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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

Randomized Controlled Trial

. 2014 Jul;260(1):109-17. doi: 10.1097/SLA.0000000000000560. 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 Andrea Sibilio, Eleonora Giorgini, Andrea Biscardi, Silvia Villani, Federico Coccolini, Nazareno Smerieri, Michele Pisano, Luca Ansaloni, Massimo Sartelli, Fausto Catena, Gregorio Tugnoli

Affiliations

Affiliation

¹ *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.

PMID: 24646528
DOI: 10.1097/SLA.0000000000000560

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Randomized Controlled Trial

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

Salomone Di Saverio et al. Ann Surg. 2014 Jul.

. 2014 Jul;260(1):109-17. doi: 10.1097/SLA.0000000000000560. Authors Salomone Di Saverio¹, Andrea Sibilio, Eleonora Giorgini, Andrea Biscardi, Silvia Villani, Federico Coccolini, Nazareno Smerieri, Michele Pisano, Luca Ansaloni, Massimo Sartelli, Fausto Catena, Gregorio Tugnoli Affiliation

¹ *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.

PMID: 24646528
DOI: 10.1097/SLA.0000000000000560

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Abstract

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 &OV0556;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.

Trial registration: ClinicalTrials.gov NCT01096927.

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Comment in

The NOTA (Non Operative Treatment for Acute Appendicitis) Study: One Step Beyond or Nearby?
Lubrano J, Menahem B. Lubrano J, et al. Ann Surg. 2016 Feb;263(2):e22. doi: 10.1097/SLA.0000000000000921. Ann Surg. 2016. PMID: 25211272 No abstract available.
The Challenge of Clinical Diagnosis of Appendicitis and Nonoperative Management of Patients With Right Lower Abdominal Pain.
Di Saverio S, Tugnoli G. Di Saverio S, et al. Ann Surg. 2016 Feb;263(2):e22-3. doi: 10.1097/SLA.0000000000001025. Ann Surg. 2016. PMID: 25371133 No abstract available.
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Reply to Letter: "Nonoperative Management of Right Iliac Fossa Pain: What Does Really Matter?".
Di Saverio S, Coccolini F, Sartelli M, Ansaloni L, Tugnoli G. Di Saverio S, et al. Ann Surg. 2016 Mar;263(3):e55. doi: 10.1097/SLA.0000000000001335. Ann Surg. 2016. PMID: 26079905 No abstract available.
The Non Operative Treatment for Acute Appendicitis (NOTA) Study: Is Less Surgery Better Surgery?
Foell D, Bahde R, Senninger N. Foell D, et al. Ann Surg. 2017 Jun;265(6):E83-E84. doi: 10.1097/SLA.0000000000001323. Ann Surg. 2017. PMID: 28486302 No abstract available.
How Reliable Is Alvarado Score and Its Subgroups in Ruling Out Acute Appendicitis and Suggesting the Opportunity of Nonoperative Management or Surgery?
Di Saverio S, Birindelli A, Piccinini A, Catena F, Biscardi A, Tugnoli G. Di Saverio S, et al. Ann Surg. 2017 Jun;265(6):E84-E85. doi: 10.1097/SLA.0000000000001548. Ann Surg. 2017. PMID: 28486303 No abstract available.