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

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2024年2月15日

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Verónica Polaino Moreno,
Antonio F. Caballero-Bermejo,
Mariano Artés Caselles,
Javier Serrano González,
Xabier Remírez Arriaga,
Natalia González Alcolea,
Aritz Equisoain Azcona,
Eva Iglesias García,
José Luis Lucena de la Poza,
Arsenio Sánchez Movilla,
Belén Ruiz-Antorán,
Isabel Alonso Sebastián,
Daniel Melero Montes,
Carmen León Fernández,
Jesús Álvarez Sánchez,
Joaquín Muñoz Rodríguez,
Juan González González,
Miguel García-Oria Serrano,
Ana Sánchez Ramos,
Arturo García Pavía,
Elena Jiménez Cubedo,
Laura Román García de León,
Maria Dolores Chaparro Cabezas,
Javier López Monclús,
Alberto Pueyo Rabanal,
Matías Cea Soriano,
Pedro Artuñedo Pe,
Xiana Rial Justo,
Miguel Suárez Sánchez,
Lucía Gil Cidoncha,
María del Pilar Martín Rodrigo,
María Torguet Muñoz,
Manuel Fernández Rodriguez,
Cristián Grillo Marín,
Celia Fidalgo Martínez,
Javier Callau Pontaque,
Pablo Galindo Jara,
Laura Colao García,
David Díaz Pérez,
Ana Belén Gallardo Herrera,
Enrique Esteban Agustí,
Miguel A. Hernández Bartolomé,
María Gutierrez Samaniego,
César García Llorente,
Lorenzo Rabadán Ruiz,
Raquel Barriga Sánchez,
Hector Ernesto Núñez Tasaico,
Jaime Zabala Salinas,
Natalia Almeida Romera,
Raquel Ríos Blanco,
Benito Miguel Josa Martínez,
Eneida Bra Insa,
Elena Sagarra Cebolla,
Mónica García Aparicio,
Paloma Garaulet González,
Eduardo San Pío Carvajal,
Miriam Fraile Vasallo,
José Manuel Muros Bayo,
Sergio Pedro Olivares Pizarro,
Vicente Herrera Cabrera,
Isaac Silvio Corrales Castillo,
Elsa Pertejo Muñoz,
Ricardo Ortega García,
Ana Sánchez Gollarte,
Rocío Maqueda González,
Carlos Sáez Rodríguez,
Mario Álvarez Gallego,
Beatriz Díaz San Andrés,
Ramón Cantero Cid,
Carolina González Gómez,
Inés Rubio Pérez,
Fernando Tone Villanueva,
Luis Asensio Gómez,
Esteban Díaz Serrano,
Blanca Monje Vera,
Celia Castillo Marcos,
Ana Belén Suárez Enriquez,
Rebeca Abad Moret,
Kriss Huerta Serracin

摘要

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.