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Randomized clinical trial of antibiotic therapy for uncomplicated appendicitis. BJS 2017; 104: 1785-1790.

Published: 19th September 2017

Authors: H. C. Park, M. J. Kim, B. H. Lee

Background

Uncomplicated appendicitis may resolve spontaneously or require treatment with antibiotics or appendicectomy. The aim of this randomized trial was to compare the outcome of a non‐antibiotic management strategy with that of antibiotic therapy in uncomplicated appendicitis.

Method

Patients presenting to a university teaching hospital with CT‐verified uncomplicated simple appendicitis (appendiceal diameter no larger than 11 mm and without any signs of perforation) were randomized to management with a no‐antibiotic regimen with supportive care (intravenous fluids, analgesia and antipyretics as necessary) or a 4‐day course of antibiotics with supportive care. The primary endpoint was rate of total treatment failure, defined as initial treatment failure within 1 month and recurrence of appendicitis during the follow‐up period.

Results

Some 245 patients were randomized within the trial, and followed up for a median of 19 months. The duration of hospital stay was shorter (mean 3·1 versus 3·7 days; P < 0·001) and the medical costs lower (€1181 versus 1348; P < 0·001) among those randomized to therapy without antibiotics. There was no difference in total treatment failure rate between the groups: 29 of 124 (23·4 per cent) in the no‐antibiotic group and 25 of 121 (20·7 per cent) in the antibiotic group (P = 0·609). Eighteen patients (9 in each group) had initial treatment failure, 15 of whom underwent appendicectomy and three received additional antibiotics. Thirty‐six patients (20 in the no‐antibiotic group, 16 in the antibiotic group) experienced recurrence, of whom 30 underwent appendicectomy and six received further antibiotics.

Conclusion

Treatment failure rates in patients presenting with CT‐confirmed uncomplicated appendicitis appeared similar among those receiving supportive care with either a no‐antibiotic regimen or a 4‐day course of antibiotics. Registration number: KCT0000124 (
http://cris.nih.go.kr).

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1 Comment

BJS admin

1 month ago

We read with great interest the trial conducted by Park (1).

Few issues represent a matter of debate.

First concern is the external validity of a study where CT scan is used to identify the cut-off variables for patients having a high chance to be cured conservatively. This, if for some aspects allows a precise diagnosis, for some others forces us to reckon with the drawbacks of the extensive use of radiological investigations which expose the patients to risks of ionizing radiation exposure.

Moreover, routine use of CT in the Emergency Department in assessing right iliac fossa pain from suspected appendicitis may cause an unsustainable increase of the costs for public health care systems (2).

The second issue is the non-inferiority design of the trial. The sample size of the study was calculated based on an estimated total treatment failure rate of 20% with antibiotics. In our opinion, which probably also reflects that of the majority of patients with appendicitis, a 35% increase in failure rate for patients randomized to clinical observation is clinically unacceptable, especially if we think that surgery has an efficacy rate near to 100%.

Several studies demonstrated that non-operative treatment with or without antibiotics for patients affected by uncomplicated appendicitis is associated with a failure rate of 25% (3). Probably, the time has come to change our perspective and focus our scientific efforts towards the identification of those patients who might respond well to non-operative management through the establishment of multicenter databases and the development of multivariate analyses.

Mauro Podda
Chiara Gerardi
Salomone Di Saverio

Emergency and Trauma Surgery
Maggiore Hospital
Largo Nigrisoli, 2
40133 Bologna
Italy
salo75@inwind.it

References:
1. Park HC, Kim MJ, Lee BH. Randomized clinical trial of antibiotic therapy for uncomplicated appendicitis. Br J Surg 2017 Sep 19. doi: 10.1002/bjs.10660.
2. Di Saverio S, Birindelli A, Kelly MD, Catena F, Weber DG, Sartelli M, et al. WSES Jerusalem guidelines for diagnosis and treatment of acute appendicitis. World J Emerg Surg 2016 Jul 18. doi: 10.1186/s13017-016-0090-5.
3. Findlay JM, Kafsi JE, Hammer C, Gilmour J, Gillies RS, Maynard ND. Nonoperative management of appendicitis in adults: a systematic review and meta-analysis of randomized controlled trials. J Am Coll Surg 2016; 223: 814-824.