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Obesity Surgery, 10, 391-401

Meta-Analysis

Bariatric Surgery for Morbid Obesity

Mark J. Monteforte, MD; Charles M. Turkelson, PhD

ECRI, Plymouth Meeting, Pennsylvania, USA*

Background: Bariatric surgery is a treatment for Key Words: Anastomosis, Roux-en-Y; gastric bypass;
severely obese patients. We examined the efficacy of gastroplasty; meta-analysis; obesity, morbid; bariatric
bariatric surgery, addressing three questions: 1) surgery; weight loss
“What is the overall weight reduction following
bariatric surgery?” 2) “What complications are asso-
ciated with bariatric surgery?” 3) “What impact does
weight loss have on obesity-related comorbidity?” Introduction
Methods: Fixed and random effects meta-analy-
ses were used to determine the amount of weight
reduction following bariatric surgery. The influence Obesity is a major health concern. Obese individu-
of a variety of co-variates that could affect study als are at increased risk of mortality and morbidity,
results was examined. Information from evidence- including hypertension, type 2 diabetes, coronary
based sources was used to explore the impact of
heart disease, stroke, gallbladder disease
weight loss on comorbidities.
Results: Meta-analyses results were affected by loss (cholelithiasis and cholecystitis), osteoarthritis,
to follow-up, and within-study heterogeneity of vari- sleep apnea, respiratory problems, and many types
ance. Therefore, results were pooled from studies with of cancer (including endometrial, breast, prostate,
complete patient follow-up. Meta-analysis of six stud- and colon). Obesity is also associated with compli-
ies reporting weight loss at 1 year and four studies cations of pregnancy, menstrual irregularities, hir-
with mean follow-up of 9 months to 7 years demon-
sutism, stress incontinence, and psychosocial impair-
strated BMI reductions of 16.4 kg/m2 and 13.3 kg/m2,
respectively. Weight reduction following bariatric ments (e.g., binge eating, body image perceptions,
surgery may be associated with improvements in risk depression, and social stigmatization). 1 Prevalence
factors for cardiac disease including hypertension, estimates for U.S. adults with a body mass index
type 2 diabetes and lipid abnormalities, and may (BMI) ³35 kg/m2 and ³40 kg/m2 are 8.0% and 2.8%,
decrease the severity of obstructive sleep apnea. respectively,2 and the relative risk for all-cause mor-
Conclusion: Bariatric surgery is appropriate for
tality is increased at BMI levels ³30 kg/m2.3
obese patients (BMI >40 kg/m2 or ³35 kg/m2 with obe-
sity-related comorbidity) in whom non-surgical treat- Nonsurgical approaches to treatment of clinical-
ment options were unsuccessful. Additional ly severe (morbid) obesity (BMI >40 kg/m2)
research is needed to examine the long-term bene- include various combinations of low-calorie or
fits of weight loss following bariatric surgery, partic- very low calorie diets, behavioral modification,
ularly with respect to obesity-related comorbidities. exercise, and pharmacologic agents.4 A major
drawback to nonsurgical approaches is their failure
to maintain reduced body weight in most obese
*ECRI is a non-profit health services research organization
that provides technical assistance to hospitals, health plans, patients. 4
and government agencies worldwide. Partly for this reason, bariatric surgery is a treat-
Reprint requests to: Charles M Turkelson, PhD, Chief Research ment option often recommended for severely obese
Analyst, Health Technology Assessment Group, ECRI, 5200
Butler Pike Plymouth Meeting, PA 19462-1298, USA. Tel: (610) patients (BMI >40 kg/m2 or BMI ³35 kg/m2 with
825-6000; fax: (610) 834-1275; email: eturkelson@ecri.org obesity-related comorbidity) who have had unsuc-

© FD-Communications Inc. Obesity Surgery, 10, 2000 391


Monteforte and Turkelson
cessful results with nonsurgical methods for weight capacity as mechanisms for weight reduction.
reduction. The extent to which surgical procedures Roux-en-Y gastric bypass (RYGBP) and distal
are used for the morbidly obese is suggested by (extended) Roux-en-Y gastric bypass (RYGBP-E)
data from the International Bariatric Surgery are examples of combination procedures.
Registry (IBSR). Malabsorptive procedures are those that reduce
In 1997, the IBSR reported data submitted by 50 nutrient absorption, typically by bypassing a part
surgical practices involving 75 surgeons on proce- of the small intestine. Measures of the effective-
dures performed from 1986 through 1995 on 14,641 ness of malabsorptive procedures were not ana-
patients. According to IBSR data, 84.7% of patients lyzed in this article.
received one of four surgical procedures: vertical Bariatric procedures may alternatively be classi-
banded gastroplasty (36.3%), Roux-en-Y gastric fied on an anatomic basis, depending on whether
bypass (29.5%), silastic ring gastroplasty (9.9%), or the operation involves the stomach, small intestine,
distal Roux-en-Y gastric bypass (9.0%). The authors or both. If one were to use such an anatomic clas-
did note, however, that there had been a recent sification system, then restrictive procedures would
increased use of gastric banding operations.5 be nearly synonymous with operations involving
The most obvious reported benefit of bariatric the stomach, malabsorptive procedures with opera-
surgery is weight loss. Published evidence for such tions involving the small intestine, and combina-
weight loss is largely from case series and uncon- tion procedures with operations involving both the
trolled clinical trials. Differences among these tri- stomach and the small intestine. The use of this
als mean that it is not simple to determine the aver- classification system would not greatly alter the
age weight loss that can be expected to result from results of our analysis.
surgery and, therefore, whether the surgery has a There is currently no uniform measure for report-
significant impact on obesity-related co-morbidi- ing weight loss outcomes. Studies of bariatric surgi-
ties. To overcome these difficulties, we used meta- cal procedures have reported weight loss in a num-
analysis to determine the overall amount of weight ber of different ways, including change in absolute
reduction following bariatric surgery. We also weight (pounds and/or kilograms), change in BMI
sought to determine whether the meta-analytically (kg/m2), percentage of excess body weight loss
determined weight loss following bariatric surgery (EBWL), or a change in ideal body weight (IBW).
has an impact on mortality and several obesity- In 1998, the National Institutes of Health (NIH)
related comorbidities, including hypertension, type recommended that BMI be used to classify over-
2 diabetes, lipid abnormalities, and sleep apnea. weight and obesity and to estimate relative risk for
This present analysis is not limited to any single disease compared to normal weight.1 The NIH
surgical procedure, but, rather, it covers those pro- adopted a classification system of overweight and
cedures described as restrictive or as a combination
of restrictive and malabsorptive. In the present arti- Table 1. NIH and ASBS Classification of Obesity
cle, bariatric procedures were divided into groups
NIHa ASBS b
depending on the mechanism by which weight loss BMI Classification BMI Classification
is promoted. Restrictive surgical procedures (kg/m2) (kg/m2)
decrease the capacity of the stomach, thereby lim- <18.5 Underweight
18.5-24.9 Normal <25 Normal
iting the volume of food consumed before the feel- 25.0-29.9 Overweight 25-<27 Overweight
ing of satiety occurs. Gastroplasty, including verti- 27-<30 Mild obesity
cal banded gastroplasty (VBG) and silastic ring 30.0-34.9 Obesity 30-<35 Moderate
(Class I) obesity
vertical gastroplasty (SRVG) and gastric banding 35.0-39.9 Obesity 35-<40 Severe obesity
procedures such as adjustable silicone gastric (Class II)
banding (ASGB) are examples of restrictive proce- ³40 Extreme obesity >40 Morbid obesity
(Class III)
dures. Combination surgical procedures are those >50 Super obesity
that bypass part of the digestive tract, usually with a
Adapted from “Clinical Guidelines on the Identification, Evaluation, and
a decrease in stomach capacity. Such procedures Treatment of Overweight and Obesity in Adults.”1
combine malabsorption and diminished stomach bAdapted from “Guidelines for Reporting Results in Bariatric Surgery”6

392 Obesity Surgery, 10, 2000


Meta-Analysis of Bariatric Surgery
obesity based on BMI (Table 1). The basis for this Table 2. Summary of search strategies
BMI classification scheme stems from observa- Databases searched:
tional and epidemiological studies that relate BMI The Cochrane Database of Systemic Reviews (through
to risk of morbidity and mortality.1 1999 Issue 2)
The Cochrane Registry of Clinical Trials (through 1999
In 1997, the Standards Committee of the Issue 2)
American Society for Bariatric Surgery (ASBS) The Cochrane Review Methodology Database (through
adopted a classification of obesity, based on BMI 1999 Issue 2)
Combined Health Information Database (CHID) (through
(Table 1). The NIH and ASBS standards are simi- November 30, 1998)
lar, the primary exception being that the NIH terms CRISP (through April 1999)
those individuals with a BMI of 30 kg/m2 or more Current Contents (through April 1999)
The Database of Reviews of Effectiveness (Cochrane
as obese, whereas the ASBS standards classify Library) (through 1999 Issue 2)
those individuals with a BMI of 27 to <30 kg/m2 as DIRLINE (through December 1998)
mildly obese. For the purposes of this article, the ECRI Library Catalog (through April 1999)
terms extreme obesity, morbid obesity, and severe- EMBASE (Excerpta Medica) (1975 through April 16, 1999)
HCFA CD-ROM (Health Care Financing Administration)
ly obese are used interchangeably. The different (through March 1999)
definitions do not affect the analysis in this article. HCFA Web site (Health Care Financing Administration)
All of the studies retrieved for analysis, except for (through March 1999)
Health Devices Alerts (1977 through April 1999)
one, included patients with a mean preoperative Healthcare Standards (1975 through April 1999)
BMI ³40 kg/m2. Health Devices Sourcebase (through April 1999)
HealthSTAR (Health Services, Technology, Administration,
and Research) (1975 through May 10, 1999)
HSRProj (through May 10, 1999)
International Health Technology Assessment (IHTA) (1990
Materials and Methods through April 1999)
Medline (1965 through April 16, 1999)
National Guideline Clearinghouse (through 1999)
Literature Searches. To prepare this article, we Nursing and Allied Health (NAHL/CINAHL) (1982 through
conducted a systematic and comprehensive search November 3, 1998)
for information that involved consulting a number PsycINFO (1980 through December 3, 1998)
TARGET (Technology Assessment Research Guide for
of databases (Table 2). In addition, other mecha- Emerging Technologies) (through April 1999)
nisms were used to retrieve additional relevant infor-
mation, including review of bibliographies/refer- The search strategies employed a number of freetext key-
words as well as controlled vocabulary terms including (but
ence lists from peer-reviewed and gray literature. not limited to) the following concepts:
(Gray literature includes reports, studies, etc., pro- Controlled Trials: Randomized controlled trials; controlled
duced by local government agencies, private organi- clinical trials; meta-analysis; random allocation; single-blind
method; double-blind method, evidence-based medicine
zations, educational facilities, corporations, etc., Gastric Surgery: Gastric bypass; gastroplasty; biliopancre-
which do not appear in the peer-reviewed literature.) atic diversion; Roux-en-Y anastomosis; vertical banding;
Inclusion/Exclusion Criteria. We included in our jejunoileal bypass; obesity/surgery; surgical stapling; stom-
analysis all articles published in English during the ach/surgery; gastric banding; stomach bypass; gastroje-
junostomy; silastic bands
last 5 years. This 5-year period was chosen so that Weight: Obesity; morbid obesity; diabetic obesity; weight
the analysis would de-emphasize those bariatric reduction; weight loss; weight control; appetite depressants;
procedures (such as jejunoileal bypass) that are no diet, reducing; anti-obesity agents; obesity/therapy
Miscellaneous: Quality of life; QOL; comorbidity; social
longer widely performed. For one bariatric proce- adjustment; patients/psychology; activities of daily living;
dure, silastic ring vertical gastroplasty, for which epidemiology; prevalence; statistics; data; demographics;
there is relatively little information, older articles population; prediction
Co-morbidities: dyslipidemia; hyperlipidemia; lipoproteins;
were considered. All randomized controlled trials lipoproteins, HDL; lipoproteins, LDL; triglycerides; choles-
were included, regardless of their publication date. terol; diabetes mellitus, non-insulin-dependent; NIDDM;
Case reports were not included. Case series and all type II diabetes; blood pressure, high; hypertension; sleep
apnea syndromes
forms of controlled trials with ³10 patients that
Exclusions: wasting syndrome; cachexia; obesity/dt In
reported patient weight before and after surgery general, the searches were restricted to human. Case
were included. Case reports and case series with reports were excluded.

Obesity Surgery, 10, 2000 393


Monteforte and Turkelson
fewer than 10 patients were not included, because from contemporaneous, separate groups. Some cau-
the generalizability of their results, given the possi- tion is required in interpreting the results of meta-
bility of unique patients and/or methods, is ques- analyses, because these statistical techniques are not
tionable. Articles that did not specify the type of well studied.
bariatric procedure and articles that co-mingled We performed separate meta-analyses using out-
data for more than one bariatric procedure were not comes reported at 12-months and those reported at
included. In order to avoid double counting, when each study’s longest follow-up duration. Twelve-
articles presented data from the same patients in month outcome data were used because this was
more than one publication, we used only the data the most frequently reported duration of follow-up
from the largest and most recent report. among the studies that met our inclusion criteria.
We included only articles that expressed their To ensure that the results of each study were
results as (or that contained enough information to expressed in accordance with the intent-to-treat
allow us to calculate) BMI. Use of BMI is consis- principle, data from studies that were unable to fol-
tent with suggestions in the “Guidelines for low all of their patients to the completion of the
Reporting Results in Bariatric Surgery” issued by study were analyzed in two ways. First, we
the Standards Committee of the ASBS in 1997.6 assumed that the post-operative mean and standard
When a study reported outcomes in terms of BMI deviation of the BMIs of any study’s patients who
and percentage of ideal body weight, only the BMI were not followed to completion equaled the pre-
results were used in our analysis. This avoids “dou- operative mean and standard deviation of all
ble counting” of studies and allows for expression patients. This assumption is likely to be conservative
of results in terms of BMI wherever possible. because it is tantamount to assuming that, on aver-
Meta-Analytic Methods. For meta-analysis of the age, surgery was unsuccessful in all patients not fol-
effects of bariatric surgery on weight loss, we lowed to a study’s completion. Secondly, we
employed the methods described by Hedges and assumed that the pre-operative mean and standard
Olkin (fixed effects and random effects models) and deviation of the BMIs of any study’s patients who
meta-analyses of data in their original metric were not followed to completion equaled the mean
(BMI).7,8 Because our analysis was on studies that postoperative BMI of patients who were followed to
reported pre- and post-surgery data, and because sta- study completion. This assumption is likely to be
tistical techniques for meta-analysis of such “repeat- anti-conservative because it is tantamount to assum-
ed measures” data are not well studied, we treated ing that, on average, surgery was successful in all
each study’s pre- and post-surgical data as if they patients who were not followed to the end of the
were obtained from a contemporaneous control and study. Thus, our two assumptions to counteract the
experimental group. This means that our analysis is inability to follow all patients to study completion
somewhat conservative (i.e., it underestimates the yield meta-analyses providing results that likely
true degree of weight loss that follows bariatric bracket the true effectiveness of bariatric surgery.
surgery). Another consequence of the meta-analytic Treating pre- and post-surgical data as if they
technique that we employed is that studies needed to were obtained from separate groups of patients can
report pre- and post-operative measures of weight result in violation of the statistical assumptions
along with some corresponding measure of disper- underlying the meta-analytic methods we
sion (or provide us with sufficient data to calculate employed. Further, because the only controlled
these quantities to be included in the analysis). studies on bariatric surgery are studies that mea-
In order to help better understand the magnitude sured patient outcomes before and after surgery (as
of the effect sizes obtained from meta-analyses opposed to controlled trials with contemporaneous
using the Hedges and Olkin methods, we also con- groups), the reporting in the surgical literature
ducted meta-analyses of data in their original metric could give rise to information loss. This informa-
(in this case, meta-analysis conducted in the original tion loss arises because currently available studies
metric results, in effect sizes in BMI units). As do not explicitly examine whether patients respond
above, pre- and post-surgical data reported by any differently to bariatric surgery. For example, it is
given study were treated as if they were obtained entirely possible that, within the time-frame of any

394 Obesity Surgery, 10, 2000


Meta-Analysis of Bariatric Surgery
given study, patients with less favorable BMIs adding variables when the p-value for the coeffi-
experience greater benefit than do patients with cient of the added variable was not significantly
more favorable BMIs. When differential responses related to the predicted variable.
to surgery occur, the average treatment effect does
not describe the response of all patients to treat-
ment. In many (but not all) cases, a differential
response to treatment will cause the variance around Results
the pre-treatment mean to be significantly different
from the variance around the post-treatment mean. Using the above inclusion/exclusion criteria, 62 arti-
For example, a significantly larger post-treatment cles were identified, including 14 randomized con-
variance indicates some patients showed a substan- trolled trials (RCTs). All of these RCTs compared
tial change (i.e., weight loss) while another subset of one treatment to another, and none employed an
patients showed little or no change (or even gained unoperated control group. For these trials, we con-
weight). We therefore tested whether the variances structed a synthetic control group according to the
around the pre- and post-surgical means were differ- two assumptions described in Methods. Twenty of
ent using Bartlett’s test for heterogeneity of vari- these 62 articles reported BMI and contained suffi-
ance.9 We stress that because this test would not cient information to be considered for meta-analysis
detect all differential responses to treatment, the (Table 3; a list of studies that did not contain suffi-
presence of statistically significant heterogeneity of cient information for meta-analysis is available from
variance can be taken to indicate the presence of dif- the authors upon request).
ferential responses, but the absence of such statisti- Of the 20 studies reporting BMI, 11 were unable to
cal significance cannot be taken as proof that no follow all of their patients for the full study (study
such differential responses occurred. length ranged from 3 months to a mean of 98.9
When performing a meta-analysis, it is important months). Eight of the 14 studies reporting 12-month
to test for the presence of statistically significant follow-up data did not follow all patients for the
differences among the results of the studies in the entire 12-month follow-up period. For these studies,
analysis and, if such differences are found, to the percentage of patients lost to follow-up ranged
determine the cause of that heterogeneity. To test from 13% to 99%.
for among-study heterogeneity, we employed two Meta-analyses were conducted for studies with
statistics, the Q-statistic and a test of each study’s complete 12-month and latest follow-up data
standardized residual (both tests are described by (Figure 1 and Figure 2). The Q-statistic for hetero-
Hedges and Olkin.7,8 To determine the cause of het- geneity was statistically significant for both the lat-
erogeneity, we employed stepwise multiple meta- est follow-up data and the 12-month follow-up data.
regression. Regression analyses were conducted Thus, some studies had significantly different results
for both assumptions regarding “missing” patients from others, so that the average result of all the stud-
(i.e., patients who were not followed to study com- ies is not a particularly meaningful description of the
pletion) and for both the latest follow-up and 12- efficacy of any individual technique.
month follow-up data. The variables included in The standard residuals (described above) were
the regression analysis were percentage of patients used to identify studies that were outliers. Applying
lost to follow-up, type of surgery (i.e., restrictive or the method of standardized residuals to those stud-
combination), preoperative BMI, length of follow- ies included in meta-analysis of the latest and 12-
up (except for 12-month outcome data), and publi- month follow-up data identified three outliers
cation year. Ratio of female to male patients and (Figure 1) and two outliers (Figure 2), respectively.
average age of patients were also considered but Bartlett’s test for heterogeneity was statistically
were not included, because this information was significant for two10,11 of the three outliers by
not available for all studies. Variables were added meta-analysis of latest follow-up data and one10 of
in a stepwise fashion in order of their z-scores (data two outliers by meta-analysis of 12-month follow-
available upon request). The variables with the up data. A statistically significant Bartlett’s test
highest z-scores were added first. We stopped suggests the presence of within study variance (i.e.,

Obesity Surgery, 10, 2000 395


Monteforte and Turkelson
Table 3. Studies considered for meta-analysis

Author Intervention Author Intervention


Zorrilla et al., 199921 VBG-GBPa Hsu et al., 199711 RYGBP
VBG-GBPb
Ballesta-Lopez et al., 199822 Laparoscopic Taskin et al., 199723 VBG
NAGB ASGB
Cowan and RYGBP-E Capella and Capella, 199624 VBG
Buffington, 199816 (Females) VBG-RYGBP
(Males)
Karayiannakis et al., 199810 VBG Ryden et al., 199619 VBG
(Successes) c
VBG
(Failures)c
Melissas et al., 199825 VBG Busetto et al., 199518 ASGB
Sapala et al., 199812 NTGBP Kolanowski, 199514 VBG
Seymour et al., 199813 VBG Carson et al., 199426 RYGBP
(hypertensive)
RYGBP
(normotensive)
van Gemert et al., 199817 VBG (M)d Letiexhe et al., 199420 SRVG
VBG (D*)d
Freeman et al., 199727 RYGBPe Brolin et al., 199228 RYGBP-1g
RYGBP-Ef RYGBP-2h
Gahtan et al., 199729 VBG Zimmerman et al., 199215 RYGBP
SRVG
ASGB: adjustable silicone gastric banding NTGBP: near total gastric bypass
RYGBP-E: extended Roux-en-Y gastric bypass RYGBP: Roux-en-Y gastric bypass
GBP: gastric bypass SRVG: Silastic ring vertical gastroplasty
NAGB: nonadjustable gastric banding VBG: vertical banded gastroplasty
a
VBG-GBP without interposition of a limb of jejunum between gastric pouch and the excluded stomach
bVBG-GBP with interposition of a limb of jejunum between gastric pouch and the excluded stomach
c
Success: >50% excess body weight loss (EBWL); Failure: <50% EBWL
d
Marlex (Bard, Billerica, MA) band; Dacron (Maedox, Boston, MA) band
e
(45-135 cm Roux limbs)
f
(180-225 cm Roux limbs)
g75 cm of jejunum bypassed
h
150 cm of jejunum bypassed

1.65 (Cowan and Buffington)


2.0.2 (Cowan and Buffington)
3.2 (Karayiannakis et al.)*
3.2 (Karayiannakis
2.08 (Seymour et al.)
2 (van Gemert et al.) et al.)*
Study

Study

2.14 (van Gemert et al.) 1.93 (Sapala et al.)


2.01 (van Gemert et al.) 2.08 (Seymour et al.)
2.6 (Hsu et al.)
2.16 (Ryden et al.) 1.71 (Busetto et al.)
0.97 (Ryden et al) 2.76 (Kolanowski, et al.)*
1.71 (Busetto et al.)
12.93 2.45 (Zimmerman et al.)
2.45 (Zimmer et al.) (Letiexhe et al.) 1.7 (Zimmerman et al.)
1.7 (Zimmerman et al.)
1.88 (Overall d)**
1.82 (Overall d**)
-5 0 5 10 15 20 0 1 2 3 4 5
Hedges’ d Hedges’ d
Figure 1. Meta-analysis of studies with complete latest Figure 2. Meta-analysis of studies with complete 12-
follow-up data. month follow-up data.
*Outlier by method of standardized residuals7 *Outlier by method of standardized residuals7
**Outliers excluded **Outliers excluded
Q-statistic = 7.3 (p = 0.696652); not statistically significant Q-statistic = 2.65 (p = 0.617755); not statistically significant

396 Obesity Surgery, 10, 2000


Meta-Analysis of Bariatric Surgery
that some patients responded to surgery signifi- cant Q-test). Significant heterogeneity was present
cantly differently than other patients), and provides using either method of correcting for missing data
further evidence that inclusion of such studies (previously described).
might lead to erroneous conclusions about effect Stepwise multiple regression was performed in
size. Therefore, outlier studies were excluded from order to try to identify the source of heterogene-
further analysis. ity. Regression analyses were conducted for both
There were no statistically significant differences 12-month and latest follow-up data using either
among the remaining studies that were included in correction for missing data. Significant hetero-
meta-analyses (i.e., the Q-test for heterogeneity was geneity was observed in three of our four multi-
nonsignificant and there were no outliers identified variate models. However, the multiple regression
by their standardized residuals). Meta-analysis of the analysis, in which we assumed that missing data
6 studies reporting latest follow-up data demonstrat- was equal to the pre-treatment mean appeared to
ed an overall effect size (i.e., overall d) with 95% leave no statistically significant amount of unac-
confidence interval of 1.82 (1.63-2.02) (Figure 1). counted-for variance. Unfortunately, the percent-
Meta-analysis of the four studies reporting 12-month age of patients lost to follow-up was a significant
follow-up data demonstrated an overall effect size predictor of outcome in this model, which could
(i.e., overall d) with 95% confidence interval of 1.88 indicate that our assumption created an artifact.
(1.68-2.07) (Figure 2). Therefore, we considered this model unreliable
The results of meta-analyses conducted in the and conducted meta-analyses that were limited to
original metric are shown in Figure 3 and Figure 4. only studies that reported complete follow-up.
Meta-analysis of latest follow-up data demonstrat-
ed an overall effect size (i.e., BMI reduction) with
95% confidence interval of 13.3 kg/m2 (12.1-14.6
kg/m2). Meta-analysis of 12-month follow-up data Discussion
demonstrated an overall BMI reduction of 16.4
kg/m2 (15.0-17.7 kg/m2). The goal of the present article was to examine the
The results of these meta-analyses are from stud- effects of bariatric surgery on reduction in BMI in
ies that were able to follow all of their patients for morbidly obese persons and to determine whether
the entire study length. When we attempted to weight reduction results in clinically significant
include all studies in meta-analysis, there was a improvements in obesity-related comorbidities.
significant amount of heterogeneity (i.e., a signifi- Meta-analyses were conducted for studies of

13 (Cowan and Buffington)


17.2 (Cowan and Buffington)
21 (Karayiannakis et al.)*
12.8 (Seymour et al.)
13 (van Gemert et
16.7 (van Gemert et al.)
Study

15 (van Gemert et al.)


18.9 (Hsu et al.)
11.5 (Ryden et al.)
4 (Ryden et al.)
12.4 (Busetto et al.)
11.4 (Letiexhe et al.)
15.8 (Zimmerman et al.)
14 (Zimmerman et al.)

13.3 (Overall effect size)**

0 5 10 15 20 25 30
Effect Size (BMI units)

Figure 3. Meta-analysis of latest follow-up data (original metric).


*Outlier by method of standardized residuals7
**Outliers excluded
Q-statistic = 5.48 (p = 0.704982); not statistically significant

Obesity Surgery, 10, 2000 397


Monteforte and Turkelson
NIH classification of overweight and obesity, this
21 (Karayiannakis et al.) weight loss translates to a decrease from obesity
17.4 Sapala et al.) class III (BMI ³40 kg/m2) to overweight (BMI
12.8 (Seymour et al.)
25.0-29.9 kg/m2), obesity class I (BMI 30.0-34.9
12.4 (Busetto et al.)*
Study

16.04 (Kolanowski et al.) kg/m2), or obesity class II (BMI 35.0-39.9 kg/m2).


15.8 (Zimmerman et al.) Although these results are based upon a relative-
14 (Zimmerman et al.) ly small number of studies, they are based on stud-
16.4 (Overall effect size)** ies that contained the most completely reported
0 5 10 15 20 25 30 information with the highest percentage of follow-
Effect Size (BMI units) up. As such, these estimates may underestimate
Figure 4. Meta-analysis of 12-month follow-up data effect size, because, for statistical reasons, the
(original metric). analysis does not contain some of the studies that
*Outlier by method of standardized residuals7 reported more favorable results. It may be possible
**Outliers excluded
Q-statistic = 3.97 (p = 0.410080); not statistically significant that some (but not necessarily all) patients actually
lose more weight (i.e., have lower BMI scores)
bariatric surgery that reported BMI and had com- after bariatric surgery.
plete patient follow-up. From the results of meta- These findings also suggest that the initial reduc-
analysis (conducted in their original metric), the tion in BMI (as measured by 12-month results)
following conclusions can be made. Based upon might be greater than BMI achieved when patients
the four studies12-15 reporting BMI results with are followed for longer periods of time. This would
complete 12-month follow-up, morbidly obese be consistent with the findings of the 1991 NIH con-
patients had an overall reduction in BMI of 16.4 sensus development conference on gastrointestinal
kg/m2. Based upon the six studies with complete surgery for severe obesity.4 This conference noted
follow-up for the final reported BMI,13,15-19 mor- that substantial weight loss generally occurs, with
bidly obese patients had an overall reduction in the weight nadir occurring in 18 to 24 months.4 The
BMI of 13.3 kg/m2. Mean duration of follow-up for committee also noted that some regain of weight is
the six studies included in the latter meta-analysis common by 2 to 5 years after operation.
ranged from 9 months to 7 years. In 1997, the Standards Committee of the
For patients included in the meta-analysis, this American Society for Bariatric Surgery recom-
weight reduction resulted in post-operative BMIs mended that ideal long-term follow-up for weight
ranging from 30 to 34.1 kg/m2 at 1 year and 27.7 to loss should be 5 years or longer and discouraged
39.0 kg/m2 at latest follow-up. According to the reporting weight loss with less than 2 years of fol-

Table 4. Summary of reported complicationsa by procedure type


Complication Restrictive Procedures (n = 3,568) Combination Procedures (n = 3,626)
Perioperative Deaths 5 (0.14%) 14 (0.39%)
(£ 30 days of surgery)
Bleeding 16 (0.45%) 32 (0.88%)
Dumping Syndrome 10 (0.28%) 531 (14.64%)
Infection 111 (3.11%) 191 (5.27%)
Splenic Injury 8 (0.22%) 29 (0.8%)
Stomal Stenosis/
Gastric Outlet Obstruction 79 (2.21%) 97 (2.68%)
Gastric Pouch/Stoma
Dilation 86 (2.41%) 17 (0.47%)
Staple-Line Failure 55 (1.54%) 216 (5.96%)
Stomach Erosion/
Ulceration 43 (1.21%)* 42 (1.16%)*
*20 (0.56%) of these were band erosions **2 (0.06%) of these were band erosions
Vitamin/Mineral 58 (1.63%) 398 (10.98%)
Deficiency
Vomiting 303 (8.49%) 93 (2.56%)
aComplications reported as number and percentage of patients.

398 Obesity Surgery, 10, 2000


Meta-Analysis of Bariatric Surgery

low-up.6 Duration of follow-up was 12 months or some patients may have experienced more than one
less in four of the six studies included in meta- complication while other patients may have experi-
analysis.13,15,16,18 Therefore, overall reduction in enced none. It should also be noted that the report-
BMI reflected by these studies may underestimate ed outcomes might underestimate the actual num-
maximum weight-loss potential for these patients. ber of complications because complications were
Furthermore, this overall reduction in BMI may either not provided by a particular study or a par-
not reflect the final BMI if this group of patients ticular complication may not have been reported.
were followed for longer periods of time. Because it is not clear whether there is complete
Although we included studies that used a variety reporting of complications in the literature, we did
of surgical procedures in our meta-analysis, our not attempt to compare complication rates among
results suggest that there is little difference in effi- the different surgical procedures.
cacy among these procedures. Among the six stud- Morbid obesity is accompanied by a reduction in
ies included in the meta-analysis, five different sur- life expectancy, which is due in large part to signifi-
gical procedures were represented: three restrictive cant comorbid associations in the form of metabolic
procedures (ASGB, SRVG, and VBG) and two abnormalities and several severe cardiopulmonary
combination procedures (RYGBP and RYGBP-E). disorders.4 In addition, significant psychosocial and
As such, it is difficult to draw conclusions about economic problems are frequently experienced by
either type of surgery or about any particular persons with severe (morbid) obesity.4
bariatric procedure. However, the lack of a signifi- Evidence of the effect that weight loss following
cant Q-test for heterogeneity or any outliers suggests bariatric surgery has on various comorbid condi-
that, within this data set, there is no difference tions stems largely from case series reports. One of
between procedures. Stated another way, there were the key problems in evaluating reports of case
no significant differences in effect size resulting series in surgical therapy is the lack of standards
from any of the five different bariatric operations for comparison.4 The practice of comparing post-
included in the meta-analysis. However, more stud- operative indicators of comorbidity to the same
ies are needed to determine whether any clinically patient’s own pre-operative status is insufficient for
meaningful difference among operations exists. evaluation of long-term effects and of survival.4
In order to ascertain whether the results of stud- The difficulty in evaluating the effects of weight
ies included in meta-analysis are representative, we loss on various obesity-related comorbidities is
performed a regression analysis of change in BMI compounded by the lack of complete follow-up.
as a function of initial BMI for both included and Twenty of the 62 studies that met the initial criteria
non-included studies. Regression analysis demon- for inclusion in the present article provided com-
strated that the relationship between initial BMI plete follow-up data. Of these 20 studies, only
and change in BMI is linear (i.e., greater reductions three studies reported the effects of weight loss fol-
in BMI were observed for patients with a greater lowing bariatric surgery on one or more obesity-
initial BMI). The correlation (r2) between initial related comorbidities.10,16,20 Therefore, a quantita-
BMI and change in BMI for included studies was tive analysis of this data was not performed.
0.58. The correlation (r2) between initial BMI and To ascertain the impact of BMI on mortality and
change in BMI for non-included studies was 0.25 to determine the effects of weight loss on several
(difference not statistically significant). major obesity-related comorbidities, other evi-
There have been a number of reported complica- dence-based sources were consulted. The magni-
tions associated with bariatric surgery (Table 4). In tude of weight loss following bariatric surgery, as
the present article, complications reported by the determined through meta-analysis, was used to
62 studies that met initial inclusion criteria were examine whether such weight loss is clinically
totaled and grouped by surgery category (i.e., meaningful.
restrictive vs. combination procedures). The total The relationship between BMI and mortality was
number of complications reported by each study recently described by the American Cancer
were tabulated as opposed to the number of Society.3 In this large, prospective study, the lowest
patients who developed complications. Therefore, rates of death from all causes were found at BMIs

Obesity Surgery, 10, 2000 399


Monteforte and Turkelson

between 22.0 kg/m2 and 23.4 kg/m2 in women and 1994), the average height for men and women more
23.5 kg/m2 and 24.9 kg/m2 in men.3 Among healthy than 20 years of age is 1.68 and 1.62 m, respective-
patients who had never smoked, the relative risk for ly.2 Applying the 13.3 to kg/m2 reduction in BMI to
all-cause mortality increased with BMI levels of this population translates to a weight reduction of
approximately 30 kg/m2 or more. The reported rela- 37.5 kg for men and 34.9 kg for women.
tive risks of death from all causes among adults (age Based on the findings of the NIH report (Table
30-64 years) are listed in Table 5. 6), weight reduction following bariatric surgery in
Data regarding the effect of weight loss on major morbidly obese patients may be associated with
obesity-related comorbidities were derived from the improvements in risk factors associated with cardiac
1998 NIH “Clinical Guidelines on the Identification, disease, including hypertension, type 2 diabetes, and
Evaluation, and Treatment of Overweight and lipid abnormalities. For patients with obstructive
Obesity in Adults”.1 This evidence-based report sys- sleep apnea, weight reduction may result in decreas-
tematically reviewed the relevant published scientif- ing the severity of this condition. Because weight
ic literature. The available evidence was derived reduction following bariatric surgery is greater than
largely from randomized controlled trials that exam- the weight loss reported by studies included in the
ined the impact of weight loss achieved through NIH report, significant improvements in these
nonsurgical measures. The findings of the NIH comorbidities are expected. However, the magnitude
report are summarized in Table 6. of these improvements can only be inferred.
The mean pre-operative BMI for those patients Likewise, it appears that reduction in BMI following
from the six studies included in meta-analysis of bariatric surgery would decrease patients’ relative
latest outcome data ranged from 41 kg/m2 to 52.3 risk for all-cause mortality.
kg/m2. Meta-analysis of these studies demonstrat- Further research is needed to examine the long-
ed a 13.3 kg/m2 reduction in BMI. Applying this term benefits of bariatric surgery, particularly with
BMI reduction to this group of patients would respect to obesity-related comorbidities. Research
result in post-operative BMIs ranging from 27.7 to in this area might consist of RCTs that compare the
39 kg/m2 (25%-32% reduction). levels of morbidity and mortality for patients who
According to prevalence data from the National receive surgery to those of patients who do not.
Health and Nutrition Survey (NHANES III, 1988 to Additional research comparing the various surgical

Table 5. Reported relative-risks of death from all causes among obese adults (age 30-64 years)
BMI (kg/m2)
Men
30.0-31.9 32.0-34.9 >35
Relative risk (95% confidence interval) 1.62 2.05 2.30
(1.34-1.97) (1.66-2.53) (1.72-3.06)
Women
30.0-31.9 32.0-34.9 35.0-39.9 ³40
Relative risk (95% confidence interval) 1.51 1.53 1.86 2.70
(1.28-1.79) (1.27-1.84) (1.51-2.30) (2.03-3.60)

Data from Calle et al.3

Table 6. Changes in comorbidity associated with weight reductiona


Comorbidity Weight Reduction Associated Change in Comorbidity
Hypertension 10 kg Systolic blood pressure: -7 mm Hg
Diastolic blood pressure: -3 mm Hg
Type 2 diabetes 2.4 to 5 kg HbA1c: -2% to -2.4%
Lipids 5% to 13% Cholesterol: 0% to -18%
Triglycerides: -2% to -44%
LDL cholesterol: -3% to -22%
HDL cholesterol: -7% to 22%
Obstructive sleep apnea 10% 50% reduction in severity
aSource: NIH, “Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.”1

400 Obesity Surgery, 10, 2000


Meta-Analysis of Bariatric Surgery
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