Meta-Analysis: Surgical Treatment of Obesity

Context The effectiveness of surgical therapy in the treatment of obesity is unclear. Contribution Many published studies of obesity surgery have significant limitations, and case series make up much of the evidence. Evidence is complicated by the heterogeneity of procedures studied. However, surgery can result in substantial amounts of weight loss (20 to 30 kg) for markedly obese individuals. One cohort study documented weight loss for 8 years with associated improvements in comorbid conditions, such as diabetes. Complications of surgery appear to occur in about 20% of patients. Implications Those considering surgical treatment for obesity should understand that, although patients who have surgery can lose substantial amounts of weight, the evidence base for these treatments is limited. The Editors The prevalence of obesity in the United States is reaching epidemic proportions. An estimated 30% of individuals met the criteria for obesity in 19992002 (1, 2), and many industrialized countries have seen similar increases. The health consequences of obesity include heart disease, diabetes, hypertension, hyperlipidemia, osteoarthritis, and sleep apnea (3-7). Weight loss of 5% to 10% has been associated with marked reductions in the risk for these chronic diseases and with reducing the incidence of diabetes (8-14). The increasing numbers of obese individuals have led to intensified interest in surgical treatments to achieve weight loss, and a variety of surgical procedures have been used (Figure 1). Bariatric surgery was first performed in 1954 with the introduction of the jejunoileal bypass, which bypasses a large segment of small intestine by connecting proximal small intestine to distal small intestine. With this procedure, weight loss occurs secondary to malabsorption from reduction of upstream pancreatic and biliary contents. However, diarrhea and nutritional deficiencies were common, and this procedure was discontinued because of the complication of irreversible hepatic cirrhosis. With the development of surgical staplers came the introduction of gastroplasty procedures by Gomez in 1981 (15) and Mason in 1982 (16). In these early procedures, the upper portion of the stomach was stapled into a small gastric pouch with an outlet (that is, a stoma) to the remaining distal stomach, which limited the size of the meal and induced early satiety. These procedures were prone to staple-line breakdown or stoma enlargement and were modified in turn by the placement of a band around the stoma (vertical banded gastroplasty). Figure 1. Surgical procedures. The first gastric bypass was reported in 1967 by Mason and Ito (17). It combined the creation of a small gastric pouch with bypassing a portion of the upper small intestine. Additional modifications resulted in the Roux-en-Y gastric bypass (RYGB), a now common operation that involves stapling the upper stomach into a 30-mL pouch and creating an outlet to the downstream small intestine. The new food limb joins with the biliopancreatic intestine after a short distance. This procedure, performed laparoscopically or by using an open approach, generates weight loss by limiting gastric capacity, causing mild malabsorption, and inducing hormonal changes. A second common technique, particularly outside of the United States, is the laparoscopic adjustable gastric band. This device is positioned around the uppermost portion of the stomach and can be adjusted to allow tailoring of the stoma outlet, which controls the rate of emptying of the pouch and meal capacity. Another procedure, preferred by a number of surgeons, is the biliopancreatic bypass, which combines a limited gastrectomy with a long Roux limb intestinal bypass that creates a small common channel (that is, an intestine where food and biliopancreatic contents mix). This procedure can be combined with a duodenal switch, which maintains continuity of the proximal duodenum with the stomach and uses a long limb Roux-en-Y bypass to create a short common distal channel. These latter 2 procedures generate weight loss primarily through malabsorption. Recent worldwide survey data from 2002 and 2003 show that gastric bypass is the most commonly performed weight loss procedure (65.1%) (18). Slightly more than half of gastric bypasses are done laparoscopically. Overall, 24% of cases are laparoscopic adjustable band procedures; 5.4% are vertical banded gastroplasties; and 4.9% are biliopancreatic diversion, with or without the duodenal switch. In California, the number of bariatric cases increased 6-fold between 1996 and 2000 (19), from 1131 cases to 6304; an estimated 140000 procedures were performed in the United States in 2004. With this escalation in the number of procedures, there have been reports of high postoperative complication rates (20-24). Because of these reports and the increasing use of obesity surgery, we were asked to review the literature to estimate the effectiveness of bariatric surgery relative to nonsurgical therapy for weight loss and reduction in preoperative obesity-related comorbid conditions. We were also asked to compare outcomes of surgical techniques. This paper is part of a larger evidence report titled Pharmacological and Surgical Treatment of Obesity, which was prepared for the Agency for Healthcare Research and Quality and is available at www.ncbi. nlm.nih. gov/books/bv.fcgi? rid=hstat1a.chapter. 19289. Methods Literature Search and Selection We began with an electronic search of MEDLINE on 16 October 2002, followed by a search of EMBASE and subsequent periodic search updates (on 22 May, 2 June, 12 June, and 3 July 2003). We also assessed existing reviews of surgical therapy for obesity (10, 25, 26). Three reviewers independently reviewed the studies, abstracted data, and resolved disagreements by consensus (2 reviewers per study). The principal investigator settled any unresolved disagreements. We focused on studies that assessed surgery and used a concurrent comparison group. This category includes randomized, controlled trials (RCTs); controlled clinical trials; and cohort studies. A brief scan of the literature showed that these types of studies were rare. Therefore, we also elected to include case series with 10 or more patients, since these studies can be used to assess adverse events and could potentially augment the efficacy data from comparative studies. Publication bias is one potential limitation of analyzing the available literature because poor or negative results are not as likely to be reported as are successes or positive results. Extraction of Study-Level Variables We abstracted data from the articles, including number of patients and comorbid conditions, adverse events, types of outcome measures, and time from intervention until outcome. Detailed data were also collected on characteristics of the study samples, including median age, percentage of women, median baseline weight (in kilograms or body mass index [BMI]), percentage of patients with comorbid conditions at baseline (diabetes, hypertension, dyslipidemia, and sleep apnea), percentage of improvement or resolution of preexisting comorbid conditions, and median follow-up time. We also recorded whether the case series studies reported on consecutive patients. Choice of Outcomes The main outcomes of interest were weight loss, mortality, complication rates, and control of obesity-related comorbid conditions. We used the most commonly reported measurement of weight loss, that is, kilograms, which allowed us to include the greatest number of studies. Among 111 surgical studies reporting weight loss, 43 reported weight loss in kilograms or pounds, 17 reported excess weight loss or some variant, 46 reported both of these outcomes, and 5 reported neither. A total of 89 studies had sufficient data to be included in the weight loss analysis. Because weight loss achieves health benefits primarily by reducing the incidence or severity of weight-related comorbid conditions, we also compared the effects on these outcomes. Quality of life, an important outcome in assessing tradeoffs between benefits and risks, was reported infrequently. Statistical Analyses Because we included both comparative studies and case series, we conducted several types of analyses. The vast number of types of surgical procedures and technical variations required that we aggregate those that were clinically similar and identify the comparisons that were of most interest to the clinical audience. On the basis of discussions with bariatric surgeons, we categorized obesity surgery procedures by procedure type (for example, gastric bypass, vertical banded gastroplasty), laparoscopic or open approach, and specific surgical details such as length of Roux limb (see the larger evidence report for details). Analysis of the Efficacy of Surgical Weight Loss We extracted the mean weight loss and standard deviation at 12 postoperative months and at the maximum follow-up time (36 months). These times were chosen because they are clinically relevant and are most commonly reported. Of the 89 weight loss studies, 71 reported baseline BMI (average, 47.1 kg/m2), 16 reported baseline weight in kilograms or pounds (average, 123.3 kg), and 2 did not report either. The average age of patients was 38 years, and more than three quarters were women. For comparative studies that reported a within-study comparison of 2 procedures, a mean difference was calculated. Mean differences were pooled by using a random-effects model, and 95% CIs were estimated; the same method was used to determine a pooled mean weight loss for each group considering all studies combined. However, mean difference in weight loss was not calculated. Analysis of Surgery Mortality We recorded the number of deaths observed and the total number of patients in each procedure group. If the study self-identified the deaths as early or postoperative or as occurring within 30 days of the surgery, we termed these early deaths. If the