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National Institutes of Health Consensus Development Conference Statement

March 25-27, 1991

Gastrointestinal Surgery for Severe Obesity. NIH Consens Statement 1991 Mar 25-27;9(1):1-20.

Gastrointestinal Surgery for Severe Obesity. NIH Consens Statement Online 1991 Mar 25-27 [cited year month day];9(1):1-20.

Abstract

The National Institutes of Health Consensus Development Conference on Gastrointestinal Surgery for Severe Obesity brought together surgeons, gastroenterologists, endocrinologists, psychiatrists, nutritionists, and other health care professionals as well as the public to address: the nonsurgical treatment options for severe obesity, the surgical treatments for severe obesity and the criteria for selection, the efficacy and risks of surgical treatments for severe obesity, and the need for future research on and epidemiological evaluation of these therapies. Following 2 days of presentations by experts and discussion by the audience, a consensus panel weighed the evidence and prepared their consensus statement.

Among their findings, the panel recommended that (1) patients seeking therapy for severe obesity for the first time should be considered for treatment in a nonsurgical program with integrated components of a dietary regimen, appropriate exercise, and behavioral modification and support, (2) gastric restrictive or bypass procedures could be considered for well-informed and motivated patients with acceptable operative risks, (3) patients who are candidates for surgical procedures should be selected carefully after evaluation by a multidisciplinary team with medical, surgical, psychiatric, and nutritional expertise, (4) the operation be performed by a surgeon substantially experienced with the appropriate procedures and working in a clinical setting with adequate support for all aspects of management and assessment, and (5) lifelong medical surveillance after surgical therapy is a necessity.

The full text of the consensus panel's statement follows.

Introduction

In a 1985 National Institutes of Health (NIH) consensus conference, the health implications of obesity were established as including increased risk for cardiovascular disease (especially hypertension), dyslipidemia, diabetes mellitus, gallbladder disease, increased prevalences and mortality ratios of selected types of cancer, and socioeconomic and psychosocial impairment.

Risk for morbidity and mortality accompanying obesity is proportional to the degree of overweight. A simple means to define overweight is by the body mass index (BMI): [weight (kilograms)/height (meters)^2]. The BMI associated with lowest mortality is between 20 and 25 kg/m:^2. Approximately 4 million Americans have BMI's between 35 and 40 kg/m:^2, and another 1.5 million have BMI's over 40 kg/m:^2. A BMI of 40 kg/m^2 is roughly equivalent to 100 pounds overweight for an average adult male. Persons at the highest risk of morbidity and mortality can be categorized as having "clinically severe obesity," a term that is preferred to "morbid obesity." Patients with severe obesity are potential candidates for treatment by surgical procedures.

The ultimate biologic basis of severe obesity is unknown, and specific therapy directed to it, therefore, is not available. This disorder, nevertheless, is accompanied by a reduction in life expectancy, which is due in large part to significant comorbid associations in the form of metabolic abnormalities and several serious cardiopulmonary disorders. In addition, significant psychosocial and economic problems frequently are experienced by persons with severe obesity. These facts lend urgency to the effort to provide rational care for those seeking relief from effects of this condition.

A 1978 NIH consensus conference on surgery for obesity considered primarily intestinal (jejunoileal) bypass, which exerts its weight-loss effects through malabsorption, decreased food intake, and possibly other mechanisms. This operation was shown to be effective in some reported series of cases, but in many patients it was accompanied by serious complications. The 1978 conference highlighted the undesirable side effects of this operation, and its use has all but disappeared. In the past 10 to 15 years, other types of surgical procedures have been developed; these use reduction in gastric volume, gastric bypass, and other procedures. Mechanisms of weight loss with newer procedures, which may include both food aversion and malabsorption, have not been determined with certainty. Refinements in such procedures have led to reports of results superior to those seen with the earlier operation; however, side effects sometimes do occur, and in spite of weight loss, ideal body weight is rarely attained. The time has come to evaluate the objective evidence for these new surgical therapies.

To resolve questions relating to surgery for severe obesity, the National Institute of Diabetes and Digestive and Kidney Disease and the Office of Medical Applications of Research of the NIH convened a Consensus Development Conference March 25-27, 1991. After 2 days of presentations by experts in the field, a consensus panel representing the professional fields of surgery, general medicine, gastroenterology, nutrition, epidemiology, psychiatry, endocrinology, and including representatives from medical literature and the public, considered the evidence and agreed on answers to the questions that follow.

What Are The Nonsurgical Treatment Options For Severe Obesity And Their Consequences?

Nonsurgical approaches to treatment of clinically severe obesity include various combinations of low- or very low-calorie diets, behavioral modification, exercise, and pharmacologic agents. In addition to weight reduction regimens, comorbid factors such as hypertension, dyslipidemia, and diabetes mellitus can be treated by usual medical methods. Published studies of medical approaches to the treatment of obesity include few reports or indications of efficacy in persons with clinically severe obesity. The potential efficacy of these approaches in persons with this degree of obesity, therefore, must be inferred from evidence of their efficacy in less obese persons.

Nonsurgical treatment of clinically severe obesity aims to create a caloric deficit sufficient to result in both permanent weight loss and reduction of weight-related risk factors or comorbidity. The specific amount of targeted weight loss is defined on a case-by-case basis and does not necessarily require reduction to ideal body weight.

Very low-calorie diets (VLCD's) have been widely publicized as having dramatic success in the treatment of clinically severe obesity. Typically, these diets contain 400 to 800 kilocalories per day with increased protein and minimal fat in a solid or liquid form. Significant weight reduction, for example 20 kg over 12 weeks, can be expected. However, in the absence of successful behavior modification, most patients regain their lost weight within 1 year. Thus, although VLCD's used under close medical supervision often are effective in short-term treatment of clinically severe obesity, these diets alone generally have not been successful for achieving permanent weight loss. Combining a VLCD with intensive behavioral modification may be more effective than a VLCD alone for treating the severely obese patient. Although data on the use of this approach are few, some evidence suggests that initial treatment with a VLCD followed by intensive behavioral modification may result in sustained weight loss in highly motivated patients with clinically severe obesity.

Behavioral modification is a therapeutic approach based on the assumption that habitual eating and physical activity behaviors must be relearned to promote long-term weight change. Behavioral treatment also can be combined with a lesser degree of caloric restriction, although evidence of long-term efficacy of this more conservative approach in persons with clinically severe obesity is lacking. Although increased physical activity is recommended as a component of weight-loss programs, the role of exercise in promoting and sustaining weight loss has never been established.

Experience with drug therapy for clinically severe obesity has been disappointing. Although pharmacologic studies with anorexigenic drugs suggest short-term benefit, prolonged and sustained weight loss has not been proved with these agents. Drugs such as amphetamines and thyroid derivatives are unsafe and unapproved.

Medical complications of rapid weight loss may occur and are usually treatable. Electrolyte abnormalities and cardiac arrhythmias during administration of VLCD's generally can be avoided or corrected by the inclusion of high-quality protein and frequent physician surveillance. Recent studies have recognized that rapid weight loss may be associated with a substantial incidence of gallstones. Although there are no specific complications of behavior therapy, failure to achieve sustained weight reduction may heighten the patient's sense of personal failure and decrease the motivation for further medical therapy.

Limited success has been achieved by various techniques that include medically supervised dieting and intensive behavior modification. During such a treatment program, comorbidity factors such as hypertension, dyslipidemia, and diabetes mellitus can be treated by conventional medical therapy in the patient with clinically severe obesity. Although weight may be reduced acceptably, a major drawback to the nonsurgical approach is failure to maintain reduced body weight in most patients. The possibility should not be excluded that the highly motivated patient can achieve sustained weight reduction by a combination of supervised low-calorie diets and prolonged, intensive behavior modification therapy.

What Are The Surgical Treatments And Criteria For Selection?

A number of operations have been tried and discarded as inefficacious or because of complications. Two procedures dominate practice in the early 1990's and have advanced beyond the experimental stage.

Vertical banded gastroplasty  and related techniques consist of constructing a small pouch with a restricted outlet along the lesser curvature of the stomach. The outlet may be externally reinforced to prevent disruption or dilation.

Gastric bypass procedures involve constructing a proximal gastric pouch whose outlet is a Y-shaped limb of small bowel of varying lengths (Roux-en-Y gastric bypass).

Choosing between these procedures involves the surgeon's preference and consideration of the patient's eating habits. The somewhat greater weight loss after the gastric bypass procedure must be balanced against its higher risk of nutritional deficiencies, especially of micronutrients.

Biliary-pancreatic bypass includes a gastric restriction and diverts bile and pancreatic juice into the distal ileum. Experience with the procedure in the United States is limited.

Patient Selection

These surgical procedures are major operations with short- and long-term complications, some of which remain to be completely elucidated. There are insufficient data on which to base recommendations for patient selection using objective clinical features alone. However, while data accumulate, it may be possible in certain cases to consider surgery on the basis of limited information from the uncontrolled or short-term followup studies available. A decision to use surgery requires assessing the risk-benefit ratio in each case. Those patients judged by experienced clinicians to have a low probability of success with nonsurgical measures, as demonstrated for example by failures in established weight control programs or reluctance by the patient to enter such a program, may be considered for surgery.

A gastric restrictive or bypass procedure should be considered only for well-informed and motivated patients with acceptable operative risks. The patient should be able to participate in treatment and long-term followup.

Patients whose BMI exceeds 40 are potential candidates for surgery if they strongly desire substantial weight loss, because obesity severely impairs the quality of their lives. They must clearly and realistically understand how their lives may change after operation.

In certain instances less severely obese patients (with BMI's between 35 and 40) also may be considered for surgery. Included in this category are patients with high-risk comorbid conditions such as life-threatening cardiopulmonary problems (e.g., severe sleep apnea, Pickwickian syndrome, and obesity-related cardiomyopathy) or severe diabetes mellitus. Other possible indications for patients with BMI's between 35 and 40 include obesity-induced physical problems interfering with lifestyle (e.g., joint disease treatable but for the obesity, or body size problems precluding or severely interfering with employment, family function, and ambulation).

Children and adolescents have not been sufficiently studied to allow a recommendation for surgery for them even in the face of obesity associated with BMI over 40.

What Are The Efficacy And Risks Of Surgical Treatments For Obesity?

Issues of efficacy and risk in bariatric surgical procedures must be viewed in light of the fact that severe obesity is a chronic intractable disorder; any therapeutic program must, therefore, be lifelong.

While definitive therapy for severe obesity is not available, the surgical procedures in use can induce substantial weight loss, and this, in turn, may ameliorate comorbid conditions. Since short- and intermediate-term effects observed in several studies may relate to long-term benefits, further application and investigation of these operations are justified. It must be kept in mind, however, that long-term results are of critical importance and must be delineated. Of special note, many patient cohorts studied to date are not representative of the distribution of race, ethnic and cultural factors, and socioeconomic status among the severely obese population.

Efficacy of Surgical Treatments for Obesity

Comorbid Conditions
Weight reduction surgery has been reported to improve several comorbid conditions such as sleep apnea and obesity-associated hypoventilation, glucose intolerance, frank diabetes mellitus, hypertension, and serum lipid abnormalities. Whether beneficial effects in the various metabolic disorders are maintained long enough to prevent end-organ damage (e.g., renal disease, stroke, myocardial infarction, and heart failure) is not known.

Psychosocial Effects
Many patients report improvement in mood and other aspects of psychosocial functioning after these operative procedures. The degree to which these improvements are sustained is unknown.