Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial: a protocol for the pragmatic randomised study of appendicitis treatment

Abstract

IntroductionSeveral European studies suggest that some patients with appendicitis can be treated safely with antibiotics. A portion of patients eventually undergo appendectomy within a year, with 10%–15% failing to respond in the initial period and a similar additional proportion with suspected recurrent episodes requiring appendectomy. Nearly all patients with appendicitis in the USA are still treated with surgery. A rigorous comparative effectiveness trial in the USA that is sufficiently large and pragmatic to incorporate usual variations in care and measures the patient experience is needed to determine whether antibiotics are as good as appendectomy.ObjectivesThe Comparing Outcomes of Antibiotic Drugs and Appendectomy (CODA) trial for acute appendicitis aims to determine whether the antibiotic treatment strategy is non-inferior to appendectomy.Methods/AnalysisCODA is a randomised, pragmatic non-inferiority trial that aims to recruit 1552 English-speaking and Spanish-speaking adults with imaging-confirmed appendicitis. Participants are randomised to appendectomy or 10 days of antibiotics (including an option for complete outpatient therapy). A total of 500 patients who decline randomisation but consent to follow-up will be included in a parallel observational cohort. The primary analytic outcome is quality of life (measured by the EuroQol five dimension index) at 4 weeks. Clinical adverse events, rate of eventual appendectomy, decisional regret, return to work/school, work productivity and healthcare utilisation will be compared. Planned exploratory analyses will identify subpopulations that may have a differential risk of eventual appendectomy in the antibiotic treatment arm.Ethics and disseminationThis trial was approved by the University of Washington’s Human Subjects Division. Results from this trial will be presented in international conferences and published in peer-reviewed journals.Trial registration numberNCT02800785.

Acute Appendicitis Review: Background, Epidemiology, Diagnosis, and Treatment

“…It is suggested that uncomplicated appendicitis may resolve with antibiotic treatment alone [29]. Reports show that appendicitis treated with antibiotics has a 91% success rate in the short term with 71% becoming appendectomy-free by one year [30]. In the United States, conservative management with antibiotics prior to surgical intervention has demonstrated positive results [31].…”

Defining treatment strategy for uncomplicated appendicitis based on patient satisfaction feedback: A cross-sectional study

“…The quality of life associated with appendicitis treatment was considered in previous studies by comparing outcomes following antibiotic drug treatment and appendectomy [10,23,24]. Previous studies evaluated health-related quality of life (HR-QOL) and related factors [25] and compared ELA and ILA for appendicitis in terms of patient quality of life and its effects on parents and patients [26].…”

“…Previous studies evaluated health-related quality of life (HR-QOL) and related factors [25] and compared ELA and ILA for appendicitis in terms of patient quality of life and its effects on parents and patients [26]. According to previous research, using antibiotics alone had a smaller impact on social life, and patients resumed their normal activity earlier than after surgery [23]. However, long-term QOL of patients taking antibiotics who later underwent appendectomy were less satis ed than patients with successful antibiotics or appendectomy [24].…”

“…In this study, we were unable to compare the subjective symptoms of ELA with those of ILA, because ILA was not performed during active symptoms. HR-QOL has been measured in previous clinical trials using such tools as the 36-item Short Form Survey Instrument (SF-36) and the EuroQoL-5D (EQ-5D) [10,23,25]. We regarded assessment of the treatment satisfaction of patients to be insu cient because both ILA and ELA surgeries had equal surgical outcomes.…”

Appendiceal Adenocarcinoma Found by Surgery for Acute Appendicitis is Associated with Older Age – A Retrospective Cohort Study

“…A meta-analysis from Europe reported that the treatment of acute appendicitis was approached with antibiotic therapy in 40-45% of the patients compared to less than 5% in the United States (7,8). This shift in clinical practice has raised concern regarding the risk of missing an appendiceal neoplasms in patients who receive non-operative therapy (9). While the overall incidence remains low, there are neither established criteria to determine which patients are eligible for medical management nor criteria for patients who may require oncologic surveillance after non-operative treatment for appendicitis.…”