, Favretti F, Aigner F, Weiss H, Gheldere C, Gaggiotti G, Himpens J, Liamo J, Scheyer M, Toppino M, Zurmeyer EL, Bottani G, Penthaler H (2004) Progress in implantable gastric stimulation: summary of results of the European multi-center study. Obes Surg 14: S33-S39.
3. Mason EE, Doherty C, Cullen JJ (1998) Vertical gastroplasty; evolution of vertical banded gastroplasty. World J Surg 22:919-924.
4. NIH Consensus Statement. Gastrointestinal Surgery for Severe Obesity (1991) Ann Intern Med 115:956.
5. Obrien PE, Brown WA, Smith A (1999) Prospective study of a laparoscopically placed adjustable gastric band in the treatment of obesity. Br J Surg 85:113-118.
6. Schauer PR, Ikramuddin S, Gourash W(2000) Outcomes after laparoscopic roux-en-y gastric bypass for morbid obesity. Ann Surg 232:515-29.
7. Shikora SA (2004) Implantable gastric stimulation for the treatment of severe obesity. Obes Surg 14:545-548.

Table 1

Enrollment and Demographics

Table 2

Adverse Events Reported in more than 5% of Subjects

.

Table 3

GA = Atlanta, Georgia: FL = Lauderdale Lakes, Florida

Table 4

p = .88

Legends

Table 1: Enrollment and Demographics

Table 2: Adverse events reported in more than 5% of subjects

Table 3: Percent Excess Weight Loss or Gain for Each Patient

Table 4: Comparison of Outcomes between Centers

Figure 1: Position of leads on stomach

Figure 1

Position of Leads on Stomach

J. K. Champion MD FACS, Clinical Professor of Surgery, Mercer University School of Medicine

Director of Bariatric Surgery, Emory-Dunwoody Medical Center in Atlanta Georgia USA

Obesity has reached epidemic proportions in the United States and Western Europe in the past decade, and has now begun to effect Asian populations as high calorie convenience “fast foods” and lack of exercise become more common in modern society. Morbid obesity now occurs in approximately 5% of western populations, and weight loss surgery is increasingly being utilized to treat the issue successfully because medical approaches have demonstrated a 95% long term failure rate. This presentation reviews the currently established surgical options for bariatric surgery with the history of their evolution, and future areas for development and research.

Current operations for weight loss are based on two mechanisms of action: either gastric restriction or intestinal malabsorption, or a combination of the two. Gastric restriction relies on a small proximal gastric pouch of less than 30 cc and stabilization of the outlet with a prosthetic band. Examples include the Vertical Banded Gastroplasty (VBG) and the Laparoscopic Adjustable Gastric Band (Lap-band) or Swedish Band. Gastric restrictive procedures are simpler to perform with less risk, but are associated with less weight loss and higher revisions rates compared to other bariatric procedures.

The Roux-en-Y gastric bypass combines gastric restriction with some intestinal malabsorption to increase weight loss, by excluding a length of proximal small bowel from the common digestive tract. Controversy exists over the appropriate length of the small bowel bypass and technical aspects of the procedure due to a lack of prospective controlled trials to objectively compare outcomes with changes in technique. Hybrid operations result in greater weight loss and more sustained weight loss, but are associated with greater risk, including micro-nutrient deficiencies and difficulty accessing the distal stomach.

Purely malabsorptive procedures like the Bilio-pancreatic Diversion (BPD) and Duodenal Switch (DS) utilize a long bypass of the small bowel to the terminal ileum to form a common channel for digestion of only 50-100 cm. While popular in Western Europe and certain limited centers in the US, they are considered experimental by most bariatric surgeons due to their high risk of chronic diarrhea and protein malnutrition.

Laparoscopic approaches to perform all the currently accepted bariatric operations have led to an exponential increase in patient and surgeon interest since 1995. The laparoscopic approach has reduced wound morbidity and recovery time from surgery.

Future areas for expansion and research include the novel introduction of Gastric Pacing and Vagal Nerve Stimulation for weight loss utilizing an implantable gastric stimulator. Endo-luminal procedures for gastric restriction which will be accomplished by a totally endoscopic approach are in the development stage and will probably be introduced with the next 12-24 months.

The field of Bariatric Surgery is currently undergoing an evolution towards less invasive techniques with a variety of opportunities for research and development.

Author: J. K. Champion M.D., (www.DrChampion.com)

Department of Surgery, Mercer University School of Medicine

Atlanta, Georgia

LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS WITH THE LINEAR ENDOSTAPLER TECHNIQUE.

Purpose:  Early reports of laparoscopic gastric bypass techniques utilized a circular stapler to form the proximal anastamosis which many surgeons found challenging.   I modified the approach in 1997 to a totally closed laparoscopic linear stapler technique, and this paper reviews that experience.

Roux en-Y

Methods:  A divided proximal Roux-en-y gastric bypass was performed on 211 patients with a 100 – 150 cm limb length.  There were 189 females and 22 males, ages 16-64 (mean 39 years), with mean weight of 136 kg (range 96-206) and mean BMI of 50.3 (range 38-72).  Follow-up occurred in 85% of patients and averages 18.9 months (range 1-34).

Results:  Closed laparoscopic gastric bypass was attempted in 218 and completed in 211 patients (one conversion to open and six lap-assisted procedures).  Average O.R. time was 80 minutes and length of stay was 2 days.  There were no deaths.  Intra operative morbidity included one stapled NG tube.  Early morbidity (1.4%) includes one leak at the enteroenterostomy requiring operative repair and two patients requiring post op transfusion. Late morbidity ( 7.1%) includes six patients with anastamotic stricture requiring dilatation, two marginal ulcers, one patient under going reversal for noncompliance, and six bowel obstructions (5 internal hernia, 1 adhesive) requiring reoperation.  Percent excess weight loss at 12 months is 82% (range 44-102%).  There have been no hernias or wound complications.

Conclusion:  Early results demonstrate the Roux-en-y gastric bypass can be accomplished safely and effectively with a totally closed laparoscopic approach utilizing a linear endoscopic technique.