A randomized clinical single-center trial comparing antibiotics to surgery for the treatment of computed tomography-uncomplicated acute appendicitis in adults: the Kouba non operative management of acute appendicitis trial protocol
Keywords:Acute appendicitis, Appendectomy, Antibiotic therapy, Non operative management
Background: Several Western studies support the idea that some acute appendicitis (AA) can be successfully treated by antibiotics. The rationale for the non-operative treatment is essentially based on the non-futility of the vermicular appendix which seems to play a major role in the pathophysiology of the digestive tract. However, this approach still suffers from a failure rate of around 20-30% in the first year, rising to nearly half of patients within 5 years. In Algeria, appendectomy is still the standard of care. Through rigorous selection, the Kouba non operative management of acute appendicitis (KNOMA) trial aims to determine whether non-operative treatment (NOT) is non-inferior to surgery.
Methods: KNOMA is a randomized, controlled, non-inferiority trial designed to enroll 180 adults with CT-confirmed uncomplicated AA. Participants are randomized to appendectomy or 9 days of antibiotics (Abx). The primary endpoint is the failure rate at 12 months. This trial was designed to take into account the specifics of the Algerian population and practices in Algeria.
Conclusions: This is the first trial in Africa and middle-income countries to evaluate the comparative efficacy of antibiotics and appendectomy for the treatment of CT-confirmed uncomplicated acute appendicitis based on failure rate assessment.
Trial registration: This trial was registered on pactr.org on 28 March 2022 (PACTR202203751640059).
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