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Artés Caselles M.AuthorGonzález Alcolea N.AuthorLucena De La Poza J.l.AuthorSánchez Movilla A.AuthorRuiz-Antorán B.Author
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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

Publicated to:Trials. 25 (1): - 2024-12-01 25(1), DOI: 10.1186/s13063-024-07922-3

Authors: Polaino Moreno V; Caballero-Bermejo AF; Artés Caselles M; Serrano González J; Remírez Arriaga X; González Alcolea N; Equisoain Azcona A; Iglesias García E; Lucena de la Poza JL; Sánchez Movilla A; Ruiz-Antorán B

Affiliations

Hospital Universitario de Torrejón - Author
Hospital Universitario Infanta Cristina - Author
Hospital Universitario La Paz - Author
Hospital Universitario Puerta de Hierro Majadahonda - Author

Abstract

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.

Keywords
AbscessAntibioticsColorectal surgeryFistula-in-anoPerianalQuality of life

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Trials due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2024 there are still no calculated indicators, but in 2023, it was in position , thus managing to position itself as a Q2 (Segundo Cuartil), in the category Medicine (Miscellaneous). Notably, the journal is positioned en el Cuartil Q3 for the agency WoS (JCR) in the category Medicine, Research & Experimental.

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-05-11:

  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 3 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

    It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

    • The work has been submitted to a journal whose editorial policy allows open Open Access publication.
    Leadership analysis of institutional authors

    There is a significant leadership presence as some of the institution’s authors appear as the first or last signer, detailed as follows: Last Author (RUIZ ANTORAN, BELEN).