Antibiotic Therapy vs Appendectomy

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O R I G I N AL S C I E N T I FI C R E P O R T S A N D R E V I E W S

Antibiotic Therapy Versus Appendectomy for Acute Appendicitis:A Meta-Analysis

Krishna K. Varadhan David J. Humes

Keith R. Neal Dileep N. Lobo

Published online: 30 December 2009

SocieteInternationale de Chirurgie 2009

Abstract

Background Antibiotic treatment has been shown to beeffective in treating selected patients with acute appendi-

citis, and three randomized controlled trials (RCTs) have

compared the efficacy of antibiotic therapy alone with that

of surgery for acute appendicitis. The purpose of this meta-

analysis of RCTs was to assess the outcomes with these

two therapeutic modalities.

Methods All RCTs comparing antibiotic therapy alone

with surgery in patients over 18 years of age with sus-

pected acute appendicitis were included. Patients with

suspected perforated appendix or peritonitis, and those with

an allergy to antibiotics had been excluded in the RCTs.

The outcome measures studied were complications, length

of hospital stay, and readmissions.

Results Meta-analysis of RCTs of antibiotic therapy

versus surgery showed a trend toward a reduced risk of

complications in the antibiotic-treated group [RR (95%CI):

0.43 (0.16, 1.18) p = 0.10], without prolonging the length

of hospital stay [mean difference (inverse variance, ran-

dom, 95% CI): 0.11 (-0.22, 0.43) p =0.53]. Of the 350

patients randomized to the antibiotic group, 238 (68%)

were treated successfully with antibiotics alone and 38(15%) were readmitted. The remaining 112 (32%) patients

randomized to antibiotic therapy crossed over to surgery

for a variety of reasons. At 1 year, 200 patients in the

antibiotic group remained asymptomatic.

Conclusions This meta-analysis suggests that although

antibiotics may be used as primary treatment for selected

patients with suspected uncomplicated appendicitis, this is

unlikely to supersede appendectomy at present. Selection

bias and crossover to surgery in the RCTs suggest that

appendectomy is still the gold standard therapy for acute

appendicitis.

Introduction

Acute appendicitis is one of the commonest of surgical

emergencies, and appendectomy has become established as

the gold standard of therapy. However, as the diagnosis of

appendicitis in most countries is mainly a clinical one,

based on history and examination, diagnostic uncertainty in

patients with suspected appendicitis may lead to a delay in

treatment or negative surgical explorations, adding to the

morbidity associated with the condition [1].

Traditionally, patients with no overt diagnostic signs

such as right iliac fossa guarding or peritonism are moni-

tored for changes in clinical signs with or without having

been started on antibiotic therapy [2]. While antibiotics are

indicated in patients with signs of peritonism, their role in

the routine treatment of acute non-perforated appendicitis

is still debatable [3, 4]. Some studies have reported that

antibiotic therapy reduces wound and intra-abdominal

septic complications following surgery [5, 6]. Although

antibiotic therapy has been shown to be effective in treating

This article was presented at the Annual Conference of the Society for

Academic and Research Surgery, London, January 2010.

K. K. Varadhan D. J. Humes D. N. Lobo (&)

Division of Gastrointestinal Surgery, Nottingham Digestive

Diseases Centre NIHR Biomedical Research Unit, Nottingham

University Hospitals, Queens Medical Centre, Nottingham NG7

2UH, United Kingdom

e-mail: [email protected]

K. R. Neal

Department of Epidemiology and Public Health, and Nottingham

Digestive Diseases Centre NIHR Biomedical Research Unit,

Nottingham University Hospitals, Queens Medical Centre,

Nottingham NG7 2UH, United Kingdom

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DOI 10.1007/s00268-009-0343-5


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selected patients with suspected acute appendicitis, their

role in the primary treatment of the disease has not yet been

established clearly. Over the past two decades three ran-

domized clinical trials (RCTs) [79] have compared the

efficacy of antibiotic therapy alone with that of surgery for

acute appendicitis. The purpose of the present study was to

perform a meta-analysis of RCTs in order to assess the

outcomes with the two therapeutic modalities.

Methods

All RCTs in which patients over 18 years of age with

suspected acute appendicitis were randomized to antibiotic

therapy alone or surgery (appendectomy) at initial pre-

sentation were included. Patients with suspected perforated

appendix or peritonitis, and those with allergy to antibiotics

used in the protocols had been excluded in the RCTs.

The primary outcome measure of this meta-analysis was

complications, as described in the individual RCTs [79](major complications such as reoperation, abscess, small

bowel obstruction, wound rupture, wound hernia, deep vein

thrombosis, pulmonary embolism, postoperative cardiac

problems, and need for ileocecal resection, as well as minor

complications such as prolonged postoperative course,

bladder dysfunction, anesthesia-related complications,

diarrhea, Clostridium difficile infection, fungal infection,

and wound infection among others). Secondary outcome

measures included length of hospital stay and readmission

rates.

Search strategy

The Medline, Embase and Cochrane Library databases were

searched for RCTs comparing antibiotic therapy with sur-

gery for suspected acute appendicitis, published between

January 1966 and June 2009. The MESH terms, antibiotics,

surgery, appendicectomy, appendectomy, randomized

controlled trial, controlled clinical trial, randomized, pla-

cebo, drug therapy, randomly, trial, and groups were used in

combination with the Boolean operators AND, OR, and

NOT. The related article function was used to identify

other eligible studies for inclusion in the meta-analysis. The

search included publications in all languages.

Data collection and analysis

Two review authors (K.K.V. and K.R.N.) inspected the

citations identified from the search, and the retrieved arti-

cles were assessed according to the previously defined

criteria for inclusion in the meta-analysis. The data were

extracted from the included RCTs by the authors (K.K.V.

and K.R.N.) independently and integrated into the Review

Manager Version 5 software (The Nordic Cochrane Centre,

The Cochrane Collaboration, Copenhagen, Denmark) [10]

for analysis.

Statistical methods

The Review Manager Version 5 software was used to assess

the heterogeneity between studies by considering theI-squared method alongside the chi-square p value. A

random-effects model was used to analyze the differences

in outcome measures between the two groups, as this model

allows more flexibility in detecting between-patient differ-

ences (as some patients respond differently from others) and

reduces false positivity when compared with a fixed-effects

model [11]. Risk ratio was preferred to odds ratio, as the

latter is more appropriate for casecontrol studies [12].

Results

Characteristics of the studies included

Three RCTs [79] with a total of 661 patients were eligible

for inclusion in the meta-analysis (Fig.1). The character-

istics of the studies, as shown in Table1, were similar. The

studies included showed a moderate heterogeneity, and the

mean Jadad score [13] was 2.7. The methodological quality

of the studies is summarized in Table2.

Diagnosis of appendicitis

All patients were admitted with a history and clinical signs

of acute appendicitis with positive laboratory tests. Along

with raised inflammatory markers, positive findings at

ultrasonography formed part of the inclusion criteria in one

study where the patients had repeat ultrasound examina-

tions at days 10 and 30 during follow-up [ 9]. Computed

tomography and ultrasound scans were performed only in

some patients in the study by Hansson et al. [7], whereas,

imaging investigations were not mentioned in the study by

Styrud et al. [8].

The outcome measures commonly identified in the three

studies were treatment efficacy, diagnosis at operation,

complications, length of hospital stay, and readmission.

Time off work and patient experience of abdominal pain in

the first post-treatment year were also reported in these

studies.

Antibiotic group

The patients in the antibiotic group were treated with

intravenous antibiotics cefotaxime and metronidazole [7],

cefotaxime and tinidazole [8, 9], for a minimum of

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12 days, followed by oral antibiotics consisting of cipro-floxacin and metronidazole [7], ofloxacin and tinidazole

[8,9], for 810 days. In one study [7], antibiotic treatment

was continued beyond the initial course if there was no

clinical improvement. Patients with increasing abdominal

pain despite antibiotic therapy, or those who had signs of

perforation or peritonitis underwent surgery according to

protocol.

For the purpose of this meta-analysis, patients were

analyzed as being part of the antibiotic group when initial

randomization placed them in the antibiotic group and they

went onto have surgery, either for worsening symptoms

and signs during their primary admission or when they

were readmitted with suspicious signs of appendicitis.

Surgery group

In the study by Hansson et al. [7], after initial randomi-

zation 96 patients were transferred from the antibiotic

group to the surgery group, and 10 were transferred from

the surgery group to the antibiotic group. The histological

data were not listed separately for this group of patients in

this study, and subsequent analysis for outcome measuressuch as complications and length of stay was performed

both as intention to treat and per protocol. Therefore, the

diagnostic accuracy based on intention-to-treat analysis

cannot be ascertained. Moreover, we felt that, because of

inappropriate randomization, 32 patients who wanted

other therapy and those who withdrew from the study

should not have been included for further analysis. For

purpose of studying the outcome of antibiotic therapy, the

data are presented with or without these patients (Figs. 2

and3). However, we were unable to separate these patients

for meta-analysis of complication rates and length of stay.

In the other two studies [8,9], crossover to surgery only

happened after failed antibiotic therapy per protocol. These

patients (n = 16) were included for both intention to treat

and per protocol analysis, as illustrated in Fig. 4.

Patients randomized to surgery underwent either open or

laparoscopic appendectomy. Except for 3 patients who

were successfully treated with a second course of antibi-

otics, all patients who were readmitted with suspected

recurrent appendicitis following initial successful treatment

with antibiotics, underwent appendectomy.

Fig. 1 Selection of studies

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Summary of outcomes

Table3 illustrates the main outcome measures listed for

the two groups. All patients included in the studies had a

minimum follow-up for 1 year.

Antibiotic group

There were 350 patients randomized to the antibiotic group,

of whom 238 (65%) were treated successfully with antibi-

otics alone. Among those 238 patients, there were 38 (15%)

recurrences reported. Of the patients with recurrence, 3

were retreated successfully with antibiotics; the remaining

35 had appendicitis (25 phlegmonous, 9 perforated, and 1

gangrenous on histology after appendicectomy).

Of the 112 patients who crossed over from the antibiotic

group to the surgery group, histological diagnosis was

available for 26. In the crossover group, 23 of the 26

patients had histologically proven appendicitis (10 phleg-

monous, 10 perforated, and 3 gangrenous). The diagnosesin the remaining 3 patients were reported as normal, ter-

minal ileitis, or other. More significantly, 200 patients in

the antibiotic group remained asymptomatic at 1 year

(Fig.2).

Surgery group

There was no crossover from the surgery group to the

antibiotic group in trials by Styrud et al. [8] and Eriksson

et al. [9] In the study by Hansson et al. [7] 10 patients

changed from their assigned groups: 7 patients wanted

other therapy, 2 were allocation faults, and 1 patient was

too ill for an operation, as described in the article.

Of the 394 patients randomized to surgery, 357 were

treated successfully for histologically confirmed appendi-

citis (249 phlegmonous, 57 perforated, and 51 gangrenous).

Of the remaining patients, 23 had other diagnoses and 14

had normal appendices, as illustrated in Fig. 4.

Complications noted in the two groups are summarized

in Fig.5. Meta-analysis of RCTs showed a trend for a

reduced risk of complications for antibiotic therapy [RR

(95%CI): 0.43 (0.16, 1.18) P = 0.10] and no difference

between antibiotic therapy and surgery for length of hos-

pital stay [mean difference (inverse variance, random, 95%

CI): 0.11 (-0.22, 0.43) P = 0.53]. The results for com-

plication rates and length of hospital stay are summarized

in the Forest plots in Figs. 6 and 7, respectively.

Discussion

The results from this meta-analysis suggest that although

antibiotics may be used as primary treatment for selectedTable2

Qualityassessmentandstudydesign

RCT

No.ofpatients

Agegroups

Median

follow-up

(years)

Consecutive

seriesof

patients

Allocation

co

ncealment

Methodof

randomization

described&

appropriate

Blinding

Descriptionof

dropoutsand

withdrawals

Jadad

score

Antibiotic

therapy

S

urgery

Antibiotic

therapy

Surgery

Hanssonetal.[7]

202

1

67

Mean(standard

errorofmean)

Mean(standard

errorofmean)

1

Yes

No

Yes

Notblinded

Yes

3

38(1)

38(1)

Styrudetal.[8]

128

1

24

Range1850;

meannotreported

Range18

50;mean

notreported

1

Yes

No

Yes

Notblinded

No

2

Erikssonetal.[9]

20

2

0

Mean(range)

Mean(ran

ge)

1

Yes

No

Yes

Notblinded

Yes

3

27(1853)

35(1975

)

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Fig. 2 Outcome data for antibiotic therapy (intention to treat)

Fig. 3 Outcome data for antibiotic therapy (excluding inappropriate randomization)

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patients with suspected uncomplicated appendicitis, on

current evidence, this therapeutic approach is unlikely to

supersede appedectomy. Treatment with antibiotics resul-

ted in a trend toward reduced risk of complications [RR

(95%CI): 0.43 (0.16, 1.18) P = 0.10] without prolonging

the length of hospital stay [mean difference (inverse vari-

ance, random, 95%CI): 0.11 (-0.22, 0.43) P =0.53],

when compared with appendectomy. However, only 68%

patients were treated successfully with antibiotics in their

primary admission, with a 15% readmission rate. Antibi-

otic therapy was not associated with increased morbidity

through readmissions, as reflected by similar histological

results in these patients to those who had surgery during

their primary admission. It should be emphasized that 42%

of patients initially treated with antibiotics required surgi-

cal intervention either at initial admission or at readmis-

sion. Therefore, these results have to be interpreted more

carefully in the clinical context, as the conclusions of this

meta-analysis are limited by the study design, relatively

high cross-over rate from the antibiotic to the surgery

group, methodological quality, and definitions of primary

endpoints such as treatment efficacy, recurrence, and

complication rates in the included RCTs. Paucity of spe-

cific data for patients who crossed over to surgery further

limits the validity of the conclusions.

The diagnosis of acute appendicitis in the included RCTs

was largely based on history, clinical examination, and

laboratory findings, combined with some imaging tests

where necessary. As there was no common standardized

protocol for diagnosing appendicitis in these studies, some

patients treated in the antibiotic group may not have had

appendicitis, and therefore the classification does not nec-

essarily reflect the true treatment efficacy of antibiotic

therapy. Furthermore the crossover of patients to the sur-

gery group following their initial randomization to antibi-

otic therapy would result in unidentified bias in reporting

complication rates in the surgery group. Moreover, although

the readmissions following antibiotic therapy were pre-

sumed to be due to recurrent appendicitis and were treated

by appendectomy, the reported readmissions in the surgery

group were mainly for surgery-related reasons. Therefore

a direct comparison of recurrence rates or morbidity

between the groups has to be interpreted with caution.

A negative appendectomy rate as high as 1525% has

been reported in the literature with the inherent risk of

increased complications and morbidity [14,15]. However,

a retrospective study of 199 patients in our institution

showed no statistically significant difference in the com-

plication rates following surgery, between inflamed and

non-inflamed appendicitis, although it showed increased

septic complications in the inflamed group [1].

Reported recurrence rates following conservative treat-

ment of acute appendicitis range between 3 and 25%, and

the complication rate following interval appendectomy

varies from 8 to 23% [16]. However, a retrospective study

of 60 patients who were initially treated conservatively for

appendicitis confirmed on the basis of ultrasound findings

obtained at admission and follow-up, showed a recurrence

rate of 38% [17], whereas the results of the present meta-

analysis show a readmission rate of 15% following anti-

biotic therapy. The treatment of acute appendicitis with

antibiotics may result in failure to diagnose neuroimmune

appendicitis [18,19]. Failure to treat these patients with an

appendectomy may lead to development of chronic right

iliac fossa pain, but it should be emphasised that this was

not an apparent problem in any of the RCTs.

Fig. 4 Outcome data for

patients undergoing

appendectomy

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Table3

Summaryofoutcomes

Study

No.ofpatients

Treatmentefficacyn

(%)

Complicationsn

Recurrencesn

Lengtho

fstay(days)Mean

(SD)

Positivediagnosisatoperation

AntibioticsSu

rgeryAntibiotics

Surgery

Antibiotic

sSurgeryAntibioticsSurgeryAntibiotics

Surgery

Antibiotics

Surgery

Hanssonetal.[7]202

16

7

97(48)

142(85)

51

55

15

0

3(0.1)

3(0.2)

21(9?

12)

220(128

phlegmonous,42

gangrenous,50

perforated)(3

othersurgically

treatablecauses)

9inprimary

admission:3

phlegmonous;3

gangrenous,3

perforated

12of15recurrences

hadappendectom

y;

8phlegmonous,1

gangrenous,3

perforated.(3

treatedwith

antibiotics)

Styrudetal.[8]

128

12

4

113(88)

120(96)

4

17

16

0

3.0(1.4)

2.6(1.2)

31(15primary?

16

readmissions;1

primaryhad

terminalileitis)

120

Erikssonetal.[9]

20

2

0

19(95)

17(85)

0

2

7

0

3.1(0.3)

3.4(1.9)

8(1primary?

7

readmissions)

17

Total

350

31

1

240

360

29

104

38

0

60/63

357/394

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Another risk of antibiotic therapy in women of

childbearing age is tubal infertility, which has been

reported between 3.2 and 4.8% [2022]. In addition,

other diagnoses may be missed, especially in the elderly.

Although the routine use of imaging modalities including

ultrasound or CT in patients with suspected acute

appendicitis is not recommended [23, 24], many studies

support selective use of imaging techniques by body

imaging radiologists with improved diagnostic criteria

[2527]. In this context, the diagnostic value of lapa-

roscopy with its advantages of reduced risk of postop-

erative ileus and wound infection in this group of

Fig. 5 Complications

Fig. 6 Forest plot of comparison: complications (M-H = Mantel-Haenszel test)

Fig. 7 Forest plot of comparison: length of stay (IV = inverse variance)

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patients has been proven to be more useful in some

studies [2830]. It should, therefore, be considered in

patients in whom the diagnosis is uncertain or in those

who present with recurrent right iliac fossa pain.

Conclusions

From this meta-analysis of RCTs, there is evidence to

support the safe use of antibiotic therapy alone in selected

patients presenting with acute appendicitis where perfora-

tion or peritonitis is not suspected. Antibiotic therapy is

associated with a 68% success rate and a trend toward

decreased risk of complications without prolonging hos-

pital stay. However, the conclusions of this meta-analysis

are limited by the study design, the high crossover rate

from the antibiotic to the surgery group, methodological

quality, and definitions of primary endpoints such as

treatment efficacy, recurrence, and complication rates in

the included RCTs. It should, therefore, be stressed that atpresent appendectomy remains the gold standard for the

treatment of acute appendicitis. Before antibiotic therapy

can replace surgery for uncomplicated appendicitis, further

studies with clear inclusion and diagnostic criteria (e.g.,

randomization after appendicitis has been proven on CT

scan) are needed to study the effects of antibiotic therapy as

the first-line treatment for uncomplicated appendicitis.

Reporting of outcome should be on an intention-to-treat

basis rather than a per-protocol basis in order to determine

the true efficacy of the treatment.

Acknowledgments This work was supported in part by a ResearchFellowship (K.K.V.) from the Nottingham Digestive Diseases Centre

NIHR Biomedical Research Unit, Nottingham, UK.

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