The NOTA Study (Non Operative Treatment for Acute Appendicitis)

Saverio, Salomone Di; Sibilio, Andrea; Giorgini, Eleonora; Biscardi, Andrea; Villani, Silvia; Catena, Fausto; Smerieri, Nazareno; Pisano, Michele; Ansaloni, Luca; Sartelli, Massimo; Catena, Fausto; Tugnoli, Gregorio

doi:10.1097/sla.0000000000000560

Cited by 245 publications

(114 citation statements)

References 35 publications

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“…Long-term follow-up from non-randomized trials and observational studies, lasting up to 7 years, does not demonstrate higher rates of recurrence [37]. The recently published NOTA study demonstrated a success rate of 83% for NOM after a 2-year follow-up [38]. The mean time for recurrence was after approximately 4 months, therefore suggesting that longer follow up-periods do not necessarily lead to significantly higher rates of recurrent disease.…”

Section: Why Do Not Remove All Of Them?mentioning

confidence: 99%

Clinical Management of Appendicitis

2018

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Background: Ever since the first appendectomy has been performed, surgery has been the standard of care for acute appendicitis, with antibiotic therapy being reserved for special situations. Recent studies have shown the feasibility of antibiotic therapy for uncomplicated appendicitis. Methods: This clinical therapeutic review is based both on author expertise and a selective literature survey in PubMed based on the term ‘appendicitis', combined with the terms ‘acute', ‘complicated', ‘conservative', ‘non-operative', ‘therapy', ‘surgery', and ‘strategy'. According to these search results as well as to the treatment guidelines from the American College of Surgeons, Society for Surgery of the Alimentary Tract, Society of American Gastrointestinal and Endoscopic Surgeons, European Association of Endoscopic Surgery, and World Society of Emergency Surgery, we present an interdisciplinary treatment concept. Results: Approximately 90% of patients treated with antibiotics are able to avoid surgery during the initial admission. The other 10% that fail to respond to antibiotics require a rescue appendectomy. Recurrence rates of non-operated patients within 1 year are as high as 20-30%. Conclusion: In uncomplicated appendicitis without risk factors for failure of non-operative management, a shared decision based on the patient's preferences should be made. In cases with risk factors, appendectomy is still the treatment recommended. If the diagnosis is uncertain or clinical symptoms are rather mild, antibiotic therapy should be started. In complicated appendicitis, management depends on the clinical state, with either immediate surgery or primarily antibiotic therapy and combined with drainage of abscess, being followed by interval appendectomy in some cases.

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Section: Why Do Not Remove All Of Them?mentioning

confidence: 99%

Clinical Management of Appendicitis

2018

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“…A non-inferiority analysis will be performed to compare the primary and secondary outcomes. Based on current adult literature, the treatment efficacy difference between operative and non-operative treatment is about 25–35% 11–19. The most recent RCT in adults used 25% as its non-inferiority margin 19.…”

Section: Discussionmentioning

confidence: 99%

“…Prospective studies, systematic reviews and meta-analyses have demonstrated that antibiotics are a safe and effective treatment for AUA in adults 11–19. The Appendicitis Acuta (APPAC) multicentre, open-label, non-inferiority, randomised controlled trial (RCT) in adults reported a significantly lower overall complication rate of 2.8% in the NOM group, compared with 20.5% in patients who received operative management (OM).…”

Section: Introductionmentioning

confidence: 99%

Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

Liu

Adams

et al. 2016

BMJ Open

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IntroductionThis article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention.DesignA multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals.ParticipantsChildren who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients.InterventionsChildren in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost.AnalysisData analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05.Ethics and disseminationThe research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations.Trial registration numbersNCT02795793; ACTRN12616000788471.

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“…1,20 Most studies have been performed in patients with only uncomplicated appendicitis. However, Hansson et al 21 conducted a randomized clinical trial aimed at unselected patients.…”

Section: Discussionmentioning

confidence: 99%

“…1–3 The reported recurrence rates vary widely from 5% to 37%. 4 Some authors have also suggested that there is a risk of potentially missing a diagnosis for the patients treated nonoperatively because there is no surgical exploration and therefore no specimens retrieved for pathologic examination.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Recurrence Management in Patients Who Underwent Nonsurgical Treatment for Acute Appendicitis

et al. 2016

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The recurrence rate for acute appendicitis treated nonoperatively varies between studies. Few studies have adequately evaluated the management of these patients when appendicitis recurs. We aimed to explore the recurrence rate and management of patients with acute appendicitis that were first treated nonoperatively.We identified patients in the Taiwan National Health Insurance Research Database who were hospitalized due to acute appendicitis for the first time between 2000 and 2010 and received nonsurgical treatment. The recurrence and its management were recorded. Data were analyzed to access the risk factors for recurrence and factors that influenced the management of recurrent appendicitis.Among the 239,821 patients hospitalized with acute appendicitis for the first time, 12,235 (5.1%) patients were managed nonoperatively. Of these, 864 (7.1%) had a recurrence during a median follow-up of 6.5 years. Appendectomy was performed by an open and laparoscopic approach in 483 (55.9%) and 258 (29.9%) patients, respectively. The remaining 123 (14.2%) patients were again treated nonsurgically. Recurrence was independently associated with young age, male sex, percutaneous abscess drainage, and medical center admission by multivariable analysis. In addition, age <18, a (CCI) <2, medical center admission, and a longer time to recurrence were correlated with using laparoscopy to treat recurrence. Neither type of appendicitis, percutaneous abscess drainage, nor length of first time hospital stay had an influence on the selection of surgical approach.In conclusion, a laparoscopic appendectomy can be performed in recurrent appendicitis cases, and its application may not be related to previous appendicitis severity.

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The NOTA Study (Non Operative Treatment for Acute Appendicitis)

Cited by 245 publications

References 35 publications

Clinical Management of Appendicitis

Clinical Management of Appendicitis

Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

Analysis of Recurrence Management in Patients Who Underwent Nonsurgical Treatment for Acute Appendicitis

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