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TBE-CITETBE-CITE
TBE-CITETBE-CITE
TBE-CITE
Not complicated acute appendicitis in adults: clinical or surgicalNot complicated acute appendicitis in adults: clinical or surgical
Not complicated acute appendicitis in adults: clinical or surgicalNot complicated acute appendicitis in adults: clinical or surgical
Not complicated acute appendicitis in adults: clinical or surgical
treatment?treatment?
treatment?treatment?
treatment?
Apendicite aguda não complicada em adultos: tratamento cirúrgico ou clínico?Apendicite aguda não complicada em adultos: tratamento cirúrgico ou clínico?
Apendicite aguda não complicada em adultos: tratamento cirúrgico ou clínico?Apendicite aguda não complicada em adultos: tratamento cirúrgico ou clínico?
Apendicite aguda não complicada em adultos: tratamento cirúrgico ou clínico?
ELCIO SHIYOITI HIRANO,TCBC-SP
1
; BRUNO MONTEIRO TAVARES PEREIRA
2
; JOAQUIM MURRAY BUSTORFF-SILVA
3
; SANDRO RIZOLI
4
; BARTOLOMEU
NASCIMENTO JR
5
; GUSTAVO PEREIRA FRAGA,TCBC-SP
6
TBE-CiTE Journal Meeting on February 27TBE-CiTE Journal Meeting on February 27
TBE-CiTE Journal Meeting on February 27TBE-CiTE Journal Meeting on February 27
TBE-CiTE Journal Meeting on February 27
thth
thth
th
, 2012, with the participation of the following services:, 2012, with the participation of the following services:
, 2012, with the participation of the following services:, 2012, with the participation of the following services:
, 2012, with the participation of the following services: Trauma Program,
Department of Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Canada; Discipline of Trauma Surgery at UNICAMP,
Campinas, São Paulo, Brazil; Discipline of Trauma and Emergency Surgery, Department of Surgery and Anatomy, Faculty of Medicine of
Ribeirao Preto, University of São Paulo (USP), Brazil; Federal District Base Hospital, Brasília, Federal District, Brazil; Federal University of
Amazonas (UFAM), Manaus , Amazonas, Brazil; and Antônio Pedro University Hospital, Fluminense Federal University, Niterói, Rio de Janeiro,
Brazil.
1. PhD, Attending Physician, Discipline of Trauma Surgery, Department of Surgery, Faculty of Medical Sciences, State University of Campinas
UNICAMP; 2. Attending Physician, Discipline of Trauma Surgery, Department ofSurgery, Faculty of Medical Sciences, State University of Campinas
UNICAMP; 3. Professor, Pediatric Surgery, Chief, Department of Surgery, Faculty of Medical Sciences, State University of Campinas – UNICAMP;
4. PhD, Associate Professor, Surgery and Intensive Care, Departments of Surgery and Intensive Care, University of Toronto; 5. Fellow, Trauma
Program, Department of Surgery, University of Toronto; 6. PhD, Coordinating Professor, Discipline of Trauma Surgery, Department of Surgery,
Faculty of Medical Sciences, State University of Campinas – UNICAMP.
INTRODUCTIONINTRODUCTION
INTRODUCTIONINTRODUCTION
INTRODUCTION
A
cute appendicitis is one of the most common causes
of acute abdomen and can be classified into
uncomplicated and complicated (phlegmon and / or
peritonitis). Although it was originally described more than
125 years ago, the etiology of acute appendicitis continues
to be debated. Classically, the obstruction of the appendix
by a fecalith, foreign bodies, parasites, tumors and lymph
node hyperplasia, have been implicated in the development
of acute appendicitis. According to this theory, acute
appendicitis is considered as a progressive condition, which
begins with the increase in mucus secretion and intraluminal
pressure, resulting in venous stasis and arterial ischemic
compression of the walls of the viscus. With ischemia,
mucosal protective mechanism of the barrier is lost, leading
to bacterial invasion of the appendix wall, which in turn
facilitates perforation and infarction of the appendix. Based
on the concept of unavoidable complication, surgical
removal of the appendix has been the treatment of choice
for over a century
1
. However, the observation of spontaneous
resolution of acute appendicitis cases and reports of some
authors of a good outcome in patients treated with
antibiotics suggest that not all cases of acute appendicitis
fall in the theory of mechanical obstruction and progression
to complicated disease
2,3
. Some researchers suggest that
the forms uncomplicated and complicated of appendicitis
are two distinct diseases, with different etiologies. As in
other intra-abdominal infections, such as salpingitis,
diverticulitis and enterocolitis, which are often treated only
with antibiotics, the infectious etiology of acute appendicitis
is advocated by some scholars
4
.
Although appendectomy is the approach adopted
in most institutions, there have been, since 1959, reports
of non-operative treatment with use of antibiotics of both
clinical presentations
2
. In cases of appendiceal phlegmon,
medical treatment with antibiotics in the initial phase is
commonly used by many surgeons
5,6
.
In recent years a number of retrospective and
prospective scientific studies have been conducted with the
purpose of comparing surgical treatment with conservative
(nonoperative) one
6-10
. Nevertheless, the conduction of
comparative studies in this area is challenging due to the
following factors: 1) Acute appendicitis is a disease that
has a broad spectrum of clinical presentations and various
diagnostic methods (clinical, laboratory, ultrasound, CT and
surgical) can be used and vary between the various surgical
services, which challenges the diagnostic classification of
patients for inclusion in studies; 2) The population affected
by appendicitis is heterogeneous, including different age
groups, making the comparison between patients
burdensome; 3) The overall mortality rate associated
with acute appendicitis is relatively low, which makes it
extremely difficult to assess and demonstrate differences
in mortality in scientific papers; 4) There is difficulty in
defining “success” or “superiority” of surgical treatment
when compared to the conservative one, and “equivalence”
or “no inferiority” of antibiotic therapy to appendectomy,
in order to allow comparison. The variability of the profile
of the population studied, the surgical technique used, the
diagnostic methods, the choice and duration of antibiotic
therapy, the frequency and criteria for review, the inclusion
and exclusion criteria, and methods of study, are responsible
for inconsistency of results, hampering inter-trial
interpretation
6-8
.
Institutions that participated in the TBE-CiTE
conducted a critical analysis of two original articles and
two recent systematic reviews on the subject and generated
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Not complicated acute appendicitis in adults: clinical or surgical treatment?
recommendations “based on that evidence” about the
validity of nonoperative treatment of uncomplicated acute
appendicitis in adults.
STUDY 1STUDY 1
STUDY 1STUDY 1
STUDY 1
Randomized clinical trial of antibiotic therapy
versus appendectomy as initial treatment of acute
appendicitis in unselected patients
9
.
RationaleRationale
RationaleRationale
Rationale
The result of the non-operative treatment
(antibiotics) of acute appendicitis is uncertain. This study
was designed to evaluate the use of antibiotics in the
treatment of acute appendicitis in unselected adult patients.
QuestionQuestion
QuestionQuestion
Question
Is antibiotic therapy effective as the first choice
for treating acute appendicitis in adults?
Major findings of the studyMajor findings of the study
Major findings of the studyMajor findings of the study
Major findings of the study
It was a prospective, not fully randomized study
in three hospitals in Sweden that included all adult patients
(> 18 years) with probable diagnosis of appendicitis (clinical
diagnosis with or without laboratory confirmation, ultrasound
or CT). The patients were divided into three groups:
reference (patients operated in Ostra Hospital), antibiotic
therapy or surgery. Surgery could be open or laparoscopic
surgery, while antibiotic therapy began with intravenous
cefotaxime and metronidazole for the first 24 hours,
followed by oral ciprofloxacin and metronidazole for a total
of 10 days. Patients received a questionnaire one and 12
months later and, if they did not answer it, they were
contacted by telephone. The study had two main outcomes:
efficacy and serious complications. The definition of efficacy
changed according to the group: for antibiotic therapy it
was defined as “no need of operation”; and for the surgical
group, the confirmation that “the diagnosis of appendicitis
was correct or there was an illness that required operation.”
The authors evaluated several secondary outcomes,
including cost.
This study included 369 patients, 202 in the
antibiotic group and 167 in the surgery one. Only 52% of
patients assigned to antibiotic treatment were non-
operatively treated, while 96% of allocated to surgery group
were operated. The groups were similar regarding gender,
age, levels of C-reactive protein, white blood cell count,
body temperature and the presence of local peritonitis. Only
11 of 119 patients treated with antibiotics had to be
operated, resulting in an efficiency of 90.8% for antibiotic
therapy. For appendectomy, efficacy was 89.2% (correct
diagnosis of appendicitis or other surgical pathology). Of
the 108 non-operated patients, 15 had recurrent appendicitis
(13.9%) within one year. One third of the recurrences
occurred within the first 10 days and 2/3 between 3 and 16
months after hospital discharge. Minor complications were
similar between groups. Major complications were three
times more frequent in patients undergoing surgical
treatment (p <0.05). Mild complications were similar in
both groups, but total costs were higher in operated
patients.
StrengthsStrengths
StrengthsStrengths
Strengths
• The study can be considered as generalizable,
as it included all adult patients with probable diagnosis of
acute appendicitis; a prospective study design allows better
evaluation of outcomes and data collection; major
complications were analyzed: reoperation, abscess, intestinal
obstruction, suture dehiscence, hernias and serious problems
of anesthesia; it reports diagnostic findings associated with
complicated forms of appendicitis. Phlegmon and
gangrenous appendicitis are associated with leukocytosis,
while perforated appendicitis is associated with elevated
C-reactive protein, leukocytosis and elevated body
temperature (p <0.001). This information can be used to
assist doctors in the early identification of patients who
develop complications; it evaluated complications according
to the technique applied. Surgical complications were similar
in open and laparoscopic surgery; it assesses outcomes
related to the well being of the patient. Patients treated
with antibiotics had abdominal pain for a longer time than
the control group.
LimitationsLimitations
LimitationsLimitations
Limitations
• The study was not completely randomized, as
the inclusion of patients in a given study group was made
according to their date of birth, and once determined, the
doctors in charge could follow or not the randomization
rules. Due to the inability to mask the interventions of the
study, this may introduce a bias in the randomization of
certain patients;
• A high rate of exchange at randomization. Of
the 202 patients assigned to antibiotic therapy, almost half
(96 patients or 48%) underwent surgery, which reduces
the ability of the study to demonstrate a positive effect of
this intervention if this effect actually exists. Moreover, this
exchange of randomization may indicate a failure in the
study inclusion criteria, or even a real problem with the
study design itself;
• There was a high rate of loss of follow-up of
patients to evaluate the outcomes of the study. Half the
patients were followed for 12 months. This always leaves a
question about the outcome of interventions in patients
who did not complete follow-up;
• It includes both uncomplicated and complicated
appendicitis and did not exclude phlegmon, which is non-
operatively treated by many surgeons;
• One cannot know for sure if the groups are
really similar. The two groups have different sizes (250 vs.
119) and the operated patients had more diffuse and
localized peritonitis; it is not possible to know with certainty
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the severity of patients in each group or how many actually
had appendicitis;
• Failure to consider the two patients who had a
cancer that was discovered only because of the operation;
• The population studied may not reflect the
reality of poor countries or those where the commitment to
long-term treatment (10 days) is small;
• It does not evaluate the pediatric population
(less than 18 years).
STUDY 2STUDY 2
STUDY 2STUDY 2
STUDY 2
Amoxicillin + clavulanic acid
versus
appendectomy for the treatment of non-complicated acute
appendicitis: a randomized, controlled, open and non-
inferior study
10
.
RationaleRationale
RationaleRationale
Rationale
Several studies have indicated antibiotic (ATB)
as treatment of acute appendicitis. However, due to
limitations of the methodological point of view, the studies
do not allow a definitive conclusion. Its objective was to
evaluate the use of amoxicillin + clavulanate
versus
appendectomy in adult patients with uncomplicated acute
appendicitis.
QuestionQuestion
QuestionQuestion
Question
Is the use of antibiotics for the treatment of acute
appendicitis as safe and effective as the surgical procedure?
Major findings of the studyMajor findings of the study
Major findings of the studyMajor findings of the study
Major findings of the study
The rate of peritonitis within 30 days was
significantly higher in the group treated with antibiotics. The
ATB group patients who underwent surgery had a higher
incidence of postoperative complications following a year.
StrengthsStrengths
StrengthsStrengths
Strengths
• Design of a prospective, randomized and
controlled study, what is important to reduce the possibility
of bias in the formation of study groups and try to evenly
distribute differences that may exist between patients in
both study groups. In fact, the group of appendectomy and
ATB are very similar in baseline characteristics evaluated;
well-defined inclusion criteria, diagnosis made by computed
tomography, including only cases of uncomplicated
appendicitis based on CT criteria; it assessed, as the main
outcome, a complication common to both treatments
(peritonitis); it found that the presence a fecalith is an
indicator of complicated appendicitis or failure of treatment
with antibiotics; carried out in a defined population, in the
case, in adults.
LimitationsLimitations
LimitationsLimitations
Limitations
• Non-inferiority margin of 10%, which can be
considered high;
• Comparison of the surgical group with two
different techniques (laparoscopic and open) where the
postoperative evolution may be different;
• Did not directly compare the subgroup of
patients assigned to ATB who were later operated with the
surgical group. The rate of complications was calculated
using the total number and not the number of patients
operated on the ATB group, resulting in a lower level of
morbidity;
• The cases operated on within 30 days due to
peritonitis in the ATB group and the ones without
perioperative confirmation of the diagnosis of acute
appendicitis were not considered in the sample for
comparison with the surgical group;
• The antibiotic mentioned in the introduction
(ertapenem) was not the antibiotic used in the study;
• Two different tomography devices were used
for the diagnosis of appendicitis;
• The socio-economic costs of each form of
treatment for the patient were not assessed;
• No blood cultures were performed for better
evaluation of the outcome of success or failure of antibiotic
treatment.
STUDIES 3 AND 4STUDIES 3 AND 4
STUDIES 3 AND 4STUDIES 3 AND 4
STUDIES 3 AND 4
• The exclusive use of antibiotics for the
treatment of uncomplicated acute appendicitis: a systematic
review and meta-analysis
7
.
• Appendectomy versus antibiotic treatment for
acute appendicitis. (Cochrane Review)
8
.
RationaleRationale
RationaleRationale
Rationale
Although the nonoperative treatment is already
a common practice in many centers in cases of appendicitis
complicated by intraperitoneal abscess, controversies remain
regarding the best approach for uncomplicated
appendicitis. Studies show inconsistent, and difficult to
interpret, results. Due to the high frequency of acute
appendicitis and the certainly big impact with the
widespread adoption of antibiotic therapy as first choice in
the treatment of the uncomplicated form, the review and
joint analysis of the best clinical trials on the topic is of
utmost importance. Two systematic reviews of the literature
of the last 30 years aimed at evaluating the evidence and
to determine the usefulness of antibiotic treatment in
relation to appendectomy for the treatment of acute
appendicitis.
QuestionQuestion
QuestionQuestion
Question
Liu and Fogg
7
: Is the nonoperative treatment
exclusively based on the use of antibiotics in uncomplicated
appendicitis effective? Is the nonoperative treatment
exclusively based on the use of antibiotics in uncomplicated
appendicitis safe?
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Wilms
et al
.
8
: Is the treatment with antibiotics
as effective as appendectomy (open or laparoscopic) in
healing within two weeks, without complications, for
patients with acute appendicitis evaluated up to one
year? This review considers an acceptable margin of 20%
for defining non-inferiority of antibiotic therapy.
Major findings of these studiesMajor findings of these studies
Major findings of these studiesMajor findings of these studies
Major findings of these studies
Both reviews evaluated four randomized clinical
trials in common. In these studies, Liu and Fogg
7
included
a retrospective scientific work of their own and the “quasi-
randomized” controlled clinical study of Hasson
et al
.
9
,
while Wilms
et al
.
8
included the study of Vons et al.
10
,
discussed earlier in this article, totaling 1444 patients in all
studies combined. Although evaluating virtually the same
studies, the two reviews reported distinct, and somewhat
contradictory, findings.
Liu and Fogg
7
observed that the early success
rate of exclusive antibiotic therapy ranged from 88.1% and
100% in the six studies included, with a late recurrence
rate of 5.3% to 14%, reaching 35% in one study. The
complication rate of clinical treatment was 0% in five of
the six included studies and ranged from 4.4% to 34% in
patients undergoing appendectomy. The authors concluded
that: 1 - Evidence suggests that nonoperative treatment is
effective and safe in patients with uncomplicated
appendicitis; 2 - Prospective, randomized, controlled trials
are needed to define the role of nonoperative treatment of
uncomplicated appendicitis.
Wilms
et al
.
8
reported that 73.4% (95% CI 62.7
to 81.9%) and 97.4% (95% CI 94.4 to 98.8%) of patients
treated with antibiotics and appendectomy, respectively,
were cured within two weeks and without significant
complications (including recurrence) up to a year. The
bottom 95% of the confidence interval of 15.2% was less
than the 20% acceptable to establish that the antibiotic is
non-inferior. Hospital stay was shorter in the appendectomy
group. No significant difference was observed for days off
due to illness, which was evaluated in only two
studies. Therefore, the authors concluded:
1 - Despite a lower rate of success in the antibiotic
group, the study is inconclusive, due to the CI that did not
reach the tolerated 20% level to declare that the treatment
is non-inferior;
2 - Due to the low quality of the studies, the
results should be interpreted cautiously and definitive
conclusions cannot be drawn from them;
3 - The appendectomy remains the standard
treatment for acute appendicitis; antibiotics can be used
exclusively in the context of research or in situations where
surgery is contraindicated.
StrengthsStrengths
StrengthsStrengths
Strengths
• Like any systematic review and meta-analysis,
a larger number of patients combined usually allows the
realization of a more definitive determination of the
effectiveness of treatment when compared to individual
studies; the review by Wilms
et al
.
8
follows the
recommendations of the Cochrane group, using a well-
established and rigorous scientific methodology, particularly
in relation to quality assessment of selected studies and
statistical analysis methods. This review has a primary
outcome that allows a meaningful comparison between
studies and treatments. The authors also evaluated factors
related to the implications for the patient and the costs of
the interventions; after a standardized and established
assessment of the quality of the selected studies, the authors
excluded the study by Hansson et al.
9
, rated as of poor
quality; the two studies conducted a detailed review of the
relevant literature, with inclusion criteria for studies clearly
explained.
LimitationsLimitations
LimitationsLimitations
Limitations
• Regardless of being well managed and of high
standard, any systematic review and meta-analysis
represents the quality of the studies combined. In the review
by Wilms
et al.
8
all selected studies were classified as of
low or moderate quality;
• The review of Liu and Fogg
7
considered all
studies as being of high quality. Nevertheless, the authors
used a rating scale (Newcastle-Ottawa Quality Assessment
Scale for Cohort Studies) suitable for studies that are not
randomized. Among the six studies included in this review,
four were randomized trials, one “partially randomized”
and only one retrospective, nonrandomized;
• The majority of studies included in the review
does not report the use of prophylactic antibiotics in patients
undergoing surgery, which is associated with a reduction
of surgical site infection. This may introduce a bias in favor
of surgical treatment;
• The studies do not provide information regarding
the number of patients initially approached for inclusion in
the scientific papers. This information is important to
evaluate patients’ opinion regarding the treatment studied. A
high number of patients not agreeing to participate in a
study of antibiotics for appendicitis suggests that this
treatment is not well accepted;
• In the study by Liu and Fogg
7
, although the
title suggests the conduction of a meta-analysis, it is really
just a systematic review of comparative studies;
• While four of the included studies are defined
as prospective and randomized, they lack information about
the inclusion criteria, type of randomization and other data
to better assess the level of evidence of all of them;
• The authors of the Cochrane systematic review
accepted an inferiority margin of up to 20% for the antibiotic
treatment in relation to appendectomy for the main
outcome of the study to consider it non-inferior
8
. In practical
terms, this would be the same as accepting that for every
five patients treated with antibiotics, one would not be cured
within two weeks or would had major complications within
one year of follow-up. Some surgeons certainly consider
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Rev. Col. Bras. Cir. 2012; 39(2): 159-163
this a very high risk for their patients;
• Apparently, some of these studies included
patients with localized or generalized peritonitis, which can
hardly be classified as uncomplicated appendicitis, and may
introduce an important selection bias;
• The methods of assessment and diagnosis of
appendicitis vary widely from study to study, making it very
difficult to assess the degree of evolution of appendicitis in
different groups.
CONCLUSION OF TBE-CITECONCLUSION OF TBE-CITE
CONCLUSION OF TBE-CITECONCLUSION OF TBE-CITE
CONCLUSION OF TBE-CITE
The conclusions are based on the publications
discussed above and the articles contained in these reviews.
There are some articles that suggest that the
medical treatment with antibiotics for acute appendicitis
display morbidity and mortality similar to, or higher than,
surgical treatment.
The methodological quality of studies comparing
antibiotic treatment with appendectomy is the most limiting
factor for more definitive conclusions on the topic.
There is no evidence of advantages or greater
efficacy in the treatment of acute appendicitis with
antibiotics, either in clinical and surgical terms or regarding
the socio-economic status of the patient.
The role of exclusive antibiotics in the treatment
of uncomplicated acute appendicitis in adults needs to be
better determined through better quality studies.
Treatment results in children were not assessed.
Recommendations of TBE-CiTE onRecommendations of TBE-CiTE on
Recommendations of TBE-CiTE onRecommendations of TBE-CiTE on
Recommendations of TBE-CiTE on
“Uncomplicated Acute Appendicitis in Adults:“Uncomplicated Acute Appendicitis in Adults:
“Uncomplicated Acute Appendicitis in Adults:“Uncomplicated Acute Appendicitis in Adults:
“Uncomplicated Acute Appendicitis in Adults:
Clinical or Surgical Treatment?”Clinical or Surgical Treatment?”
Clinical or Surgical Treatment?”Clinical or Surgical Treatment?”
Clinical or Surgical Treatment?”
1. The treatment of choice for uncomplicated
acute appendicitis in adults continues to be surgical;
2. The exclusive treatment with antibiotics cannot
be routinely recommended in current medical practice and
should only be considered in selected patients or in the
context of clinical studies.
REFERENCESREFERENCES
REFERENCESREFERENCES
REFERENCES
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analysis. Surgery. 2011;150(4):673-83.
8. Wilms IM, de Hoog DE, de Visser DC, Janzing HM. Appendectomy
versus antibiotic treatment for acute appendicitis. Cochrane
Database Syst Rev. 2011;9(11):CD008359.
9. Hansson J, Körner U, Khorram-Manesh A, Solberg A, Lundholm K.
Randomized clinical trial of antibiotic therapy versus
appendicectomy as primary treatment of acute appendicitis in
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10. Vons C, Barry C, Maitre S, Pautrat K, Leconte M, Costaglioli B, et
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Received on 28/02/2012
Accepted for publication 23/03/2012
Conflict of interest: none
Source of funding: none
DisclaimerDisclaimer
DisclaimerDisclaimer
Disclaimer: The recommendations and conclusions of this paper
represent the OPINION of the participants of the TBE-CiTE journal
meeting, and not necessarily the views of the institutions to which
they belong.
How to cite this article:How to cite this article:
How to cite this article:How to cite this article:
How to cite this article:
Hirano ES, Pereira BMT, Bustorff-Silva JM, Rizoli S, Nascimento Júnior
B, Fraga GP. Not complicated acute appendicitis in adults: clinical or
surgical treatment?. Rev Col Bras Cir. [periódico na internet] 2012;
39(2). Disponível em URL: http://www.scielo.br/rcbc
Address correspondence to:Address correspondence to:
Address correspondence to:Address correspondence to:
Address correspondence to:
Gustavo Pereira Fraga
Alexander Fleming Street, 181
University City “Professor. Zeferino Vaz “- Baron Gerard 13083-970 -
Campinas, SP
E-mail: fragagp2008@gmail.com
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