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The NOTA Study (Non Operative Treatment for Acute Appendicitis): Prospective Study on the Efficacy and Safety of Antibiotics (Amoxicillin and Clavulanic Acid) for Treating Patients With Right Lower Quadrant Abdominal Pain and Long-Term Follow-up of Conservatively Treated Suspected Appendicitis

Di Saverio, Salomone MD*; Sibilio, Andrea MD*; Giorgini, Eleonora MD*; Biscardi, Andrea MD*; Villani, Silvia MD*; Coccolini, Federico MD; Smerieri, Nazareno MD*; Pisano, Michele MD; Ansaloni, Luca MD; Sartelli, Massimo; Catena, Fausto MD, PhD, FRCS§; Tugnoli, Gregorio MD*

doi: 10.1097/SLA.0000000000000560
Original Articles

Objectives: To assess the safety and efficacy of antibiotics treatment for suspected acute uncomplicated appendicitis and to monitor the long term follow-up of non-operated patients.

Background: Right lower quadrant abdominal pain is a common cause of emergency department admission. The natural history of acute appendicitis nonoperatively treated with antibiotics remains unclear.

Methods: In 2010, a total of 159 patients [mean AIR (Appendicitis Inflammatory Response) score = 4.9 and mean Alvarado score = 5.2] with suspected appendicitis were enrolled and underwent nonoperative management (NOM) with amoxicillin/clavulanate. The follow-up period was 2 years.

Results: Short-term (7 days) NOM failure rate was 11.9%. All patients with initial failures were operated within 7 days. At 15 days, no recurrences were recorded. After 2 years, the overall recurrence rate was 13.8% (22/159); 14 of 22 patients were successfully treated with further cycle of amoxicillin/clavulanate. No major side effects occurred. Abdominal pain assessed by the Numeric Rating Scale and the visual analog scale; median Numeric Rating Scale score was 3 at 5 days and 2 after 7 days. Mean length of stay of nonoperatively managed patients was 0.4 days, and mean sick leave period was 5.8 days. Long-term efficacy of NOM treatment was 83% (118 patients recurrence free and 14 patients with recurrence nonoperatively managed). None of the single factors forming the Alvarado or AIR score were independent predictors of failure of NOM or long-term recurrence. Alvarado and AIR scores were the only independent predictive factors of NOM failure after multivariate analysis, but both did not correlate with recurrences. Overall costs of NOM and antibiotics were €316.20 per patient.

Conclusions: Antibiotics for suspected acute appendicitis are safe and effective and may avoid unnecessary appendectomy, reducing operation rate, surgical risks, and overall costs. After 2 years of follow-up, recurrences of nonoperatively treated right lower quadrant abdominal pain are less than 14% and may be safely and effectively treated with further antibiotics.

Lower abdominal pain and suspected appendicitis are one of the most common causes of emergency department admission, and acute appendicitis is the most common surgical emergency. In 2010, a total of 159 patients with suspected appendicitis were enrolled for nonoperative management with amoxicillin/clavulanate. All patients were assessed for Alvarado and AIR (Appendicitis Inflammatory Response) scores. Antibiotics for acute appendicitis are safe and effective and may avoid unnecessary appendectomy, reducing operation rate, surgical risks, and overall costs. After 2 years, follow-up recurrences of conservatively treated acute appendicitis are less than 15% and maybe safely and effectively treated with further antibiotics.

*Trauma Surgery Unit, Maggiore Hospital Regional Trauma Center, Bologna Local Health District, AUSL, Bologna, Italy

I Unit, General and Emergency and Trauma Surgery, Ospedali Riuniti, Bergamo, Italy

Department of Surgery, Hospital of Macerata, Macerata, Italy; and

§Emergency and Trauma Surgery Department, Maggiore Hospital of Parma, Parma, Italy.

Reprints: Salomone Di Saverio MD, PhD, Emergency and Trauma Surgery Department, Maggiore Hospital Regional Trauma Center, Bologna Local Health District, 40100 Bologna, Italy. E-mail: salo75@inwind.it.

ClinicalTrials.gov identifier: NCT01096927

This article has been accepted and selected for Oral Presentation in the 2011 and 2012 Scientific Papers Sessions of the American College of Surgeons Clinical Congress and has been presented by Dr Di Saverio at the session SP16, on October 27, 2011, in San Francisco and at the session SP10, on October 3, 2012, in Chicago.

Disclosure: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. The authors declare no conflicts of interest (financial or other).

© 2014 by Lippincott Williams & Wilkins.