Laporan Kasus

J Indon Med Assoc, Volum: 62, Nomor: 3, Maret 2012 107

Mortality and Morbidity Benefit of
Bariatric Surgery Among Obese Patients:
an Evidence Based Report
Alvin Nursalim,* Wismandari Wisnu**
*Faculty of Medicine Universitas Indonesia, Jakarta
**Department of Internal Medicine Metabolic Endocrine Division,
Faculty of Medicine Universitas Indonesia-Cipto Mangunkusumo Hospital, Jakarta
Abstract
Introduction: Bariatric surgery is a surgical procedure resulting in weight loss. Weight loss
after surgery is well documented, but the favorable effect on mortality and morbidity need to be
further elucidated.
Aim: To determine whether bariatric surgery possess mortality and morbidity benefit.
Method: After structured literature searching, all studies are critically appraised and presented
as evidence based case report.
Result: All five studies are considered to have good validity and relevance. Sjostorm et al and
Adams et al confirmed reduction of mortality in surgery group. Relative risk reduction (RRR):
21% and 31%, absolute risk reduction (ARR): 1.3% and 1.4%, number needed to treat (NTT):
77 and 72. Incidence of diabetes, hypertryglyceride and hyperuricemia were significantly lower
in surgery group after 10 years (RRR 6-20%, ARR 5-10% and NNT 10- 20).
Conclusion: Bariatric surgery for severe obesity is associated with decreased mortality and
morbidity. J Indon Med Assoc. 2012;62:107-12.
Keywords: Obesity, bariatric surgery, mortality, morbidity
Korespondensi: Alvin Nursalim, Email: alvin.nursalim@yahoo.com
J Indon Med Assoc, Volum: 62, Nomor: 3, Maret 2012 108
Operasi Bariatrik dalam Menurunkan Mortalitas dan Morbiditas pada
Pasien Obes: Laporan Berbasis Bukti
Alvin Nursalim*, Wismandari Wisnu**
*Fakultas Kedokteran Universitas Indonesia, Jakarta
**Departemen Ilmu Penyakit Dalam Divisi Metabolik Endokrin Fakultas Kedokteran Universitas Indonesia/
Rumah Sakit Cipto Mangunkusuno, Jakarta
Abstrak
Pendahuluan: Operasi bariatrik adalah prosedur yang bertujuan untuk menurunkan berat
badan. Penurunan berat badan setelah prosedur ini banyak didokumentasikan, namun keuntungan
bedah bariatrik terhadap mortalitas dan morbiditas masih perlu dipelajari lebih lanjut.
Tujuan: Untuk mengetahui efek operasi bariatrik terhadap mortalitas dan morbiditas pada
individu obes.
Metode: Setelah dilakukan pencarian literatur secara terstruktur, studi yang didapat ditelaah
kritis dan disajikan dalam bentuk laporan berbasis bukti.
Hasil: Ditemukan lima studi dengan validitas dan relevansi yang baik. Sjostorm et al dan Adams
et al memaparkan penurunan angka mortalitas pada kelompok operasi bariatrik. Hal ini terlihat
dari relative risk reduction (RRR) 21% dan 31%, absolute risk reduction (ARR) 1,3% dan 1,4%,
serta number needed to treat (NTT) 77 dan 72. Operasi bariatrik menyebabkan penurunan
insiden diabetes, hipertrigliserida dan hiperurisemia setelah 10 tahun (RRR: 6-20%, ARR:5-
10% dan NNT:10-20).
Kesimpulan: Operasi bariatrik pada individu obes berhubungan dengan menurunnya mortalitas
dan morbiditas. J Indon Med Assoc. 2012;62:107-12.
Kata Kunci: Obesitas, operasi bariatrik, mortalitas, morbiditas.
Introduction
Obesity is defined by a body mass index (BMI) of 30 or
more. The BMI cut-off for obesity varied among region, BMI
above 25.0 is considered obese for Asia Pacific population.
1,2
The amount of obesity cases around the world is stagger-
ing. There are approximately 250 million people with BMI
>30 kg/m
2
worldwide. This number represents 7% of adult
population.
2
According to Riset Kesehatan Dasar 2010,
the prevalence of obesity for individual above 18 years old
is 21.7%. This number is higher as compared to obesity preva-
lence in 2007 (19.1%). We can expect an even higher obesity
cases in the upcoming years. As obesity cases increase, the
complications would eventually rise as well.
3
The increasing
number of obesity is very much influenced by the
obesogenic environment that promote sedentary lifestyle
and attractive calorie-riched food (usulally called as junk
food).
4
Obesity is strongly linked to the increasing amount of
cardiovascular complication. Obesity increases triglyceride
level, which has a detrimental effect on cardiac health. On
the other hand, obesity reduce the amount of cardiac-pro-
tective lipid, high density lipoprotein (HDL).
5
As obesity case
increase, the amount of hypertension case would also in-
crease accordingly. Obesity is also associated with other
numerous comorbidities, such as diabetes mellitus, left ven-
tricular hypertrophy, certain cancers, and sleep apnea or
sleep-disordered breathing.
6
Weight loss is known to be associated with improve-
ment of risk factors for many diseases, including diabetes,
hypertension, and dyslipidemia; therefore, lifestyle changes
and medication need to be applied to those obese popula-
tion. Despite intensive lifestyle changes and maximum medi-
cation regimens, some people failed to achieve the target
ideal weight. In this case, more aggressive measure need to
be done, especially in those population with BMI >35 kg/m
2
with comorbid or BMI >40 kg/m
2
. Bariatric surgery might be
the only hope for those markly obese population who unre-
sponsive to other treatment.
4
Bariatric surgery is a surgical procedures designed to
produce substantial weight loss. There are various bariatric
procedures, such as: laparoscopic adjustable gastric bands
and vertical banded gastroplasty; a restrictive but also
malabsorptive concept such as roux-en Y gastric bypass and
sleeve gastrectomy.
4
Since bariatric surgery is the last
meassure for obesity and rarely performed, especially in In-
donesia, not many clinician are aware of this procedure. Al-
though bariatric surgery is not as popular in Indonesia as it
Mortality and Morbidity Benefit of Bariatric Surgery Among Obese Patients
Mortality and Morbidity Benefit of Bariatric Surgery Among Obese Patients
J Indon Med Assoc, Volum: 62, Nomor: 3, Maret 2012 109
is in western countries, but as more evidence support the
efficacy of this surgery for severe obese population, it is
noteworthy for clinician to know about the surgery. Hope-
fully, this report could give a new insight on bariatric sur-
gery for obesity management in Indonesia.
Weight loss after the surgery is well documented, but
information regarding the favorable effect of the surgery on
life span and morbidity is lacking; therefore whether bariatric
surgery possess benefit in terms of mortality and morbidity
need to be investigated.
Clinical Question
Does bariatric surgery provide benefit on mortality and
morbidity for obese population who underwent the proce-
dure?
According to International Diabetes Federation, the
recommended BMI for bariatric surgery is BMI >35 kg/m
2
with comorbid or BMI >40 kg/m
2
. However, to expand our
discussion later on and to give further recommendation, we
did not limit our search to a certain grade of obesity.
1
So, if
any, even first grade obesity (defined by BMI >30 kg/m
2
and
BMI >27.5 kg/m
2
for asian) would be included in the ap-
praisal.
From the clinical question above, the intervention is
any bariatric surgery procedure, while the comparison is any
lifestyle and medication intervention (excluding any surgery
intervention) that usually performed among obese popula-
tion. Mortality benefit is defined by any death reduction
from any cause during follow-up period, which benefit most
likely to occur in long term (although we are not excluding
any immediate mortality benefit, if there is any at all). Mor-
bidity is defined the state of being unhealthy. There are nu-
merous parameters for morbidity, such as disease remission
(good blood glucose control on diabetes, dyslipidemia) and
quality of life.
Method
PubMed and Google search was performed on
March 7
th
2012, using the keywords obese, bariatric,
mortality, and morbidity along with its synonyms and
related terms (Table 1). Search strategy, results, the inclusion
and exclusion criterias are shown in a flowchart (Figure 1).
Bariatric surgery is a relatively new procedure to treat obe-
sity; therefore, we deliberately limit our search to any stud-
ies published from 2001 to early 2012. In this review we only
appraise individual study or randomized controlled trial (RCT)
with relevant topic with the clinical question. After the selec-
tion, critical appraisal was performed using several aspects
based on Center of Evidence-based Medicine, University of
Oxford for therapy study (Table 2).
8
Table 1. Search Strategy used in PubMed and Google (Con
ducted on March 7
th
2012)
Database Search terms Results
Pubmed ((bariatric surgery[MeSH Terms] OR 44
(7
th
March 2012) (bariatric [All Fields] AND surgery
[All Fields]) OR bariatric surgery
[All Fields]) AND (gastric bypass
[MeSH Terms] OR (gastric
[All Fields] AND bypass[All Fields])
OR gastric bypass[All Fields])
AND (mortality[Subheading] OR
mortality[All Fields] OR mortality
[MeSH Terms]) AND (obesity[MeSH
Terms] OR obesity[All Fields] OR
obese[All Fields])) AND (2007/01/16
[PDat] : 2012/01/14[PDat])
Googl e Bariatric, obese, gastric bypass, mortality, 5
(7
th
March 2012) morbidity
Figure 1 Flow Chart of Search Strategy
Mortality and Morbidity Benefit of Bariatric Surgery Among Obese Patients
J Indon Med Assoc, Volum: 62, Nomor: 3, Maret 2012 110
Result
From the selection and filtration, five articles qualified
for further assessment. These articles were appraised and
considered to have a good validity and relevance. Most of
these studies are large scale studies with adequate follow
up period and all of them are written in english. We did not
find any articles written in other language beside english
that would be otherwise relevant to our clinical question.
Sjostrom et al studied the long term benefit of bariatric
surgery in swedish obese population. The study involved
4047 obese subjects, which comprised of two groups, 2010
subjects in the surgery group, and 2037 subjects in the con-
trol group who only receive conventional treatment (lifestyle
changes) for obesity. Of the 2010 subjects in the surgery
group, 376 underwent nonadjustable banding, 1369 under-
went vertical banded gastroplasty, and 265 underwent gas-
tric bypass. The average BMI for the surgery group was
42.44.5 and for the control group was 40.14.7.
9
The mortality hazard ratio for subject who underwent
the surgery as compared with the control group was 0.76
(95% confidence interval, 0.59 to 0.99; P=0.04). During the
follow-up period, 129 subjects in the control group died, as
compared with 101 in the surgery group. The Control Event
Sjostrom L et al
9
+
4047 - + + + + + + + A 2B
Adams TD et al
10
-
**** 9949 - + ? + + + + + B 2B
Dixon JB et al
11
+
60 + + ? + + + + + C 1B
Sjostrom L et al
12
+
4047 - + ? + + + + + D 2B
Dixon JB et al
13
+
459 ? + ? + + + + + E 1B
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Articles Validity Relevance Resul t Levels of
evidence***
Table 2 Critical Appraisal of the 5 useful articles based on criterias by Centre of Evidence Medicine University of Oxford
8
Legend: + stated clearly in the article
- not being done
? not stated clearly
*Since the intervention is surgical procedure, randomization is not performed in most studies.
**We define blinding for outcome assessor and this blinding need to be clearly stated in the study.
***Levels of evidence based on The Oxford Centre of Evidence-based Medicine
**** The study performed by Adams TD et al was a retrospective cohort study
A: After 10 years, there were 129 deaths in the control group and 101 deaths in the surgery group. The hazard ratio was 0.76 in the surgery
group (95% confidence interval, 0.59 to 0.99; P = 0.04)
B: During a mean follow-up of 7.1 years, long-term mortality from any cause in the surgery group decreased by 40%, as compared with
that in the control group (37.6 vs. 57.1 deaths per 10,000 person-years, P<0.001).
C: Remission of type 2 diabetes was achieved by 22 (73%) in the surgical group and 4 (13%) in control group. Relative risk of remission
for the surgical group was 5.5 (95% confidence interval, 2.2-14.0).
D: The incidence of diabetes, hypertryglyceride and hyperuricemia was significantly lower in the surgery group after 10 years.
E: After a 4 years follow up after the surgery, all quality of life parameters showed a significant improvement (P<0.001), which include:
physical function, pain, and social function.
Rate (CER) was 6.3%, Experimental Event Rate (EER) was
5.0%, Relative Risk Reduction (RRR) was 21%, Absolute Risk
Reduction (ARR) was 1.3% and Number Needed to Treat
(NNT) was 77.
Adams et al performed a retrospective cohort study to
determine the long term mortality among 9949 patients who
underwent gastric bypass surgery. The rate of death from
any cause was 40% lower in the surgery group than in the
control group (hazard ratio, 0.60; 95% confidence interval,
0.45 - 0.67; P<0.001). The value of RRR was 34%, ARR was
1.4%, and NNT was 72. The rate of death due to cardiovas-
cular disease and diabetes was reduced by 49% (P<0.001)
and 92% (P=0.005) respectively. There was an increased risk
of non-disease related death (accident and suicide) by a fac-
tor of 1.58 in the surgery group as compared to control
group.
10
Dixon et al performed a study to determine the efficacy
of laparoscopic adjustable gastric banding (LAGB) in im-
proving glycemic control as compared to conventional
therapy (lifestyle changes and medication) in 60 obese pa-
tients with recently diagnosed type 2 diabetes. The rate of
good glycemic control (this journal used the term remission
of diabetes which was defined by fasting plasma glucose
J Indon Med Assoc, Volum: 62, Nomor: 3, Maret 2012
Mortality and Morbidity Benefit of Bariatric Surgery Among Obese Patients
111
levels <126 mg/dL and HbA1c levels < 6.2% without use of
hypoglicemic agents or insulin) was 73% in the surgery group
and 13% in the control group. The relative risk for surgical
remission: 5.5, 95% confidence interval, 2.2-14; P<0.01.
11
Sjostrom et al performed another analysis on 4047 Swed-
ish obese subjects who underwent bariatric surgery.
12
The
incidence of diabetes, hypertryglyceride, and hyperuricemia
were lower in the surgery group after 10 years. The value of
RRR, ARR, NNT and odds ratios (OR) were as follow: diabe-
tes (RRR: 6%, ARR: 5%, NNT: 20, OR:0.25, 95% confidence
interval, 0.17 to 0.38; P<0.001), hypertryglyceride (RRR: 12%,
ARR: 7%, NNT: 15, OR:0.61, 95% confidence interval, 0.39 to
0.95; P=0.03), and hyperuricemia (RRR: 22%, ARR: 10%, NNT:
10, OR:0.49, 95% confidence interval, 0.34 to 0.71; P<0.001).
There was clearly a significant event reduction in all param-
eters above.
Dixon JB
13
performed a study to determine the improve-
ment of Quality of Life (QOL) in 459 severe obese subjects
before and after bariatric surgery. The instrument being used
for the QOL meassurement was the Medical Outcome Study
Short Form-36 (SF-36). SF-36 health survey has been used
widely; therefore, could provide the most relevant way to
assess the value of QOL. The health survey was scored in a
standard manner into 8 multi item scaled scores, or domains.
The domain scaled scores (0 to 100) are physical function,
physical role, pain, general health, vitality, social function-
ing, emotional role, and mental health. A yearly follow up
until 4 years after the surgery were done, all data were finally
analyzed using a linear regression analysis. After a 4 years
follow up after the surgery, all QOL parameters showed a
significant improvement (P<0.001), which include: physical
function, pain, and social function.
Discussion
Bariatric surgery is more acceptable as obesity treat-
ment these days than it used to be. The more advanced
technique and more studies available regarding the benefit
of this procedure might contribute to the increased demand
of this surgery.
From our extensive reasearch, we found two studies
which correspond to mortality benefit and three studies
which correspond to morbidity benefit of bariatric surgery.
According to Sjostorm et al and Adams et al, extremely obese
subjects who underwent bariatric surgery was proven to
have decreased mortality (relative risk reduction were 21%
and 31%, respectively). One point to note, according to
Adams et al, the increased risk of non-disease related death
might be related to the unrecognized presurgical mood dis-
order or post-traumatic stress; therefore, we recommend psy-
chological guidance pre and post surgery in every patient
who undergo the procedure.
The value of NNT in Sjostorm et al
9
and Adams et al
10
were 77 and 72, respectively. Although the NNTs were high,
since the clinical endpoint is devastating enough (morta-
lity), this procedure may still be indicated in particular situa-
tions; therefore, careful candidate selection is required.
The third study by Dixon et al gave us an insight in
morbidity benefit of bariatric surgery in terms of diabetes
glucose control.
11
Dixon et al conclude that bariatric surgery
was more efficacious as compared to conventional therapy
in diabetes remission (relative risk for diabetes remission I
the surgery group: 5.5, 95% confidence interval, 2.2-14;
P<0.01). Some limitations of this study are the small sample
size (60 patients) and the brief follow up. The greater remis-
sion of diabetes among patients who underwent surgery in
this study might partly explain the reduction of diabetes-
related mortality in the bariatric group from previous study
by Adams et al. But, the direct mechanism as to how the
surgery increases diabetes remission and finally reduces dia-
betes-related mortality need to be further investigated.
Sjostrom et al
12
and Dixon et al
13
also conducted a study
to determine morbidity benefit of bariatric surgery, but with
different parameters. Sjostrom provide another metabolic
benefit of the surgery on a large obese population who un-
derwent bariatric surgery (incidence reduction of diabetes,
hypertryglyceride, and hyperuricemia in the surgery group).
The value of the NNT was quite small for all parameters
mentioned above. This fact showed that bariatric surgery
was an effective meassure to reduce morbidity among se-
vere obese population.
12
Dixon et al conclude that bariatric surgery significantly
resulted in quality of life improvement. The meassurement
being used was a questionnaire/form that could jeopardize
the objectivity of the result. Nevertheless, this form has been
used widely in different population with a broad range of
medical conditions to determine quality of life in so many
countries, so this form is a suitable instrument to meassure
QOL.
13
According to International Diabetes Federation, the cut-
off points should be lowered by 2.5 BMI point levels for
Asians.
4
So, based on this principle, it is logical to start con-
sidering about the procedure for Asian who failed another
treatment with BMI >32.5 kg/m
2
with comorbid (such as dia-
betes) or BMI >37.5 kg/m
2
.
In order to achieve optimal benefit of bariatric surgery,
multiple factors need to be considered cautiously. Study
showed that there was a connection between the experience
of surgeons and complication of bariatric surgery.
10
Another
factor to consider is the long term multidisciplinary approach
pre and post operative, which include: internist, surgeon,
pshychiatrist and nutritionist.
Beside the efficacy of this surgery to reduce mortality,
the application of this procedure in an insurance-based
health care system requires cost-benefit analysis. Accord-
ing to Hoerger et al, bariatric surgery is a cost effective treat-
ment for severe obese population with diabetes. The cost-
effective of bariatric surgery was due to the reduction of all
cost related to obesity and diabetes complications.
14
The
Mortality and Morbidity Benefit of Bariatric Surgery Among Obese Patients
J Indon Med Assoc, Volum: 62, Nomor: 3, Maret 2012 112
risk of complication post-operative, high cost of the surgery
and the high NNT as showed above, made it absurd to apply
this surgery for general obese population; therefor, this sur-
gery required meticulous candidate selection to assure the
safety and long term benefit of the procedure. Limited ac-
cess to multidisciplinary facilities in some Indonesian re-
gion, might also compromise the benefit of this surgery. The
wide variety of bariatric surgery procedures require further
investigation as to determine which one is the best proce-
dure in terms of clinical and cost efficacy.
All these studies are not without limitations. Since the
intervention is an invasive surgical procedure, it would be
unethical to perform randomization. The lack of randomiza-
tion made most of these clinical trials fall into a lesser level of
evidence. Other limitation of this appraisal is the small num-
ber of articles found. We only found one relevant articles
with good level of evidence (1b). Nonetheless, all of these
articles reported similar findings in terms of mortality and
morbidity benefit of bariatric surgery. One important thing to
be further studied is the long term safety profile of this pro-
cedure. Although, most studies showed favourable effect of
bariatric surgery, clinical experience with this type of sur-
gery is still limited (especially in Indonesia) and there might
be other side effects yet to be discovered. Therefore, the
conclusion of these studies need to be applied with caution.
Conclusion
These evidence provides reliable proof of the benefit of
bariatric surgery in terms of hard end point (mortality) and
morbidity for extremely obese patient. From our extensive
searching, there was still limited high-quality studies upon
this matter. So, further studies are required to give clinician
more high-quality evidence (RCT) to back up their clinical
decision. For now, this invasive procedure need to be ap-
plied with caution, require each patients characteristic
assestment and thorough consideration.
Recommendation for clinical use
These evidences can be applied into clinical practise.
For example, this case is presented to us. A 55 years old
woman came to a private hospital for a regular check-up. She
came from a good socio-economic background. She had been
diagnosed of diabetes, hypertension and dyslipidemia since
2 years ago. The doctor concerned about her body weight.
Her weight was 89 kg, while her height was 1.57 m. Her BMI
was 36 kg/m
2
. Her body weight used to be 94 kg and her
body weight remained the same despite maximum diet and
intensive lifestyle changes for the last 8 months. She also
complained of depression and lack of confidence due to her
physical appearance. The doctor considered a bariatric sur-
gery as the last meassure. According to the evidences found,
bariatric surgery is proven to have beneficial effect in terms
of diabetes remission and reduced overall mortality. Bariatric
surgery can be carried out for this case. We emphazise on
the long term multidisciplinary approach pre and post opera-
tive. Patient physical and mental condition need to be sup-
ported throughout the procedure.
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BEP