extended clavien-dindo classification of surgical ......ple, intra-abdominal abscess, pyothorax,...
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Surg Today (2016) 46:668–685DOI 10.1007/s00595-015-1236-x
1 3
ORIGINAL ARTICLE
Extended Clavien‑Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria
Hiroshi Katayama1 · Yukinori Kurokawa2 · Kenichi Nakamura1 · Hiroyuki Ito3 · Yukihide Kanemitsu4 · Norikazu Masuda5 · Yasuhiro Tsubosa6 · Toyomi Satoh7 · Akira Yokomizo8 · Haruhiko Fukuda1 · Mitsuru Sasako9
Received: 24 April 2015 / Accepted: 14 June 2015 / Published online: 20 August 2015 © The Author(s) 2015. This article is published with open access at Springerlink.com
commonly in their fields and defined more detailed grading criteria for each complication in accordance with the gen-eral grading rules of the Clavien-Dindo classification.Results We listed 72 surgical complications experienced commonly in surgical trials, focusing on 17 gastroentero-logic complications, 13 infectious complications, six tho-racic complications, and several other complications. The grading criteria were defined simply and were optimized for surgical complications.Conclusions The JCOG postoperative complications cri-teria (JCOG PC criteria) aim to standardize the terms used to define adverse events (AEs) and provide detailed grading guidelines based on the Clavien-Dindo classification. We believe that the JCOG PC criteria will allow for more pre-cise comparisons of the frequency of postoperative compli-cations among trials across many different surgical fields.
Keywords JCOG postoperative complications criteria (JCOG PC criteria) · Clavien-Dindo classification · Postoperative complications
Introduction
The evaluation of postoperative complications in surgi-cal trials is as important as the assessment of toxicities in chemotherapy trials. Prior to the proposal of a therapy-ori-ented classification scheme, by Clavien PA et al. in 1992 [1], there were no accepted definitions for the grading of surgical complications in clinical practice. This framework proposed by Clavien et al. was not used widely, because there was no system for the grading of severity of surgical complications [2] and no uniform definition of these events. For instance, some surgeons included a body tempera-ture greater than 38 °C on two consecutive days as being
Abstract Purpose Prior to publication of the Clavien-Dindo clas-sification in 2004, there were no grading definitions for surgical complications in either clinical practice or surgical trials. This report establishes supplementary criteria for this classification to standardize the evaluation of postoperative complications in clinical trials.Methods The Japan Clinical Oncology Group (JCOG) commissioned a committee. Members from nine surgi-cal study groups (gastric, esophageal, colorectal, lung, breast, gynecologic, urologic, bone and soft tissue, and brain) specified postoperative complications experienced
* Mitsuru Sasako [email protected]
1 Japan Clinical Oncology Group Data Center/Operations Office, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan
2 Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan
3 Department of Thoracic Surgery, Kanagawa Cancer Center, Yokohama, Japan
4 Colorectal Surgery Division, National Cancer Center Hospital, Tokyo, Japan
5 Department of Surgery, Breast Oncology, National Hospital Organization, Osaka National Hospital, Osaka, Japan
6 Division of Esophageal Surgery, Shizuoka Cancer Center, Shizuoka, Japan
7 Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan
8 Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
9 Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan
669Surg Today (2016) 46:668–685
1 3
“high”, whereas others included intraoperative complica-tions, postoperative complications (within 30 days), and late events such as dumping syndrome. Few randomized controlled trials (RCTs) [3] have used this classification system, with individual parochial definitions of surgical complications being used in most surgical RCTs [4–6].
In cancer clinical trials, adverse events (AEs) are evalu-ated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), which is far from exhaustive in terms of surgical complications; thus, some surgeons are not comfortable using grading definitions. The Clavien-Dindo classification, published in 2004 [7] defined a sim-ple classification of postoperative complications, which has been adopted widely in clinical practice. Although this clas-sification categorizes postoperative complications broadly into four major groups, it is often desirable to more clearly define the common AEs to avoid the use of different or less precise terms for the same AEs occurring in different clini-cal trials. More detailed grading criteria for common AEs would also be helpful for surgeons. Therefore, our aim was to establish supplementary criteria for the Clavien-Dindo classification to standardize the evaluation of postoperative complications.
Methods
The Japan Clinical Oncology Group (JCOG) commis-sioned a committee to establish more precise criteria for the grading of surgical complications. The committee com-prised members from nine JCOG study groups (gastric, esophageal, colorectal, lung, breast, gynecologic, urologic, bone and soft tissue, and brain) who have extensive expe-rience with surgical trials. These groups established the JCOG postoperative complications criteria (JCOG PC cri-teria). Members identified the postoperative complications experienced commonly in their fields and defined detailed grades for each complication in accordance with the gen-eral grading rules of the Clavien-Dindo classification. The JCOG PC criteria were reviewed and approved by the JCOG Executive Committee and published on the JCOG website in October, 2011 (in Japanese) [8].
Results
The JCOG PC criteria included 72 surgical AEs experi-enced commonly in surgical trials, including 17 gastroen-terological complications, 13 infectious complications, six thoracic complications, and several other complications (Table 1). If no applicable AE terms are found in the JCOG PC criteria, ‘other (specify)’ should be chosen. In such cases, the appropriate AE term should be used, and the
overall grading should be performed in accordance with the general rules of the Clavien-Dindo classification. Because the grading definitions follow the general rules of the Cla-vien-Dindo classification, surgeons can use these original rules to grade AEs, and can also refer to the more detailed definitions in the JCOG PC criteria if necessary. Table 2 lists the differences between CTCAE, the Clavien-Dindo classification, and the JCOG PC criteria.
Discussion
Until Clavien PA et al. published their original classifica-tion in 1992, there were no established criteria or frame-work available to standardize surgical complications in surgical trials. In 2003, the US National Cancer Institute-Common Toxicity Criteria (NCI-CTC) version 2.0 [9] were revised and renamed the CTCAE version 3.0 [10]. This system has been used widely to evaluate and define the toxicity of chemotherapy or radiotherapy. While terms and definitions for AEs occurring as a result of intraopera-tive and postoperative complications were not included in the NCI-CTC version 2.0, some surgical AE terms were incorporated in the CTCAE version 3.0. Nevertheless, the CTCAE version 3.0 failed to include many surgical com-plications and surgeons were frequently unable to objec-tively classify complications using its grading definitions.
In 2009, the CTCAE version 4.0 [11] was released, with considerably more surgical AE terms, but several common surgical complications were still not included. For exam-ple, intra-abdominal abscess, pyothorax, delayed gastric emptying, and lung torsion were not listed as AE terms. Moreover, grading definitions were not clinically optimized for some surgical AEs. For example, the grading defini-tion of pancreatic fistula in this version of the CTCAE is suitable for pancreatitis, but not for pancreatic fistula after pancreatectomy. Such inappropriate definitions have made surgeons reluctant to use the CTCAE version 4.0 in surgi-cal trials.
In 2004, the Clavien-Dindo classification was modified to allow for the grading of life-threatening complications and long-term disability caused by a complication. This revised version defines five grades of severity (Grade I, II, IIIa, IIIb, IVa, IVb, and V) and the suffix “d” (for “disabil-ity”) is used to denote any postoperative impairment [7]. This refined Clavien-Dindo classification has been used increasingly in clinical practice and also in clinical trials involving surgical procedures, because it is simple, repro-ducible, and flexible [12]. Rather than providing specific grading criteria for each AE, the Clavien-Dindo classifica-tion provides broad-based but general criteria that can be used uniformly for all kinds of surgical AEs. However, sev-eral issues have emerged since this classification became
670 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
Lis
t of
surg
ical
adv
erse
eve
nt (
AE
) te
rms
and
grad
ings
Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
AE
term
Any
dev
iatio
n fr
om th
e no
rmal
pos
tope
rativ
e co
urse
with
out t
he n
eed
for
phar
mac
olog
ical
tr
eatm
ent o
r su
rgic
al,
endo
scop
ic, o
r ra
dio-
logi
cal i
nter
vent
ions
. A
llow
ed th
erap
eutic
re
gim
ens
incl
ude
drug
s su
ch a
s an
tiem
etic
s,
antip
yret
ics,
ana
lges
ics,
di
uret
ics,
ele
ctro
lyte
s,
and
phys
ioth
erap
y. T
his
grad
e al
so in
clud
es
wou
nd in
fect
ions
op
ened
at t
he b
edsi
de
Req
uire
men
t for
ph
arm
acol
ogic
al
trea
tmen
t with
dr
ugs
othe
r th
an
thos
e al
low
ed f
or
grad
e I
com
plic
a-tio
nsB
lood
tran
sfus
ions
an
d to
tal p
aren
-te
ral n
utri
tion
are
also
incl
uded
Req
uire
men
t for
su
rgic
al, e
ndos
copi
c or
rad
iolo
gica
l int
er-
vent
ion
not u
nder
ge
nera
l ane
sthe
sia
Req
uire
men
t fo
r su
rgic
al,
endo
scop
ic o
r ra
diol
ogic
al
inte
rven
tion
unde
r ge
nera
l an
esth
esia
Lif
e-th
reat
enin
g co
mpl
icat
ions
(i
nclu
ding
CN
S co
mpl
icat
ions
)*
requ
irin
g IC
/IC
U
man
agem
ent.
Sing
le o
rgan
dys
-fu
nctio
n (i
nclu
ding
di
alys
is)
Lif
e-th
reat
enin
g co
m-
plic
atio
ns (
incl
udin
g C
NS
com
plic
atio
ns)*
re
quir
ing
IC/I
CU
m
anag
emen
t. M
ul-
tiple
org
an d
ysfu
nc-
tion
Dea
th
of th
e pa
tient
If th
e pa
tient
suf
fers
fr
om a
com
plic
a-tio
n at
the
time
of
disc
harg
e, th
e su
f-fix
“d”
(fo
r “d
is-
abili
ty”)
is a
dded
to
the
resp
ectiv
e gr
ade
of c
ompl
i-ca
tion.
Thi
s la
bel
indi
cate
s th
e ne
ed
for
a fo
llow
-up
to
fully
eva
luat
e th
e co
mpl
icat
ion
Stro
keC
linic
al o
bser
vatio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
ticoa
gu-
lant
ther
apy)
Rad
iolo
gica
l int
erve
n-tio
n w
ithou
t gen
eral
an
esth
esia
(e.
g.,
intr
acer
ebro
vasc
ular
tr
eatm
ent)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
drai
nage
, su
rgic
al c
lippi
ng,
cere
brov
ascu
lar
bypa
ss, c
arot
id
enda
rter
ecto
my)
IC/I
CU
man
agem
ent
indi
cate
dIC
/IC
U m
anag
emen
t in
dica
ted;
ass
oci-
ated
with
res
pira
tory
fa
ilure
Dea
thPe
rsis
tent
hem
i-pl
egia
Rec
urre
nt
lary
ngea
l ne
rve
pals
y
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Asp
irat
ion;
med
i-ca
l man
agem
ent
indi
cate
d (e
.g.,
antib
iotic
s)
Seve
re a
spir
atio
n;
food
inta
ke a
lmos
t im
poss
ible
; med
ical
in
terv
entio
n un
der
loca
l ane
sthe
sia
indi
cate
d (e
.g.,
voca
l cor
d in
ject
ion,
tr
ache
al p
unct
ure)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (i
nclu
ding
tra-
cheo
stom
y un
der
seda
tion)
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thH
oars
enes
s, d
iffi-
culty
in s
peak
ing;
co
mm
unic
atio
n th
roug
h w
rit-
ing
nece
ssar
y;
disc
harg
ed w
ith
trac
heos
tom
y
Upp
er e
xtre
m-
ity p
ares
the-
sia
Clin
ical
obs
erva
tion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
edSu
rgic
al in
terv
entio
n w
ithou
t gen
eral
an
esth
esia
indi
cate
d (e
.g.,
nerv
e bl
ock)
––
––
Pers
iste
nt b
rach
ial
pare
sthe
sia
Pare
sthe
sia
in
rese
cted
par
t (P
hant
om
pain
)
Clin
ical
obs
erva
tion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
edSu
rgic
al in
terv
entio
n w
ithou
t gen
eral
an
esth
esia
indi
cate
d (e
.g.,
nerv
e bl
ock)
––
––
Pers
iste
nt p
hant
om
pain
671Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Isch
emic
hea
rt
dise
ase
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
ticoa
gu-
lant
ther
apy)
Car
diac
cat
hete
riza
-tio
n in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (c
oron
ary
arte
ry
bypa
ss)
Hea
rt f
ailu
re a
ssoc
i-at
ed w
ith lo
w
card
iac
outp
ut
synd
rom
e; I
C/
ICU
man
agem
ent
indi
cate
d
Hea
rt f
ailu
re a
ssoc
i-at
ed w
ith lo
w c
ardi
ac
outp
ut s
yndr
ome
and
rena
l fai
lure
; IC
/IC
U m
anag
emen
t in
dica
ted
Dea
thPe
rsis
tent
hea
rt
failu
re f
ollo
win
g m
yoca
rdia
l inf
arc-
tion
Peri
card
ial
effu
sion
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d (d
rain
age
only
th
roug
h ex
istin
g dr
ain-
age
tube
)
Med
ical
man
age-
men
t ind
icat
edIm
age-
guid
ed d
rain
pl
acem
ent/p
ara-
cent
esis
incl
udin
g dr
ain
repl
acem
ent
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (f
enes
trat
ion)
Car
diac
tam
pona
de;
IC/I
CU
man
age-
men
t ind
icat
ed
Car
diac
tam
pona
de
and
rena
l fai
lure
; IC
/IC
U m
anag
emen
t in
dica
ted
Dea
th–
Bra
dyar
rhyt
h-m
iaC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., at
ropi
ne, β
ag
onis
ts)
Med
ical
inte
rven
-tio
n un
der
loca
l an
esth
esia
indi
cate
d (e
.g.,
pace
mak
er
impl
anta
tion)
–H
eart
fai
lure
ass
oci-
ated
with
low
ca
rdia
c ou
tput
sy
ndro
me;
IC
/IC
U m
anag
emen
t in
dica
ted
Hea
rt f
ailu
re a
ssoc
i-at
ed w
ith lo
w c
ardi
ac
outp
ut s
yndr
ome
and
rena
l fai
lure
; IC
/IC
U m
anag
emen
t in
dica
ted
Dea
th–
Supr
aven
tric
u-la
r ar
rhyt
h-m
ia
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tiarr
hyth
-m
ic d
rugs
)
Med
ical
inte
rven
-tio
n un
der
loca
l an
esth
esia
indi
cate
d (e
.g.,
cath
eter
abl
a-tio
n, s
ynch
roni
zed
card
iove
rsio
n)
–H
eart
fai
lure
ass
oci-
ated
with
low
ca
rdia
c ou
tput
sy
ndro
me;
IC
/IC
U m
anag
emen
t in
dica
ted
Hea
rt f
ailu
re a
ssoc
i-at
ed w
ith lo
w c
ardi
ac
outp
ut s
yndr
ome
and
rena
l fai
lure
; IC
/IC
U m
anag
emen
t in
dica
ted
Dea
th–
Ven
tric
ular
ar
rhyt
hmia
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tiarr
hyth
-m
ic d
rugs
)
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d (e
.g.,
cath
eter
abl
atio
n,
exte
rnal
defi
brill
ator
, pa
cem
aker
impl
anta
-tio
n)
–H
eart
fai
lure
ass
oci-
ated
with
low
ca
rdia
c ou
tput
sy
ndro
me;
IC
/IC
U m
anag
emen
t in
dica
ted
Hea
rt f
ailu
re a
ssoc
i-at
ed w
ith lo
w c
ardi
ac
outp
ut s
yndr
ome
and
rena
l fai
lure
; IC
/IC
U m
anag
emen
t in
dica
ted
Dea
th–
Ate
lect
asis
/sp
utum
ex
cret
ion
dif-
ficul
ty
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d, e
xcep
t for
ne
buliz
ers,
exp
ecto
rant
s,
or lu
ng p
hysi
othe
rapy
(e
.g.,
post
ural
dra
inag
e)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Bro
ncho
scop
ic a
spir
a-tio
n or
sur
gica
l in
terv
entio
n in
di-
cate
d (e
.g.,
trac
heal
pu
nctu
re)
with
out
gene
ral a
nest
hesi
a
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (i
nclu
ding
tra-
cheo
stom
y un
der
seda
tion)
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
trac
heos
tom
y
672 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Tra
chea
l fis
tula
, bro
n-ch
ial fi
stul
a
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
–Pr
oced
ure
unde
r lo
cal
anes
thes
ia in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
tube
dra
inag
e,
open
dra
inag
e
Pulm
onar
y fis
tula
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d (d
rain
age
only
th
roug
h ex
istin
g dr
ain-
age
tube
)
–Pr
oced
ure
unde
r lo
cal
anes
thes
ia in
dica
ted
(e.g
., ch
est t
ube
drai
nage
, ple
u-ro
desi
s) in
clud
ing
drai
n re
plac
emen
t in
dica
ted.
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (C
losu
re f
or
pleu
ropa
ren-
chym
al d
efec
ts,
pleu
rode
sis)
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
tube
dra
inag
e,
open
dra
inag
e
Chy
loth
orax
Obs
erva
tion
of c
hy-
lous
dra
inag
e flu
id o
r th
orac
ente
sis
fluid
onl
y (d
rain
age
only
thro
ugh
exis
ting
drai
nage
tube
)
Fat-
rest
rict
ed d
iet,
intr
aven
ous
nutr
i-tio
n in
dica
ted
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
thor
acic
du
ct li
gatio
n)
––
Dea
thPe
rsis
tent
res
-pi
rato
ry d
istr
ess,
m
alnu
triti
on
Pleu
ral e
ffus
ion
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d (d
rain
age
only
th
roug
h ex
istin
g dr
ain-
age
tube
)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., di
uret
ics)
Imag
e-gu
ided
dra
in
plac
emen
t/tho
ra-
cent
esis
incl
udin
g dr
ain
repl
acem
ent
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Mul
tiple
org
an f
ailu
reD
eath
Pers
iste
nt r
espi
ra-
tory
dis
tres
s
Lun
g to
rsio
n–
––
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
deto
rsio
n,
lobe
ctom
y)
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
th–
Asc
ites
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d (d
rain
age
only
th
roug
h ex
istin
g dr
ain-
age
tube
)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., di
uret
ics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
Dea
thPe
rsis
tent
abd
omi-
nal f
ulln
ess
673Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Dia
rrhe
aIn
test
inal
flui
d ex
cre-
tion ≥
2000
ml/d
ay;
inte
rven
tion
not i
ndi-
cate
d
Inte
stin
al
fluid
exc
re-
tion ≥
2000
ml/
day
asso
ciat
ed
with
deh
ydra
tion
or e
lect
roly
te
abno
rmal
ity;
intr
aven
ous
fluid
s in
dica
ted
––
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thSi
gnifi
cant
am
ount
of
per
sist
ent
inte
stin
al fl
uid
excr
etio
n
Dys
phag
iaC
linic
al o
bser
vatio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Ent
eral
/intr
ave-
nous
nut
ritio
n (I
nclu
ding
TPN
) in
dica
ted
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d (e
.g.,
trac
heal
pun
ctur
e,
endo
scop
ic g
astr
os-
tom
y)
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
Dea
thG
astr
osto
my
Inte
stin
al
fistu
laC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
(dra
inag
e on
ly
thro
ugh
exis
ting
drai
n-ag
e tu
be)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (c
olos
tom
y)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
re
nal d
isor
ders
in
dica
ting
dial
ysis
)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
ent
eroc
u-ta
neou
s fis
tula
Inte
stin
al
isch
emia
/ne
cros
is
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Rad
iolo
gica
l int
erve
n-tio
n/en
dosc
opic
/su
rgic
al in
terv
en-
tion
with
out g
ener
al
anes
thes
ia in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
inte
stin
al
rese
ctio
n)
At l
east
one
org
an
failu
re (
e.g.
, pu
lmon
ary
diso
rder
s in
dica
t-in
g m
echa
nica
l ve
ntila
tion
or r
enal
di
sord
ers
indi
cat-
ing
dial
ysis
)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thH
ome
ente
ral/i
ntra
-ve
nous
nut
ritio
n
Gas
tric
tube
ne
cros
isO
bser
vatio
n of
a s
mal
l fis
tula
with
ora
l con
tras
t st
udy
or d
rain
age
imag
ing
(dra
inag
e on
ly
thro
ugh
exis
ting
drai
n-ag
e tu
be)
Med
ical
man
age-
men
t (e.
g., a
nti-
biot
ics)
, ent
eral
/in
trav
enou
s nu
tri-
tion
indi
cate
d
Rad
iolo
gica
l int
erve
n-tio
n/en
dosc
opic
/el
ectiv
e su
rgic
al
inte
rven
tion
with
out
gene
ral a
nest
hesi
a in
dica
ted,
incl
udin
g dr
ain
repl
acem
ent
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
th
674 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Refl
ux
esop
hagi
tisC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
-ag
emen
t (e.
g.,
PPI,
pan
crea
tic
enzy
me
inac
tiva-
tors
) or
ent
eral
/in
trav
enou
s nu
tri-
tion
indi
cate
d
–In
terv
entio
n un
der
gene
ral a
nest
he-
sia
indi
cate
d
––
Dea
thPe
rsis
tent
hea
rtbu
rn
Ileu
s (p
aral
ytic
)C
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; med
ical
man
age-
men
t not
indi
cate
d ex
cept
for
laxa
tives
and
in
trav
enou
s nu
triti
on
Med
ical
man
age-
men
t bey
ond
laxa
tives
, NG
tu
be p
lace
men
t, or
in
trav
enou
s nu
tri-
tion
man
agem
ent
indi
cate
d
Nas
oent
eric
tube
pl
acem
ent
Tre
atm
ent f
or il
eus
unde
r ge
nera
l an
esth
esia
(w
ith
or w
ithou
t int
esti-
nal r
esec
tion)
Ext
ensi
ve in
test
inal
ne
cros
is, a
t lea
st
one
orga
n fa
ilure
(e
.g.,
pulm
onar
y di
sord
ers
requ
irin
g m
echa
nica
l ven
ti-la
tion
or n
ephr
opa-
thy
indi
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thH
ome
intr
aven
ous
nutr
ition
Panc
reat
ic
fistu
laO
n or
aft
er p
osto
pera
tive
day
3, d
rain
age
fluid
am
ylas
e le
vel ≥
3 tim
es th
e up
per
limit
of in
stitu
tiona
l cri
teri
a,
but i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
, en
tera
l/int
rave
-no
us n
utri
tion
indi
cate
d
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual p
ancr
eatic
ps
eudo
cyst
on
CT,
oc
casi
onal
fev
er,
or a
bdom
inal
pai
n
Inte
stin
al
obst
ruct
ion
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; m
edic
al m
anag
e-m
ent n
ot in
dica
ted
exce
pt f
or la
xativ
es a
nd
intr
aven
ous
nutr
ition
Med
ical
man
age-
men
t bey
ond
laxa
tives
, NG
tu
be p
lace
men
t, or
in
trav
enou
s nu
tri-
tion
man
agem
ent
indi
cate
d
Nas
oent
eric
tube
pl
acem
ent
Tre
atm
ent f
or il
eus
unde
r ge
nera
l an
esth
esia
(w
ith
or w
ithou
t int
esti-
nal r
esec
tion)
Ext
ensi
ve in
test
inal
ne
cros
is, a
t lea
st
one
orga
n fa
ilure
(e
.g.,
pulm
onar
y di
sord
ers
requ
irin
g m
echa
nica
l ven
ti-la
tion
or n
ephr
opa-
thy
indi
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thH
ome
intr
aven
ous
nutr
ition
Del
ayed
gas
tric
em
ptyi
ngC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t (e.
g., p
eri-
stal
sis
stim
ulat
-in
g dr
ugs)
, NG
tu
be p
lace
men
t, en
tera
l/int
rave
-no
us n
utri
tion
indi
cate
d
–In
terv
entio
n un
der
gene
ral a
nest
he-
sia
indi
cate
d
––
Dea
thPe
rsis
tent
pos
tpra
n-di
al n
ause
a
675Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Dum
ping
sy
ndro
me
Clin
ical
obs
erva
tion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed–
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
Dea
thPe
rsis
tent
dum
ping
sy
mpt
om
Bili
ary
fistu
laC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
(dra
inag
e on
ly
thro
ugh
exis
ting
drai
n-ag
e tu
be)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual p
seud
ocys
t on
CT;
occ
asio
nal
feve
r or
abd
omi-
nal p
ain
Cho
lecy
stiti
sC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; med
ical
man
age-
men
t not
indi
cate
d ex
cept
for
cho
lago
gues
Med
ical
man
age-
men
t bey
ond
chol
agog
ues
indi
cate
d
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d (e
.g.,
Perc
utan
eous
tran
-sh
epat
ic g
allb
ladd
er
drai
nage
)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (c
hole
cyst
ec-
tom
y)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thO
ccas
iona
l fev
er o
r ab
dom
inal
pai
n
Gas
troi
ntes
tinal
an
asto
mot
ic
leak
Onl
y sm
all fi
stul
a ob
serv
ed o
n or
al c
on-
tras
t stu
dy o
r dr
aina
ge
imag
ing
(dra
inag
e on
ly
thro
ugh
exis
ting
drai
n-ag
e tu
be)
Med
ical
man
age-
men
t (e.
g., a
ntib
i-ot
ics)
or
ente
ral/
intr
aven
ous
nutr
i-tio
n (I
nclu
ding
T
PN)
indi
cate
d
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
wou
nd o
peni
ng o
r dr
ain
repl
acem
ent
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
sutu
re,
rean
asto
mos
is,
bypa
ss, d
rain
age,
co
lost
omy)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thH
ome
ente
ral/i
ntra
-ve
nous
nut
ritio
n
Ure
teri
c in
jury
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Tra
nsur
ethr
al u
rete
ral
sten
t ins
ertio
n or
per
cuta
neou
s ne
phro
stom
y
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
Acu
te r
enal
fai
lure
, he
mod
ialy
sis
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
uret
eral
ste
nt
Ure
thra
l inj
ury
Fole
y ca
thet
er p
lace
men
tM
edic
al m
anag
e-m
ent i
ndic
ated
(e
.g.,
antib
iotic
s)
Inte
rven
tion
unde
r lo
cal o
r lu
mba
r an
esth
esia
indi
cate
d (e
.g.,
perc
utan
eous
cy
stos
tom
y)
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
Fole
y ca
thet
er
plac
emen
t
676 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Post
oper
ativ
e he
mor
rhag
eC
ontr
olla
ble
with
com
-pr
essi
on o
nly
Blo
od tr
ansf
usio
n or
med
ical
man
-ag
emen
t ind
icat
ed
Surg
ical
hem
osta
sis
unde
r lo
cal a
nest
he-
sia
or e
ndos
copi
c an
d ra
diol
ogic
al
inte
rven
tion
hem
o-st
asis
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (h
emos
tasi
s)
Sing
le o
rgan
fai
lure
; st
epdo
wn
ICU
/IC
U
care
indi
cate
d
Mul
tiple
org
an f
ailu
re;
IC/I
CU
man
agem
ent
indi
cate
d
Dea
thPe
rsis
tent
ane
mia
Sero
ma
(Acc
umul
atio
n of
ser
ous
fluid
)
Bed
side
par
acen
tesi
s on
ly
(dra
inag
e on
ly th
roug
h ex
istin
g dr
aina
ge tu
be)
–Im
age-
guid
ed d
rain
pl
acem
ent/p
ara-
cent
esis
incl
udin
g dr
ain
repl
acem
ent
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thE
xuda
te le
akag
e fr
om w
ound
, oc
casi
onal
fev
er
and
infe
ctio
n,
disc
harg
ed w
ith
drai
nage
tube
Ute
rine
ana
sto-
mot
ic le
akC
linic
al o
r va
gina
l obs
er-
vatio
n on
ly; i
nter
vent
ion
not i
ndic
ated
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
–In
terv
entio
n un
der
gene
ral a
nes-
thes
ia in
dica
ted
(res
utur
ing)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
leak
age
from
ute
rova
gina
l an
asto
mos
is d
ue
to s
utur
e fa
ilure
(s
urgi
cal u
nion
of
two
diff
eren
t ana
-to
mic
al s
truc
ture
s)
Abd
omin
al
inci
sion
al
hern
ia
Clin
ical
obs
erva
tion
only
; in
terv
entio
n no
t ind
i-ca
ted
exce
pt f
or tr
uss
and
NSA
IDs
Med
ical
man
age-
men
t bey
ond
trus
s an
d N
SAID
s in
dica
ted
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (m
esh,
fas
cial
re
sutu
ring
)
Ext
ensi
ve in
test
inal
ne
cros
is, a
t lea
st
one
orga
n fa
ilure
(e
.g.,
pulm
onar
y di
sord
ers
requ
irin
g m
echa
nica
l ven
ti-la
tion
or n
ephr
opa-
thy
indi
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thIn
test
inal
pro
laps
e up
on in
crea
sed
intr
a-ab
dom
inal
pr
essu
re
Wou
nd d
ehis
-ce
nce
Clin
ical
obs
erva
tion
only
; in
terv
entio
n no
t ind
i-ca
ted
exce
pt f
or w
ound
ir
riga
tion
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d (e
.g.,
resu
turi
ng)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
resu
turi
ng)
Ext
ensi
ve in
test
inal
ne
cros
is, a
t lea
st
one
orga
n fa
ilure
(e
.g.,
pulm
onar
y di
sord
ers
requ
irin
g m
echa
nica
l ven
ti-la
tion
or n
ephr
opa-
thy
indi
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
sign
ifica
nt w
ound
de
hisc
ence
677Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Gas
troi
ntes
tinal
an
asto
mot
ic
sten
osis
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Ent
eral
/intr
ave-
nous
nut
ritio
n (I
nclu
ding
TPN
) in
dica
ted
Bal
loon
dila
tatio
n,
sten
ting,
mag
netic
co
mpr
essi
on a
nast
o-m
osis
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
rean
asto
-m
osis
, byp
ass)
––
Dea
thFr
eque
nt o
utpa
tient
en
dosc
opic
dila
ta-
tion
Intr
aabd
omin
al
absc
ess
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on C
T, o
ccas
iona
l fe
ver
or a
bdom
i-na
l pai
n
Pelv
ic a
bsce
ssC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on C
T, o
ccas
iona
l fe
ver
or a
bdom
i-na
l pai
n
Pneu
mon
iaC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
exce
pt f
or
nebu
lizer
s, e
xpec
tora
nts,
or
lung
phy
siot
hera
py
(e.g
., po
stur
al d
rain
age)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Bro
ncho
scop
ic
aspi
ratio
n, tr
ache
al
punc
ture
Tra
cheo
stom
y un
der
gene
ral
anes
thes
ia/s
eda-
tion
or m
echa
ni-
cal v
entil
atio
n
Mec
hani
cal v
entil
a-tio
n in
dica
ted
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
res
-pi
rato
ry d
istr
ess,
oc
casi
onal
fev
er
Med
iast
initi
sC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on C
T im
ages
, oc
casi
onal
fev
er
or a
bdom
inal
pai
n
Pyot
hora
xC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on C
T im
ages
or
disc
harg
ed w
ith
tube
dra
inag
e,
open
dra
inag
e
678 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Low
er
extr
emity
ly
mph
angi
tis(L
ymph
nod
e in
fect
ion)
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Med
ical
inte
rven
-tio
n un
der
loca
l an
esth
esia
indi
cate
d (l
ymph
atic
ana
sto-
mos
is)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (l
ymph
atic
an
asto
mos
is)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
–Pe
rsis
tent
ede
ma
Infe
cted
lym
-ph
ocel
e(R
etro
peri
to-
neal
abs
cess
)
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Dra
inag
e un
der
loca
l ane
sthe
sia
or
with
out a
nest
hesi
a in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (i
ncis
ion
and
drai
nage
)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on im
agin
g st
udy,
oc
casi
onal
fev
er
or a
bdom
inal
pai
n
Infe
ctio
us
cerv
iciti
sC
linic
al o
r va
gina
l obs
er-
vatio
n on
ly; i
nter
vent
ion
not i
ndic
ated
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Dra
inag
e un
der
loca
l ane
sthe
sia
or
with
out a
nest
hesi
a in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age,
hys
ter-
ecto
my)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
infe
cted
va
gina
l dis
char
ge
Ute
rine
infe
c-tio
nC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Dila
tion
and
cure
ttage
un
der
loca
l ane
s-th
esia
or
with
out
anes
thes
ia in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age,
hys
ter-
ecto
my)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on im
agin
g st
udy,
oc
casi
onal
fev
er
or a
bdom
inal
pai
n
Ova
rian
infe
c-tio
nC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Para
cent
esis
dra
inag
e un
der
loca
l ane
sthe
-si
a in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age,
oop
ho-
rect
omy)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on im
agin
g st
udy,
oc
casi
onal
fev
er
or a
bdom
inal
pai
n
679Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Vul
val i
nfec
-tio
nC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Para
cent
esis
dra
inag
e un
der
loca
l ane
sthe
-si
a in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (d
rain
age,
ski
n fla
p, o
r m
uscu
-lo
cuta
neou
s fla
p)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thR
esid
ual a
bsce
ss
on im
agin
g st
udy,
oc
casi
onal
fev
er
or a
bdom
inal
pai
n
Wou
nd in
fec-
tion
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d, e
xcep
t for
w
ound
ope
ning
and
w
ound
irri
gatio
n at
the
beds
ide
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d (e
.g.,
drai
nage
)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
drai
nage
, re
sutu
ring
)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thC
ontin
ued
outp
a-tie
nt ir
riga
tion
Impl
ant i
nfec
-tio
nC
linic
al o
bser
vatio
n or
di
agno
stic
eva
luat
ion
only
; int
erve
ntio
n no
t in
dica
ted
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Med
ical
inte
rven
-tio
n un
der
loca
l an
esth
esia
indi
cate
d (e
.g.,
inci
sion
and
dr
aina
ge, i
mpl
ant
rem
oval
)
Inte
rven
tion
unde
r ge
nera
l an
esth
esia
indi
-ca
ted
(im
plan
t re
mov
al)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
drai
nage
tube
pl
acem
ent;
pers
is-
tent
infe
ctio
n
Bla
dder
inju
ryFo
ley
cath
eter
pla
cem
ent
indi
cate
dM
edic
al m
anag
e-m
ent i
ndic
ated
(e
.g.,
antib
iotic
s)
–In
terv
entio
n un
der
gene
ral a
nest
he-
sia
indi
cate
d
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thD
isch
arge
d w
ith
Fole
y ca
thet
er
plac
emen
t
Uri
nary
inco
n-tin
ence
Inte
rmitt
ent c
athe
teri
za-
tion
or F
oley
cat
hete
r pl
acem
ent i
ndic
ated
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
ticho
lin-
ergi
cs)
Inte
rven
tion
unde
r lo
cal o
r lu
mba
r an
esth
esia
indi
cate
d (e
.g.,
clam
p, c
ol-
lage
n in
ject
ion)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
artifi
cial
ur
inar
y sp
hinc
ter)
Acu
te r
enal
fai
lure
, he
mod
ialy
sis
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
con
ditio
n re
quir
ing
Inte
rmit-
tent
cat
hete
riza
-tio
n; D
isch
arge
d w
ith F
oley
cat
h-et
er p
lace
men
t
680 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Res
idua
l uri
ne/
Uri
nary
re
tent
ion
Inte
rmitt
ent c
athe
teri
za-
tion
or F
oley
cat
hete
r pl
acem
ent i
ndic
ated
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., ch
olin
er-
gics
)
Inte
rven
tion
unde
r lo
cal o
r lu
mba
r an
esth
esia
indi
cate
d (e
.g.,
endo
scop
ic
trea
tmen
t, ur
ethr
al
dila
tatio
n)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
fistu
la
clos
ure)
Acu
te r
enal
fai
lure
, he
mod
ialy
sis
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
con
ditio
n re
quir
ing
inte
rmit-
tent
cat
hete
riza
-tio
n; D
isch
arge
d w
ith F
oley
cat
h-et
er p
lace
men
t
Dys
pare
unia
Dis
com
fort
ass
ocia
ted
with
vag
inal
pen
etra
-tio
n; in
terv
entio
n no
t in
dica
ted
Est
roge
n ad
min
is-
trat
ion
indi
cate
dM
edic
al in
terv
entio
n un
der
loca
l ane
sthe
-si
a in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
–Pe
rsis
tent
pai
n as
soci
ated
with
se
xual
inte
rcou
rse,
pe
rsis
tent
dys
-pa
reun
ia
Ere
ctile
dys
-fu
nctio
nE
rect
ile d
ysfu
nctio
n;
inte
rven
tion
not
indi
cate
d, e
xcep
t for
ex
tern
al v
acuu
m d
evic
e fo
r m
anag
ing
erec
tile
dysf
unct
ion
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., Ph
osph
odi-
este
rase
5 in
hibi
-to
rs o
r in
trac
av-
erno
sal i
njec
tion
of v
asoa
ctiv
e ag
onis
ts)
Inte
rven
tion
unde
r lo
cal o
r lu
mba
r an
es-
thes
ia in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (e
.g.,
peni
le
pros
thes
is)
––
–Pe
rsis
tent
ere
ctile
dy
sfun
ctio
n
Cer
vica
l atr
esia
(u
teri
ne
atre
sia)
Clin
ical
or
vagi
nal o
bser
-va
tion
only
; int
erve
ntio
n no
t ind
icat
ed
Ass
ocia
ted
with
dy
smen
orrh
ea;
med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
alge
sics
)
Bou
gien
age
of c
ervi
-ca
l duc
t with
or
with
out l
ocal
ane
s-th
esia
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
(cer
-vi
cal d
ilata
tion)
––
–Pe
rsis
tent
ste
nosi
s of
the
cerv
ical
os
Vag
inal
fist
ula
Clin
ical
or
vagi
nal o
bser
-va
tion
only
; int
erve
ntio
n no
t ind
icat
ed
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
–In
terv
entio
n un
der
gene
ral a
nes-
thes
ia in
dica
ted
(vag
inal
fist
ula
clos
ure,
col
os-
tom
y)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thPe
rsis
tent
leak
age
from
vag
ina
Ova
rian
de
ficie
ncy
synd
rom
e
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., ho
rmon
e re
plac
emen
t th
erap
y)
––
––
Dea
thH
ot fl
ash
requ
irin
g co
ntin
ued
hor-
mon
e re
plac
emen
t th
erap
y, d
epre
s-si
on r
equi
ring
co
ntin
ued
psyc
hi-
atri
c ca
re
681Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Cer
vica
l chy
-lo
us le
akag
eO
bser
vatio
n of
chy
lous
dr
aina
ge fl
uid
or p
ara-
cent
esis
flui
d on
ly; i
nter
-ve
ntio
n no
t ind
icat
ed
(dra
inag
e on
ly th
roug
h ex
istin
g dr
aina
ge tu
be)
Fat-
rest
rict
ed d
iet,
intr
aven
ous
nutr
i-tio
n in
dica
ted
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted.
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
Dea
thPe
rsis
tent
sen
satio
n of
pre
ssur
e in
the
neck
Sero
us le
akag
eC
linic
al o
bser
vatio
n on
ly; i
nter
vent
ion
not
indi
cate
d (d
rain
age
only
th
roug
h ex
istin
g dr
ain-
age
tube
)
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thE
xuda
te le
akag
e fr
om th
e w
ound
, oc
casi
onal
fev
er
and
infe
ctio
n,
disc
harg
ed w
ith
drai
nage
tube
Chy
lous
asc
ites
Obs
erva
tion
of c
hylo
us
drai
nage
flui
d or
par
a-ce
ntes
is fl
uid
only
; int
er-
vent
ion
not i
ndic
ated
(d
rain
age
only
thro
ugh
exis
ting
drai
nage
tube
)
Fat-
rest
rict
ed d
iet,
intr
aven
ous
nutr
i-tio
n in
dica
ted
Imag
e-gu
ided
dra
in
plac
emen
t/par
a-ce
ntes
is in
clud
ing
drai
n re
plac
emen
t in
dica
ted
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
Dea
thPe
rsis
tent
abd
omi-
nal f
ulln
ess
Subc
utan
eous
ph
lebi
tis
(Mon
dor
dise
ase)
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d ex
cept
for
N
SAID
s
Opi
oid
adm
inis
tra-
tion,
or
trea
tmen
t by
pai
n co
ntro
l sp
ecia
list i
ndi-
cate
d
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
–Su
rgic
al s
ite s
ubcu
-ta
neou
s ph
lebi
tis;
cord
-lik
e m
ass
Thr
ombo
sis/
embo
lism
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
ticoa
gu-
lant
s)
Inva
sive
trea
tmen
t in
dica
ted
(e.g
., th
rom
bus
abla
tion
via
cath
eter
, IV
C
filte
r)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (p
ulm
onar
y ar
tery
thro
mbe
c-to
my)
Sing
le o
rgan
fai
lure
ca
used
by
thro
mbi
(e
.g.,
lung
, bra
in,
hear
t)
Mul
tiple
org
an f
ailu
re
caus
ed b
y th
rom
bi
(e.g
., lu
ng, b
rain
, he
art)
Dea
thD
yspn
ea f
ollo
win
g pu
lmon
ary
infa
rc-
tion,
par
alys
is
follo
win
g ce
rebr
al
infa
rctio
n
Res
tric
ted
shou
lder
jo
int r
ange
of
mot
ion
Clin
ical
obs
erva
tion
only
; int
erve
ntio
n no
t in
dica
ted
exce
pt f
or
NSA
IDs
Opi
oid
adm
inis
tra-
tion,
or
trea
tmen
t by
pai
n co
ntro
l sp
ecia
list i
ndi-
cate
d
Surg
ical
inte
rven
tion
with
out g
ener
al
anes
thes
ia in
dica
ted
(e.g
., ne
rve
bloc
k)
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
–C
ontin
ued
rest
ric-
tion
in th
e ra
nge
of m
otio
n of
the
shou
lder
join
t
682 Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Fat n
ecro
sis
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d ex
cept
for
w
ound
ope
ning
and
w
ound
irri
gatio
n at
the
beds
ide
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Med
ical
inte
rven
-tio
n un
der
loca
l an
esth
esia
indi
cate
d (e
.g.,
inci
sion
and
dr
aina
ge)
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thW
ound
fat
nec
rosi
s,
occa
sion
al c
icat
ri-
zatio
n, f
ever
or
infe
ctio
n
Skin
nec
rosi
s (fl
ap n
ecro
-si
s)
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., an
tibio
tics)
Med
ical
inte
rven
tion
unde
r lo
cal a
nest
he-
sia
indi
cate
d (e
.g.,
debr
idem
ent,
skin
gr
aftin
g)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (s
kin
graf
ting)
At l
east
one
org
an
failu
re (
e.g.
, pul
-m
onar
y di
sord
ers
requ
irin
g m
echa
ni-
cal v
entil
atio
n or
ne
phro
path
y in
di-
catin
g di
alys
is)
Seps
is o
r m
ultip
le
orga
n fa
ilure
Dea
thIn
suffi
cien
t epi
the-
lializ
atio
n, p
ersi
s-te
nt in
fect
ion
Subc
utan
eous
em
phys
ema
Clin
ical
obs
erva
tion
or
diag
nost
ic e
valu
atio
n on
ly; i
nter
vent
ion
not
indi
cate
d ex
cept
for
sub
-cu
tane
ous
punc
ture
and
co
mpr
essi
on w
ith b
reas
t ba
nd a
t the
bed
side
–R
adio
logi
cal i
nter
-ve
ntio
n tr
eatm
ent
with
out g
ener
al
anes
thes
ia in
dica
ted
(e.g
., su
bcut
aneo
us
drai
n in
sert
ion)
Inte
rven
tion
unde
r ge
nera
l ane
sthe
-si
a in
dica
ted
––
–D
isch
arge
d w
ith
subc
utan
eous
air
ac
cum
ulat
ion
Upp
er e
xtre
m-
ity e
dem
aIn
terv
entio
n no
t ind
icat
ed
exce
pt f
or ly
mph
atic
m
assa
ge a
nd e
last
ic
stoc
king
s
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., di
uret
ics)
Inte
rven
tion
unde
r lo
cal a
nest
hesi
a in
dica
ted
(lym
phat
ic
anas
tom
osis
)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (l
ymph
atic
an
asto
mos
is)
––
–C
ontin
ued
elas
tic
stoc
king
use
Low
er
extr
emity
ly
mph
edem
a (e
dem
a of
the
extr
emiti
es,
lym
phed
ema,
lo
caliz
ed
edem
a)
Inte
rven
tion
not i
ndic
ated
ex
cept
for
lym
phat
ic
mas
sage
and
ela
stic
st
ocki
ngs
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., di
uret
ics)
Inte
rven
tion
unde
r lo
cal a
nest
hesi
a in
dica
ted
(lym
phat
ic
anas
tom
osis
)
Inte
rven
tion
unde
r ge
nera
l ane
s-th
esia
indi
cate
d (l
ymph
atic
an
asto
mos
is)
––
–C
ontin
ued
elas
tic
stoc
king
use
Obt
urat
or/
fem
oral
neu
-ro
path
y (G
ait
dist
urba
nce)
Inte
rven
tion
not i
ndic
ated
ex
cept
for
wal
king
aid
an
d re
habi
litat
ion
Med
ical
man
age-
men
t ind
icat
ed
(e.g
., vi
tam
ins)
–In
terv
entio
n un
der
gene
ral a
nes-
thes
ia in
dica
ted
(e.g
., ne
rve
sutu
re)
––
–Pe
rsis
tent
res
tric
tion
in lo
wer
ext
rem
ity
addu
ctio
n
683Surg Today (2016) 46:668–685
1 3
Tabl
e 1
con
tinue
d Prin
cipl
e of
gra
ding
III
IIIa
IIIb
IVa
IVb
VSu
pple
men
tal
expl
anat
ion
of
suf
fix “
d”
Wou
nd p
ain
Clin
ical
obs
erva
tion
only
; int
erve
ntio
n no
t in
dica
ted
exce
pt f
or
NSA
IDs
Opi
oid
adm
inis
tra-
tion,
or
trea
tmen
t by
pai
n co
ntro
l sp
ecia
list i
ndi-
cate
d
Surg
ical
inte
rven
tion
indi
cate
d (e
.g.,
nerv
e bl
ock)
––
––
Hom
e pa
in c
ontr
ol
Oth
ers
(No
AE
te
rm)
Dev
iatio
n fr
om n
orm
al
post
oper
ativ
e co
urse
. M
edic
atio
n, s
urgi
cal
inte
rven
tion,
end
osco
pic
trea
tmen
t, or
rad
iolo
gi-
cal i
nter
vent
ion
trea
t-m
ent n
ot in
dica
ted
Tre
atm
ent w
ith a
ntie
met
-ic
s, a
ntip
yret
ics,
ana
lge-
sics
, or
diur
etic
s; e
lec-
trol
yte
repl
enis
hmen
t; or
ph
ysic
al th
erap
y is
not
in
clud
ed in
this
cat
egor
y (e
ven
if th
ese
trea
t-m
ents
are
indi
cate
d, th
e co
nditi
on is
cat
egor
ized
as
Gra
de I
); o
pen
wou
nd
infe
ctio
n at
the
beds
ide
is G
rade
I
Med
icat
ion
indi
cate
d ex
cept
fo
r an
tiem
et-
ics,
ant
ipyr
etic
s,
anal
gesi
cs, a
nd
diur
etic
sC
ases
req
uiri
ng
bloo
d tr
ansf
usio
n or
intr
aven
ous
hype
ralim
enta
tion
are
incl
uded
Surg
ical
, end
osco
pic,
or
rad
iolo
gica
l int
er-
vent
ion
trea
tmen
t in
dica
ted
(with
out
gene
ral a
nest
hesi
a)
Surg
ical
, end
o-sc
opic
, rad
iolo
gi-
cal i
nter
vent
ion
trea
tmen
t ind
i-ca
ted
(int
erve
n-tio
n un
der
gen-
eral
ane
sthe
sia)
IC/I
CU
man
agem
ent
indi
cate
d; li
fe-
thre
aten
ing
com
-pl
icat
ions
(in
clud
-in
g co
mpl
icat
ions
in
the
cent
ral
nerv
ous
syst
em)
AN
D s
ingl
e or
gan
failu
re (
incl
udin
g di
alys
is)
IC/I
CU
man
agem
ent
indi
cate
d; li
fe-t
hrea
t-en
ing
com
plic
atio
ns
(inc
ludi
ng c
ompl
ica-
tions
in th
e ce
ntra
l ne
rvou
s sy
stem
) A
ND
mul
tiple
org
an
failu
re
Dea
th
IC in
term
edia
te c
are,
IC
U in
tens
ive
care
uni
t, T
PN
tota
l par
ente
ral n
utri
tion,
PP
I pr
oton
pum
p in
hibi
tor,
NG
tube
nas
ogas
tric
tube
, CT
com
pute
d to
mog
raph
y
684 Surg Today (2016) 46:668–685
1 3
more widely used. One controversial issue is that AE terms are not well defined and different AE terms designate the same AEs in different clinical trials. For example, when intestinal obstruction occurs, some investigators could report this AE as “ileus”, but others refer to it as “small bowel obstruction” or “colon obstruction”. Under such circumstances, the incidence of this AE cannot be counted accurately. A second issue is that only general grading cri-teria are defined and therefore, grading can be difficult in some cases and subject to bias by the grader. For example, primary non-operative treatment for intestinal obstruction is gastroenteric tube decompression. Nasogastric tube or nasoenteric tube is utilized depending on the severity, but the original Clavien-Dindo classification does not define what grading should be applied for any type of gastroen-teric tube placement for decompression.
The JCOG PC criteria were established to address these issues. The advantages of the JCOG PC criteria are as fol-lows: First, commonly experienced surgical AEs are speci-fied and listed. To compare precisely the frequency of surgi-cal complications between studies, use of the common AE terms specified in the JCOG PC criteria is recommended. Second, grading definitions are straightforward and opti-mized for surgical complications. With these advantages, the JCOG recommends that the JCOG PC criteria be used to supplement the Clavien-Dindo classification, while maintaining the overall Clavien-Dindo classification. In JCOG, some disease-oriented subgroups are conducting clinical trials including surgery and using both the CTCAE and JCOG PC criteria to evaluate postoperative compli-cations. After these trials are completed, we will evaluate the concordance between the grading by the CTCAE and that by the JCOG PC criteria. We also plan to explore the advantages and disadvantages of the JCOG PC criteria.
The JCOG PC criteria have some limitations. First, these AE terms were chosen somewhat arbitrarily, but by experi-enced surgeons, and specific grading was decided based on the opinions and experience of our committee members. A second limitation of the JCOG PC criteria is that they do not include intraoperative complications. Our intent was to further define and clarify the criteria of the Clavien-Dindo classification and we considered that incorporating intra-operative complications would deviate too much from the original concept. Another common classification may be
required to define and grade intraoperative complications. A third limitation is that all descriptions in the Clavien-Dindo classification pertain to early postoperative com-plications. Here, ‘early postoperative’ generally indicates the time from surgery to the first hospital discharge, but in theory, the Clavien-Dindo classification can be applied broadly to late postoperative complications after hospital discharge. Within this context, the JCOG PC criteria are mainly intended to be used for early postoperative compli-cations, but they can also be used after hospital discharge, although would require more definitions and AEs.
In conclusion, the goals of the JCOG PC criteria are to standardize the AE terms used for early postoperative com-plications by providing more detailed grading guidelines based on the Clavien-Dindo classification. We suggest that researchers use the JCOG PC criteria in every surgical trial to allow for precise comparison of the frequency of surgical complications among trials.
Acknowledgments This project was supported by the National Cancer Center Research and Development Fund (23-A-16, 26-A-4). We thank Hiroaki Hiraga and Yasuji Miyakita for their specialist advice.
Compliance with ethical standards
Conflict of interest Hiroshi Katayama and his coauthors declare no conflicts of interest regarding this research.
Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://crea-tivecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
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Table 2 Characteristics of the three criteria
CTCAE ver4.0 Clavien-Dindo classification JCOG PC criteria
AE terms Specified Not specified Specified
Grading definitions Defined for each AE Single common definition for all AEs Defined for each AE (following the general definition of the Clavien-Dindo classification)
685Surg Today (2016) 46:668–685
1 3
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