Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula (PERIQxA study): study protocol for a multicenter randomized, double-blind clinical trial.

BACKGROUND: Anorectal fistula, which is a relatively common pathology, is the chronic manifestation of the acute perirectal process that forms an anal abscess. The development of a fistula after incision and drainage of an anal abscess is seen in approximately 26-37%. Its treatment is a relevant topic, and the role of the use of antibiotic therapy in its prevention remains controversial, after the publication of several studies with contradictory results and several methodological limitations. Our hypothesis is that the combination of amoxicillin and clavulanic acid will reduce the incidence of anal fistula. METHOD: The aim of this study is to evaluate the efficacy of antibiotherapy after surgical drainage of perianal abscess in the development of perianal fistula. The PERIQxA study is a multicenter, randomized, double-blind controlled trial. The study has been designed to include 286 adult patients who will be randomly (1:1) assigned to either the experimental (amoxicillin/clavulanic acid 875/125 mg TDS for 7 days) or the control arm (placebo). The primary outcome measure is the percentage of patients that develop perianal fistula after surgery and during follow-up (6 months). DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of amoxicillin/clavulanic in the prevention of perianal fistula. The results of this study are expected to contribute to stablish the potential role of antibiotherapy in the therapeutics for anal abscess. TRIAL REGISTRATION: EudraCT Number: 2021-003376-14. Registered on November 26, 2021.

Update on the management of uncomplicated acute diverticulitis at our centre. Equally effective, more efficient. / Actualización del manejo de la diverticulitis aguda no complicada en nuestro centro. Igualmente efectivo, más eficiente.

GOALS: The current trend in the treatment of non-complicated diverticulitis is the outpatient management with antibiotic or even anti-inflammatory regimens in selected cases. We present a comparison of the results in our hospital with different protocols applied in 2016 and 2017. MATERIAL AND METHODS: All patients selected for this study were diagnosed with diverticulitis grade Ia of Hinchey's classification according to radiological findings on abdominal CT. We have analyzed two retrospective cohorts: 100 patients treated in 2016 according to the old protocol and 104 patients treated in 2017 with a new protocol. In 2016, the candidates for ambulatory treatment remained under observation for 24 hours before being discharged. The treatment consisted of 14 days of ciprofloxacin and metronidazole. In 2017, only patients with more acute symptoms were observed 24 hours and amoxicillin-clavulanic acid was prescribed for only 5 days. RESULTS: The persistence of the disease in 2016 was 6% and in 2017 was only 5.77% (p = 0.944). Recurrence during the first year was 13% in the first group, while in the second it was 5.7%, although this difference was not statistically significant. Likewise, a significant reduction in health costs was achieved. CONCLUSIONS: Outpatient treatment of acute uncomplicated diverticulitis with oral treatment seems to be a safe and effective therapeutic strategy in selected patients with low comorbidity.