World J Surg (2010) 34:199–209 DOI 10.

1007/s00268-009-0343-5

ORIGINAL SCIENTIFIC REPORTS AND REVIEWS

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 ´ te ´ Internationale de Chirurgie 2009 Ó Socie

Abstract Background Antibiotic treatment has been shown to be effective in treating selected patients with acute appendicitis, 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 metaanalysis 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 suspected 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, random, 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 monitored 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 Á D. J. Humes Á D. N. Lobo (&) Division of Gastrointestinal Surgery, Nottingham Digestive Diseases Centre NIHR Biomedical Research Unit, Nottingham University Hospitals, Queen’s Medical Centre, Nottingham NG7 2UH, United Kingdom e-mail: dileep.lobo@nottingham.ac.uk K. R. Neal Department of Epidemiology and Public Health, and Nottingham Digestive Diseases Centre NIHR Biomedical Research Unit, Nottingham University Hospitals, Queen’s Medical Centre, Nottingham NG7 2UH, United Kingdom

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and need for ileocecal resection. The data were extracted from the included RCTs by the authors (K. randomized controlled trial. trial. and the retrieved articles were assessed according to the previously defined criteria for inclusion in the meta-analysis. antibiotics.7.R. surgery. 1). Along with raised inflammatory markers. diarrhea. positive findings at ultrasonography formed part of the inclusion criteria in one study where the patients had repeat ultrasound examinations at days 10 and 30 during follow-up [9]. and K. randomly. Diagnosis of appendicitis All patients were admitted with a history and clinical signs of acute appendicitis with positive laboratory tests. their role in the primary treatment of the disease has not yet been established clearly. as well as minor complications such as prolonged postoperative course.N. for a minimum of 123 . anesthesia-related complications. pulmonary embolism. [8]. Clostridium difficile infection. The search included publications in all languages.K. Data collection and analysis Two review authors (K.N. Manager Version 5 software (The Nordic Cochrane Centre. as shown in Table 1. The characteristics of the studies. Embase and Cochrane Library databases were searched for RCTs comparing antibiotic therapy with surgery for suspected acute appendicitis. A random-effects model was used to analyze the differences in outcome measures between the two groups.V. and groups were used in combination with the Boolean operators AND.) independently and integrated into the Review Results Characteristics of the studies included Three RCTs [7–9] with a total of 661 patients were eligible for inclusion in the meta-analysis (Fig. Over the past two decades three randomized clinical trials (RCTs) [7–9] have compared the efficacy of antibiotic therapy alone with that of surgery for acute appendicitis. The primary outcome measure of this meta-analysis was complications. appendicectomy. controlled clinical trial. published between January 1966 and June 2009. imaging investigations were not mentioned in the study by Styrud et al. Risk ratio was preferred to odds ratio. complications. Secondary outcome measures included length of hospital stay and readmission rates. were similar.) inspected the citations identified from the search. and K. Computed tomography and ultrasound scans were performed only in some patients in the study by Hansson et al. The ‘‘related article’’ function was used to identify other eligible studies for inclusion in the meta-analysis. wound rupture. Denmark) [10] for analysis. bladder dysfunction. Antibiotic group The patients in the antibiotic group were treated with intravenous antibiotics cefotaxime and metronidazole [7]. 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 presentation were included. abscess. OR. deep vein thrombosis. diagnosis at operation.V. fungal infection. placebo. randomized. length of hospital stay. 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. Patients with suspected perforated appendix or peritonitis. wound hernia. Time off work and patient experience of abdominal pain in the first post-treatment year were also reported in these studies.K. The methodological quality of the studies is summarized in Table 2. [7]. and readmission. Search strategy The Medline. The MESH terms. postoperative cardiac problems. as described in the individual RCTs [7–9] (major complications such as reoperation. cefotaxime and tinidazole [8. as the latter is more appropriate for case–control studies [12]. drug therapy. and the mean Jadad score [13] was 2. The outcome measures commonly identified in the three studies were treatment efficacy. appendectomy. and wound infection among others). small bowel obstruction. The studies included showed a moderate heterogeneity. and those with allergy to antibiotics used in the protocols had been excluded in the RCTs. 9]. whereas. and NOT. The Cochrane Collaboration. Copenhagen.R. as this model allows more flexibility in detecting between-patient differences (as some patients respond differently from others) and reduces false positivity when compared with a fixed-effects model [11].200 World J Surg (2010) 34:199–209 selected patients with suspected acute appendicitis. Statistical methods The Review Manager Version 5 software was used to assess the heterogeneity between studies by considering the ‘‘I-squared’’ method alongside the chi-square p value.

However. and subsequent analysis for outcome measures such as complications and length of stay was performed both as intention to treat and per protocol. antibiotic treatment was continued beyond the initial course if there was no clinical improvement. we felt that. underwent appendectomy. we were unable to separate these patients for meta-analysis of complication rates and length of stay. In the other two studies [8. for 8–10 days. 2 and 3). followed by oral antibiotics consisting of ciprofloxacin and metronidazole [7]. Moreover. These patients (n = 16) were included for both intention to treat and per protocol analysis. ofloxacin and tinidazole [8. [7]. Patients with increasing abdominal pain despite antibiotic therapy. For the purpose of this meta-analysis. Patients randomized to surgery underwent either open or laparoscopic appendectomy. because of inappropriate randomization. crossover to surgery only happened after failed antibiotic therapy per protocol. 9]. 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. Except for 3 patients who were successfully treated with a second course of antibiotics. after initial randomization 96 patients were transferred from the antibiotic group to the surgery group. the data are presented with or without these patients (Figs. 32 patients ‘‘who wanted other therapy’’ and those ‘‘who withdrew from the study’’ should not have been included for further analysis. all patients who were readmitted with suspected recurrent appendicitis following initial successful treatment with antibiotics. For purpose of studying the outcome of antibiotic therapy. the diagnostic accuracy based on intention-to-treat analysis cannot be ascertained. 9]. The histological data were not listed separately for this group of patients in this study. 1 Selection of studies 201 1–2 days.World J Surg (2010) 34:199–209 Fig. either for worsening symptoms and signs during their primary admission or when they were readmitted with suspicious signs of appendicitis. Therefore. as illustrated in Fig. 4. 123 . and 10 were transferred from the surgery group to the antibiotic group. Surgery group In the study by Hansson et al. or those who had signs of perforation or peritonitis underwent surgery according to protocol. In one study [7].

Questionnaire was sent to all patients after 1 and 12 months. 6 weeks. All removed appendixes were sent for histology Outcomes Hospital stay. recurrences. computed tomography. appendectomy was performed. CRP—to identify patients with a high probability of acute appendicitis Participants Patients with typical history and clinical signs. admitted to six different hospitals between 1996 and 1999. Stools examined for Clostridium difficile toxin at day 30. Allocation by date of birth (odd number—antibiotics group. hospital stay. Patients were monitored at the end of 1 week. Ultrasonography and laboratory tests—WBC. Patients were excluded from the study in the event of increased abdominal pain and generalized peritonitis leading to surgery Surgery: Treated with antibiotics only in the event of perforation or for 24 h in cases of abdominal spillage. length of antibiotic therapy. positive diagnosis at surgery. subsequent data were discounted Interventions Conservative: Cefotaxime 2 g 12 hourly and tinidazole for 2 days. and 1 year Participants Male patients. recurrences. and blood tests for WBC and CRP were taken. Discharged after 2 days with oral ofloxacin 200 mg twice daily and tinidazole 500 mg twice daily for 8 days. wound infection. Discharged when conditions were satisfactory and when patients wished to return home. and underwent surgery. complications. and those who agreed were subsequently randomized either to surgery or antibiotic therapy. and sick leave. Pain was registered every 6 h on a visual analogue scale (VAS). WBC. pain scores (VAS) and body temperature were recorded. 10. and oral temperature was measured twice daily. and 30 days after admission. recurrent appendicitis . If symptoms had not improved within first 24 h. If no improvement. positive findings at ultrasound (US). Initial randomization of 20 patients in each group. Abdominal and rectal examination on days 6 and 10.dose antibiotic prophylaxis. Patients when improved were discharged 24 h later with oral ciprofloxacin 500 mg twice a day and metronidazole 400 mg three times a day for 10 days. morphine consumption. even number—surgery group). laboratory tests. and postoperative antibiotic treatment when the appendix was gangrenous or perforated All specimens were sent for histological examination Outcomes Treatment efficacy.202 123 Table 1 Characteristics of studies in the meta-analysis Study of Hansson et al. and body temperature. abdominal pain after discharge from hospital. Telephoned if no response Participants 369 patients with positive history. All conservatively treated patients with a suspected recurrence of appendicitis underwent surgery Surgery: Patients randomized to surgery were operated open or laparoscopically at the surgeon’s discretion. The total costs for the primary hospital stay were analyzed for each patient Study of Styrud et al. diagnosis at operation. [7] Methods Randomized controlled trial. and either increased WBC and CRP values or high CRP or WBC levels on two occasions within a 4-h interval. and reoperations. ultrasonography. Pain was recorded on VAS every 6 h and oral temperature was measured twice daily. Discharged after 2 days with oral ofloxacin 200 mg twice daily and tinidazole 500 mg twice daily for 10 days. open or laparoscopic technique. [9] Methods Randomization of patients admitted with history and clinical signs of acute appendicitis. Patients with suspected appendicitis with a C-reactive protein (CRP) level [ 10 mg/l in whom perforation was not suspected were asked to participate in the study Interventions Antibiotics: Intravenous cefotaxime 2 g 12 hourly and tinidazole 800 mg daily for 2 days. one hospital used only as a reference cohort for comparison with study and control groups at the other two hospitals. clinical signs. No women were enrolled by decision of the local ethics committee. [8] Methods Patients were asked to participate if appendectomy was planned. and gynecological examination Interventions Antibiotics: intravenous (IV) cefotaxime 1 g twice daily and metronidazole for at least 24 h. complications Study of Eriksson et al. US performed on days 10 and 30 World J Surg (2010) 34:199–209 Outcomes Pain scores. but one patient from the antibiotic group developed increased abdominal pain and generalized peritonitis. IV treatment was prolonged Surgery: Appendectomy was performed according to the author’s usual practice: single. 18–50 years of age. All specimens were sent for histology Follow-up: All patients were seen 6. sick leave. Three hospitals included for the study. length of hospital stay. and in some cases.

and 1 patient was ‘‘too ill for an operation. 357 were treated successfully for histologically confirmed appendicitis (249 phlegmonous. Complications noted in the two groups are summarized in Fig. Of the remaining patients. as illustrated in Fig. and 51 gangrenous).18) P = 0. and 1 gangrenous on histology after appendicectomy).53]. [8] and Eriksson et al. and 3 gangrenous). Yes No Yes Antibiotic group There were 350 patients randomized to the antibiotic group. 1. The diagnoses in the remaining 3 patients were reported as normal. of whom 238 (65%) were treated successfully with antibiotics alone. mean not reported 124 128 Styrud et al. [9] 20 20 Age groups Mean (standard error of mean) Surgery No. Among those 238 patients. the remaining 35 had appendicitis (25 phlegmonous.43) P = 0. 95% CI): 0. [7] 10 patients changed from their assigned groups: 7 patients wanted other therapy.43 (0. there were 38 (15%) recurrences reported. 2).10] and no difference between antibiotic therapy and surgery for length of hospital stay [mean difference (inverse variance. 38 (1) Range 18–50.’’ as described in the article. Surgery group Not blinded Method of randomization described & appropriate Blinding Not blinded Yes No Yes 1 Allocation concealment Yes Consecutive series of patients No Median follow-up (years) Yes 1 1 Yes No Yes Not blinded Table 2 Quality assessment and study design There was no crossover from the surgery group to the antibiotic group in trials by Styrud et al. [9] In the study by Hansson et al. respectively.16. terminal ileitis. 0. 57 perforated. 3 were retreated successfully with antibiotics. In the crossover group. The results for complication rates and length of hospital stay are summarized in the Forest plots in Figs. Of the patients with recurrence.World J Surg (2010) 34:199–209 Jadad score 203 Summary of outcomes 3 2 3 Description of dropouts and withdrawals Table 3 illustrates the main outcome measures listed for the two groups. mean not reported 38 (1) Range 18–50. 5. 9 perforated. 4. Of the 112 patients who crossed over from the antibiotic group to the surgery group. histological diagnosis was available for 26. random. of patients Antibiotic therapy Hansson et al. Meta-analysis of RCTs showed a trend for a reduced risk of complications for antibiotic therapy [RR (95%CI): 0. 23 of the 26 patients had histologically proven appendicitis (10 phlegmonous. 6 and 7. 10 perforated. 2 were allocation faults. 200 patients in the antibiotic group remained asymptomatic at 1 year (Fig.11 (-0. All patients included in the studies had a minimum follow-up for 1 year. [8] Mean (standard error of mean) Mean (range) Mean (range) Eriksson et al. or ‘‘other. [7] 202 167 27 (18–53) Antibiotic therapy 35 (19–75) Surgery Discussion The results from this meta-analysis suggest that although antibiotics may be used as primary treatment for selected RCT 123 . Of the 394 patients randomized to surgery. 23 had other diagnoses and 14 had normal appendices.’’ More significantly.22.

2 Outcome data for antibiotic therapy (intention to treat) Fig. 3 Outcome data for antibiotic therapy (excluding inappropriate randomization) 123 .204 World J Surg (2010) 34:199–209 Fig.

and therefore the classification does not necessarily reflect the true treatment efficacy of antibiotic therapy. clinical examination. but it should be emphasised that this was not an apparent problem in any of the RCTs. However. 95%CI): 0.World J Surg (2010) 34:199–209 Fig. and the complication rate following interval appendectomy varies from 8 to 23% [16]. Paucity of specific data for patients who crossed over to surgery further limits the validity of the conclusions. 19]. and complication rates in the included RCTs.22. Furthermore the crossover of patients to the surgery group following their initial randomization to antibiotic therapy would result in unidentified bias in reporting complication rates in the surgery group. Treatment with antibiotics resulted in a trend toward reduced risk of complications [RR (95%CI): 0. this therapeutic approach is unlikely to supersede appedectomy. these results have to be interpreted more carefully in the clinical context. 123 .53]. Reported recurrence rates following conservative treatment of acute appendicitis range between 3 and 25%.16. and laboratory findings. although the readmissions following antibiotic therapy were presumed to be due to recurrent appendicitis and were treated by appendectomy. random. A negative appendectomy rate as high as 15–25% has been reported in the literature with the inherent risk of increased complications and morbidity [14. only 68% patients were treated successfully with antibiotics in their primary admission. with a 15% readmission rate. when compared with appendectomy. the reported readmissions in the surgery group were mainly for ‘‘surgery-related’’ reasons. methodological quality. Antibiotic therapy was not associated with increased morbidity through readmissions.43) P = 0. The diagnosis of acute appendicitis in the included RCTs was largely based on history. as reflected by similar histological results in these patients to those who had surgery during their primary admission. Therefore. some patients treated in the antibiotic group may not have had appendicitis. Therefore a direct comparison of recurrence rates or morbidity between the groups has to be interpreted with caution. as the conclusions of this meta-analysis are limited by the study design. Failure to treat these patients with an appendectomy may lead to development of chronic right iliac fossa pain.18) P = 0. Moreover. and definitions of primary endpoints such as treatment efficacy.11 (-0. 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. on current evidence. However. 1. a retrospective study of 199 patients in our institution showed no statistically significant difference in the complication rates following surgery. However. The treatment of acute appendicitis with antibiotics may result in failure to diagnose neuroimmune appendicitis [18.43 (0. As there was no common standardized protocol for diagnosing appendicitis in these studies. relatively high cross-over rate from the antibiotic to the surgery group. whereas the results of the present metaanalysis show a readmission rate of 15% following antibiotic therapy. although it showed increased septic complications in the inflamed group [1]. 4 Outcome data for patients undergoing appendectomy 205 patients with suspected uncomplicated appendicitis.10] without prolonging the length of hospital stay [mean difference (inverse variance. combined with some imaging tests where necessary. It should be emphasized that 42% of patients initially treated with antibiotics required surgical intervention either at initial admission or at readmission. between inflamed and non-inflamed appendicitis. 0. recurrence. 15]. showed a recurrence rate of 38% [17].

9) 8 (1 primary ? 7 readmissions) 60/63 120 Complications n Recurrences n Length of stay (days) Mean (SD) Positive diagnosis at operation Surgery 220 (128 phlegmonous.3) 3. 3– perforated.2) 31 (15 primary ? 16 readmissions. [9] 20 20 Total 350 311 World J Surg (2010) 34:199–209 . 50 perforated) (3 other surgically treatable causes) 97 (48) 19 (95) 240 360 29 104 17 (85) 0 2 7 17 357/394 Table 3 Summary of outcomes Study No.2) Antibiotics Surgery Antibiotics Surgery Antibiotics Surgery Antibiotics 21 (9 ? 12) 9 in primary admission: 3 phlegmonous. 42 gangrenous. 8 phlegmonous.1) 3 (0. 1 gangrenous. [8] 128 124 Eriksson et al. 3 perforated 12 of 15 recurrences had appendectomy. (3– treated with antibiotics) 113 (88) 120 (96) 4 17 16 0 3.4 (1. [7] 202 167 Styrud et al. 1– primary had terminal ileitis) 0 38 0 3. of patients Antibiotics Surgery Antibiotics Hansson et al.4) 2.206 123 Treatment efficacy n (%) Surgery 142 (85) 51 55 15 0 3 (0.1 (0.6 (1. 3 gangrenous.0 (1.

In addition. especially in the elderly.8% [20–22]. which has been reported between 3. the diagnostic value of laparoscopy with its advantages of reduced risk of postoperative ileus and wound infection in this group of 123 .2 and 4. Although the routine use of imaging modalities including ultrasound or CT in patients with suspected acute appendicitis is not recommended [23. 24].World J Surg (2010) 34:199–209 Fig. 5 Complications 207 Fig. other diagnoses may be missed. many studies support selective use of imaging techniques by body imaging radiologists with improved diagnostic criteria [25–27]. 7 Forest plot of comparison: length of stay (IV = inverse variance) Another risk of antibiotic therapy in women of childbearing age is tubal infertility. 6 Forest plot of comparison: complications (M-H = Mantel-Haenszel test) Fig. In this context.

However. Bhende S. Daling JR. Horikoshi H (2009) Prospective examination of patients suspected of having appendicitis using new computed tomography criteria including ‘‘maximum depth of intraluminal appendiceal fluid greater than 2. Andersen BR. 8. 26. Korner U. Arch Surg 137:799–804 discussion 804 Humes DJ. there is evidence to support the safe use of antibiotic therapy alone in selected patients presenting with acute appendicitis where perforation or peritonitis is not suspected. 18. and definitions of primary endpoints such as treatment efficacy. and in neurogenic appendicopathy. Ohya N. Koepsell T (2002) The clinical and economic correlates of misdiagnosed appendicitis: nationwide analysis. Bohner H. It should. Wong SK et al (2005) Optimum duration of prophylactic antibiotics in acute non-perforated appendicitis. Gerharz CD. Arch Surg 118:651–655 6. Moore DE et al (1986) Appendectomy and the risk of tubal infertility. therefore. 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