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| THE SURGICAL TREATMENT OF OBESITY Chapter 20 - Walter J. Pories, MD March 1, 2002 |
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Surgery today is warranted only for morbidly obese, individuals who have a Body Mass Index (BMI) > 35, i.e. who exceed their ideal body weight by at least 100 lbs. Weights exceeding 500 lbs. are not unusual. The term "morbid obesity" is often criticized because it implies that the disease is "mortal" or "fatal". Unfortunately, the term fits: the severely obese die early, usually of diabetic, cardio-vascular, or pulmonary complications. In the Framingham study, for example, all of the subjects who were morbidly obese died prematurely (1). It may, however, be time to re-name the disease because, finally, there is an effective therapy. With surgery, most patients can be freed of their morbid state not only with durable weight loss but also control of the co-morbidities. This chapter will review morbid obesity, consider the various surgical approaches, and compare the outcomes of the common procedures. OBESITY, AN INCREASING, COSTLY, AND UNEXPLAINED EPIDEMIC About 300,000 adult deaths in the US are attributable to the disease at a cost of $99.2 billion per year or 11.0 of the US health care expenditure. In addition, the Federal Trade Commission estimates that Americans spend $33 billion per year for weight-loss products (4). The success of surgery in controlling the bulk, mortality, and the co-morbidities of morbid obesity have led to a rapid spread of bariatric surgery: 46,000 such operations were performed in 2001 while over 80,000 are predicted for 2002, still not enough to reduce the number of morbidly obese significantly. At an average cost of about $30,000 per operation, including hospital, physician, and medication expenditures, the cost of this therapy will be about $2.4 billion next year. At the present time, there are not enough trained bariatric surgeons and adequately sophisticated facilities in the US to treat all the patients who would benefit from the surgeons. DEFINING MORBID OBESITY Another problem with the same BMI standard is applied to both sexes. Our data, still unpublished but based on hydrostatic weights collected in over 5,000 individuals, demonstrate that the current definitions are more stringent for males than for females. Fortunately, the concerns about the BMI values are more academic than of clinical relevance. Clinicians have little difficulty distinguishing the morbidly obese from the fit athlete. Most leading organizations of health professionals have adopted the classification adopted by the NIH Expert Panel on the Identification, Evaluation, and Treatment of Obesity in Adults, shown in Table 1 (5).
Most clinicians, however, have not adopted the "Class 1,2,and 3" definitions but, instead, prefer the terminology that considers a 5'4" individual overweight at 146 lb, obese at 175 lb, and morbidly obese at 205 lb. For a 6' person, the values would be 185 lb, 222 lb, and 259 lb. Morbid obesity includes Class 2 and Class 3. In spite of the various arguments about the term, "morbid obesity" remains the choice of clinicians because it is the term used for coding insurance claims and for searching the Index Medicus. Some bariatricians have also accepted the term "super-obese" but it is poorly defined: some reserve the term for patients who weigh over 350 lb. while others consider those with BMI values >40 in that classification. MORBID OBESITY: A SERIOUS DISEASE But the problems of morbid obesity are not merely those of an altered appearance and the difficulties of bulk. The danger of the condition is sharply increased by the co-morbidities of the disease listed in Table 2.
In addition, many of the morbidly obese are plagued by depression and socio-economic problems. Employment is often difficult to find because bias against the obese; a high rate of absenteeism due to illness; and issues of safety in the workplace. Similarly, those of us who care for the morbidly obese often hear poignant stories of sexual abuse and children so ashamed of their mothers that they beg them not to attend church or PTA. The Failure of Medical Therapy In the morbidly obese, however, these therapies are not effective. Why there is a failure to respond to the medical measures when excess weight exceeds 100 lb is not known, but the evidence was already strong enough in 1991 for the National Institutes Consensus Conference on the Surgery of Obesity to conclude that for morbid obesity, surgery is the only effective therapy. After a review of the national experience, the participants agreed that bariatric surgery, i.e., the surgery for obesity, was the therapy of choice for individuals with a BMI≥40 and for those with a BMI≥35 who also had the co-morbidities of the disease. These recommendations still stand today although there is strong support for the idea that for patients with type 2 diabetes, the requirement for a BMI>35 should be reduced to a BMI>30, given the excellent response of diabetics to the operation. BARIATRIC SURGERY: A VARIETY OF SURGICAL OPTIONS Bariatric surgery ranks among the major medical breakthroughs of the
last century. The first and most critical step was the recognition in
the 1950's that severe obesity was a disease serious enough to warrant
surgery. The initial solution was the intestinal bypass (Figure 1c), an
operation that produced dramatic weight loss by interfering with
digestion and absorption by shortening the functional gut.
Unfortunately, the procedure was followed by serious and sometimes fatal
complications including liver failure, kidney stones, hypo-proteinemia,
diarrhea, and electrolyte imbalances. Many had to be reversed.
Significant advances, with correction of each of the problems, have been made since those early days. Currently, the most commonly performed operations can be classified either as restrictive procedures that limit the volume and passage of food or as combined restrictive and malabsorptive that not only limit the volume and passage of food but also limit absorption and digestion through the exclusion of the gastro-intestinal tract from contact with food. Table 3 demonstrates these divisions.
Each of these operations has its advantages and disadvantages. In general, the restrictive procedures are technically less challenging, produce less weight loss, but also induce fewer metabolic changes, and have a lower chance of causing nutritional deficiencies than the combined restrictive and mal-absorptive procedures. Each of these operations will be reviewed below. The Restrictive Procedures
Adjustable Gastric Banding (AGB) is a new procedure that creates a small proximal gastric pouch with a silicone belt placed just below the gastro-esophageal junction. The procedure resembles the VBG in design. Proponents cite the ease of application with a laparoscope, the ability to adjust the opening, satisfactory weight loss of about 80% of that reported for the gastric bypass, and low mortality (<1%). Some surgeons, however, have given up the procedure because of difficulties with erosion or migration of the band. If the band is not placed well, expansion of the pouch can pull additional gastric tissue from below, producing a mushroom like reservoir that cannot empty. Infection of the port has also been a problem. In addition, application of the device can be followed by significant adhesions in some patients, making revision difficult. Results with the procedure differ: European centers report better results than those obtained in the US, but the American results have improved enough recently to allow the Food and Drug Administration to approve the device. The approach is promising. With additional experience it may become a reasonable alternative for selected individuals.
The restrictive and malabsorptive procedures
The procedure is technically demanding but can be done by an expert bariatric surgeon in less than an hour with low morbidity and mortality rates. The gastric bypass is the most commonly performed bariatric procedure today and regarded by some as the "gold standard". The recent demonstrations that the procedure can be done safely with a laparoscope with excellent outcomes and fewer hernias than the open approaches have made that technology even more popular. The duodenal switch is a more recent modification of the gastric bypass that reduces the size of the stomach and acid secretion by resecting the greater curvature to form a gastric tube with an estimated volume of 100 cc. In addition, the operation divides the proximal duodenum to bypass the proximal alimentary tract by joining the gastric tube, just beyond the pylorus, to a Roux-en-Y. The initial reports suggest that operation can produce satisfactory weight loss with good control of the associated co-morbidities. Anemia and hypoproteinemia may result from the short common channel and, occasionally require revision (10).
The bilio-pancreatic bypass, also known as the Scopinaro procedure is the most radical of the bariatric operations with its partial gastrectomy, cholecystectomy, and long intestinal bypass. The procedure, long reported to be successful in Italy, is gradually winning adherents in the US but the higher incidence of postoperative nutritional problems remains a serious concern.
THE KEY TO BARIATRIC SURGICAL SUCCESS: ATTENTION TO DETAIL Contra-indications: Patients with unresolved depression and/or substance and alcohol abuse do not do well after surgery. If there is a history of these illnesses, especially of a suicide attempt, an evaluation by a mental health professional is strongly advised before undertaking surgery. Other contra-indications are unrealistic expectations of the operation, failure to understand the procedure and its effects on food intake and retardation. A lack of family support or outright resistance by family members to the procedure are issues that need resolution prior to operation. Edentulous patients and those with dentures that do not fit well may have postoperative difficulties from blockage of the gastro-enterostomy because they tend to swallow their food in larger pieces. Age does not seem to be major factor: patients between the ages of 16 to 72 have been reported to do well. Support Systems: A bariatric surgical program is not a one-person undertaking. In fact, the surgical procedure is often the easiest part of the treatment. The effort requires a facility with the dedication and understanding required to manage the obese patient. Clinical and administrative personnel must appreciate that morbid obesity is a disease rather than a moral failing, that these bulky ill patients may require help even to get around in their rooms, and that families are often cruelly unable to understand their predicament. Beds, wheelchairs, stretchers, chairs, X-ray equipment, OR tables, retractors must be capable of managing patients who may weigh over 600 lbs. Endotracheal tubes, intra-venous lines, drains, and nasogastric tubes must be rigorously guarded because they may be difficult and sometimes impossible to replace if they come loose. Hospitals that choose to develop bariatric surgery programs find it useful to organize a bariatric care team: a full panel of specialists who are prepared to care for critically ill bariatric surgical patients in cardio-pulmonary failure, those with wound problems, those who need ventilator support, or those who present with chronic nutritional neuropathies. In addition, these patients often require additional support from social workers, physical therapists, dieticians, and other ancillary personnel. Group therapy sessions have also been helpful. Pre-operative Care: Patients undergoing bariatric surgery require several levels of evaluation and preparation. The initial phase is the decision whether the patient is a candidate for bariatric surgery, a process that frequently requires two or three visits to assess the patient, to explore the emotional and social aspects of the procedure, and to familiarize the family and friends with the operation, its potential complications, and outcomes. The second phase is the assessment of the patient as a surgical risk, often with the consultation of cardiologists, pulmonologists, and psychologists. In an uncomplicated patient, for example, a 29 year old woman who has a BMI of 42 and no co-morbidities, the same basic blood tests and imaging studies required for a cholecystectomy should suffice. On the other hand, a 500 lb. man with a history of smoking, previous myocardial infarctions, asthma, and chronic skin infections may take several weeks of preparation with diuresis, adjustment of medications, C-Pap ventilatory support, and psychiatric counseling over several sessions. Diuresis of massive amounts of water may be required; preoperative losses of 100 lbs. in an intensive care unit are not rare. There is an advantage in the slow evaluation. The operation can produce profound changes in life style, body image, and in family relationships. In our experience, the preoperative visits, often associated by discussions in the waiting room with patients who have undergone the operation, results in more realistic expectations and better understanding by the family members. Some individuals, however, require rapid evaluation and therapy. Patients in profound cardio-pulmonary failure may need rapid admission to an intensive care unit for diuresis of as much as a 100 lbs. of fluid, hygiene to clean up the skin, vitamin supplementation to manage malnutrition and prompt surgery to save their lives. Minimum preoperative tests include a complete blood count, a metabolic panel, bleeding indices, chest roentgenograms, and electrocardiogram. Patients are generally admitted the morning of surgery with the advice that they eat nothing after midnight and shower on the morning of surgery with an antibacterial soap. Our pulmonary emboli prevention program includes inflatable stockings and subcutaneous heparin. In most patients a nasogastric tube is inserted before anesthesia is started to prevent aspiration during intubation. In male patients who weigh over 400 lb., a prophylactic temporary tracheostomy may be wise; if the endotracheal tube is dislodged it may be difficult to replace. Anesthesia: Management of the anesthesia is generally remarkably uneventful in practiced hands, but it can be challenging due to the large amount of fat in these patients, the requirement for full relaxation, and their other co-morbidities. In our program, anesthesiologists see all patients who weigh more than 350 lb or who have severe co-morbidities in consultation prior to the day of surgery to help plan for their special needs including the decision whether a prophylactic tracheostomy is indicated. New programs are strongly advised to see the help of experienced anesthesiologists in their planning process. Blood loss is rarely a concern unless the spleen is damaged and cannot be salvaged. The administration of excessive crystalloids should be avoided. The operation: Bariatric surgery can be extremely demanding but, in most cases, proceeds remarkably smoothly in the hands of experienced teams. All patients are given preoperative, prophylactic antibiotics, usually a second or third generation cephalosporin within 20 minutes of the incision. If there is a delay in the surgery, a second dose of the antibiotic should be given. Some surgeons advise that the stomach be prepared as well with neomycin but the benefit of that prophylaxis is un-proven. Most procedures are still done through epigastric incisions that extend from the xyphoid to the umbilicus but the proportion performed with the laparoscope is growing rapidly. Exposure and good help are essential; with good vision and access these procedures go smoothly. Testing the staple lines and proximal anastomoses in the operating room with radio-opaque imaging and endoscopy can sharply reduce complications from leaks. The operations can often be completed in less than an hour; even laparoscopic approaches can be successfully done in less than two hours. Post-operative care: Even the superobese and patients with significant co-morbidities usually tolerate bariatric surgery remarkably well. Most patients are extubated within an hour after surgery and out of bed by evening. A limited upper gastro-intestinal contrast study is usually done on the next day. If there is no leak, the patient is started on sips of water. Diabetics who have previously been on insulin should be managed carefully with a "sliding scale" protocol to avoid hypoglycemia. It is not unusual for a patient to drop from 90 units per day to 8 units on the first post-operative day and require no more anti-diabetic therapy after four days. The first few days after surgery can be critical. Most patients have little difficulty but a few, about 5%, will develop tachycardia >120 and fever without appearing to be sick. In such cases, a leak or a RUQ infection need to be ruled out quickly with imaging studies or even exploration because the morbidly obese, especially those with diabetes, have little resistance and infections can progress rapidly. If there is any question, rapid re-exploration should be considered; an unnecessary operation causes little harm while an uncontrolled infection can be a fatal disaster. If a patient requires re-exploration and a leak is found, an attempt can be made to repair the opening but it usually fails. The essential step is thorough irrigation and wide drainage. Most patients so treated do well. Recently some groups have avoided re-exploration by the placement of a drain during surgery; others have managed some leaks successfully with laparoscopic irrigation and drainage. Such cases can be difficult challenges in judgment even for experienced laparoscopic surgeons; if there is a question, it is often safest to proceed with early exploration and drainage. Protocols vary but most surgeons stop the antibiotics after one or two days and allow oral intake by 24 -36 hours if the radiogram does not demonstrate an anastomotic leak. Patients are usually discharged between the second and fourth post-operative day. After discharge: Most surgeons keep the patients on Ensure Plus or a similar liquid nutritional product plus water for about two weeks. Full liquids are permitted for the next two weeks, and a regular, but selected, diet is started at about four to six weeks with a caution to chew the food thoroughly. Fish is generally well tolerated early if it is a "soft" and juicy fish, such as a broiled catfish. Chicken can also be offered early if it is cooked so that it is juicy and tender, i.e. as in a slow roast. It may take several months before meats are tolerated. For some reason, ground beef poses problems for some patients even a year after the surgery. Dietary supplements: Patients who undergo malabsorptive procedures must maintain intake of chewable mineral/vitamin preparations and vitamin B12. Women during childbearing years are also advised to take iron and calcium. To prevent the formation of gallstones, some patients are advised to take octreotide, but the drug is too expensive for some. One-third to two thirds of the patients will develop dumping, an unpleasant syndrome of sweating, dizziness, and tachycardia that follows the intake of sweets. The dumping disappears if the patients avoid sweets: a useful complication. Even though the initial pouch is about 20 - 30 ml, or the size of a man's thumb, most patients can eat a half hamburger, several French fries, and drink a small soft drink at one time within about six months after the operation. Curiously, it is rare to encounter a patient who complains about not getting enough to eat. Long-term care: Rigorous follow-up is important. Patients in our practice are generally seen at two weeks, one month, three months, six month and one year after surgery and once a year after that for life. In addition, in our unit, a member of the bariatric team, available by beeper, is on call continuously. The initial visits concentrate on wound care, nutrition, exercise, and adjustment to the physical and psychological changes associated with weight loss. Later visits emphasize nutrition, emotional problems, and cosmetic concerns about excessive skin. In most cases, the high degree of satisfaction and gratitude make these follow-up visits the most rewarding visits in a surgeon's practice. The importance of vitamin and mineral supplementation cannot be over-emphasized. After several months of unaccustomed wellness, patients often forget take the supplements, especially because the signs and symptoms of the deficiencies may take months or even years to appear. The consequences may be serious. Even though the complication is rare, we have seen two patients develop full-blown Korsakoff-Wernicke syndromes, blindness, and catastrophic muscle weakness who cleared only some of their disabilities when the vitamin and mineral deficiencies were corrected. OUTCOMES
Serious peri-operative complications occur at a rate of about 10%. The most common early complications include infection, anastomotic leaks, and pulmonary emboli. Late complications include incisional hernias in 25% of open procedures, failures of the staple lines in about 2 -5%, depression in about 25%, and nutritional deficiencies in about 25%. (11-28). The incidence of incisional hernias, however, falls to <2% when the procedures are done with the laparoscope. Severe nutritional deficiencies, such as Wernicke-Korsakoff Syndromes, are the most feared problem because the neuropathies may not be fully reversible if found late. COMPARING BARIATRIC OPERATIONS Comparison between the various operations is difficult because the reported series are small, measures of outcomes differ, populations are not comparable, and the procedures, even if named the same, are not identical. For example, two groups may both report their results with the "gastric bypass" but may differ significantly in the approach (open vs. laparoscopic), size of the pouches, the diameter of the gastro-enterostomies as well as the technique of the anastomoses (stapled vs. hand-sewn). Even so, some reliable statements about outcomes can be made. The perioperative mortalities of the procedures are generally comparable although the restrictive procedures may be slightly safer at <1% while the malabsorptive operations, for all patients, tend to range between 1 - 2%. Malabsorptive procedures generally produce greater weight loss than restrictive procedures but gain this advantage at the cost of nutritional deficiencies that can become dangerous if vitamin intake is not maintained. Bariatric surgery controls the co-morbidities of severe obesity to a degree that would not have been believed a decade ago. In our series at East Carolina University, with a 97.3% follow-up in 608 patients who underwent the Greenville version of the gastric bypass over 14 years, complete remission of type 2 diabetes was achieved in 83% with a reduction in mortality from diabetes from 4.5% per year to 1.0% per year. Hypertension is cleared in half; pseudotumor cerebri in all; arthritis in weight bearing joints is often reduced enough to allow a patient to escape a wheel chair and walk again unassisted. Laparoscopic surgery is now mature enough so that, in spite of the technical challenges of the technique, it produces results equivalent to the open approaches with less scarring and a markedly reduced incidence of incisional hernias in experienced hands. Maria and his associates (29) reported a series of 203 consecutive patients in whom they attempted laparoscopic gastric bypass between March 1998 and June 2001. Seven patients required converson to an open procedure (3.4%). No patients died. Length of stay averaged 4.8 days with 75% of the patients discharged within 3 days. Complications included 3 (1.5%) major wound infections, anastomotic leak with peritonitis in 11 cases (5.4%) of which 3 were managed non-operatively, four by laparoscopic repair/drainage, and three by open repair/drainage. Only two patients had anastomotic leaks in their most recent 100 patients. Data at 1 year after surgery, available in 46 of 63 (73%) of the patients, are shown in Tables 4, 5, and 6:
Most patients achieve their maximum weight loss within two years and may then drift upward by 5 - 10 %, remaining at about 100 lb below their original weight. There seem to be some differences in weight loss among patient groups: Caucasians seem to lose more weight than African-Americans; older women lose less than younger females. Patients who do not take their vitamin/mineral supplements lose less weight than those who do. Failures of the procedure, i.e., regain of the weight, are usually due to two causes: failure of the staple line or snacking such products as crackers, sweets, peanut butter, or soft drinks. Some regain due to a return to alcoholism. Weight gain is therefore an important indicator and the cause should be sought promptly. Re-operations are necessary in about 5 - 10% in most series. The procedures tend to be more difficult than primary operations and carry a somewhat higher complication and mortality rate. Good results are obtained when the re-operations address staple line failures, internal hernias, and recurrent bowel obstruction due to adhesions, but repairs solely of dilated gastro-enterostomies have not led to significant weight loss in our hands. A VIEW OF THE FUTURE The operations are still being modified and not fully mature. Even so, it seems likely that two basic procedures will survive: the gastric bypass with tailored lengths of intestinal loops and a gastroplasty, probably with an adjustable silicone band. In addition, the duodenal switch appears to be promising and gaining increasing acceptance. A secure evaluation of the procedures, however, cannot be accomplished until a national registry with large populations, standardized operations, and a clearly defined clinical lexicon is developed. In addition, follow-up rates of at least 90% over five years, and preferably ten years, will be needed to evaluate the long-term results. Until such a registry is founded and implemented, we can have intelligent guesses, but not much more. Finally, morbid obesity and bariatric surgery offer remarkable platforms for research. The conditions provide experimental windows we could only hope for: patients afflicted by a disease who can then be studied freed of that same disease. What an opportunity to make major advances in the study of some of our most serious diseases: diabetes, arthritis, asthma, hypertension, certain cancers, and endocrine disorders. |
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