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
© 2024. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Trials - 25(2024), 1 vom: 15. Feb., Seite 122 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
74469-00-4 |
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| Anmerkungen: |
Date Completed 16.02.2024 Date Revised 17.02.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s13063-024-07922-3 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368456684 |
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| 100 | 1 | |a Polaino Moreno, Verónica |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula (PERIQxA study) |b study protocol for a multicenter randomized, double-blind clinical trial |
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| 500 | |a Date Completed 16.02.2024 | ||
| 500 | |a Date Revised 17.02.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: EudraCT Number: 2021-003376-14. Registered on November 26, 2021 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Abscess | |
| 650 | 4 | |a Antibiotics | |
| 650 | 4 | |a Colorectal surgery | |
| 650 | 4 | |a Fistula-in-ano | |
| 650 | 4 | |a Perianal | |
| 650 | 4 | |a Quality of life | |
| 650 | 7 | |a Amoxicillin-Potassium Clavulanate Combination |2 NLM | |
| 650 | 7 | |a 74469-00-4 |2 NLM | |
| 700 | 1 | |a Caballero-Bermejo, Antonio F |e verfasserin |4 aut | |
| 700 | 1 | |a Artés Caselles, Mariano |e verfasserin |4 aut | |
| 700 | 1 | |a Serrano González, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a Remírez Arriaga, Xabier |e verfasserin |4 aut | |
| 700 | 1 | |a González Alcolea, Natalia |e verfasserin |4 aut | |
| 700 | 1 | |a Equisoain Azcona, Aritz |e verfasserin |4 aut | |
| 700 | 1 | |a Iglesias García, Eva |e verfasserin |4 aut | |
| 700 | 1 | |a Lucena de la Poza, José Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Sánchez Movilla, Arsenio |e verfasserin |4 aut | |
| 700 | 1 | |a Ruiz-Antorán, Belén |e verfasserin |4 aut | |
| 700 | 0 | |a PERIQxA Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Alonso Sebastián, Isabel |e investigator |4 oth | |
| 700 | 1 | |a Melero Montes, Daniel |e investigator |4 oth | |
| 700 | 1 | |a León Fernández, Carmen |e investigator |4 oth | |
| 700 | 1 | |a Álvarez Sánchez, Jesús |e investigator |4 oth | |
| 700 | 1 | |a Muñoz Rodríguez, Joaquín |e investigator |4 oth | |
| 700 | 1 | |a González González, Juan |e investigator |4 oth | |
| 700 | 1 | |a García-Oria Serrano, Miguel |e investigator |4 oth | |
| 700 | 1 | |a Sánchez Ramos, Ana |e investigator |4 oth | |
| 700 | 1 | |a García Pavía, Arturo |e investigator |4 oth | |
| 700 | 1 | |a Jiménez Cubedo, Elena |e investigator |4 oth | |
| 700 | 1 | |a Román García de León, Laura |e investigator |4 oth | |
| 700 | 1 | |a Chaparro Cabezas, Maria Dolores |e investigator |4 oth | |
| 700 | 1 | |a López Monclús, Javier |e investigator |4 oth | |
| 700 | 1 | |a Pueyo Rabanal, Alberto |e investigator |4 oth | |
| 700 | 1 | |a Cea Soriano, Matías |e investigator |4 oth | |
| 700 | 1 | |a Artuñedo Pe, Pedro |e investigator |4 oth | |
| 700 | 1 | |a Rial Justo, Xiana |e investigator |4 oth | |
| 700 | 1 | |a Suárez Sánchez, Miguel |e investigator |4 oth | |
| 700 | 1 | |a Gil Cidoncha, Lucía |e investigator |4 oth | |
| 700 | 1 | |a Martín Rodrigo, María Del Pilar |e investigator |4 oth | |
| 700 | 1 | |a Torguet Muñoz, María |e investigator |4 oth | |
| 700 | 1 | |a Fernández Rodriguez, Manuel |e investigator |4 oth | |
| 700 | 1 | |a Grillo Marín, Cristián |e investigator |4 oth | |
| 700 | 1 | |a Fidalgo Martínez, Celia |e investigator |4 oth | |
| 700 | 1 | |a Callau Pontaque, Javier |e investigator |4 oth | |
| 700 | 1 | |a Galindo Jara, Pablo |e investigator |4 oth | |
| 700 | 1 | |a Colao García, Laura |e investigator |4 oth | |
| 700 | 1 | |a Díaz Pérez, David |e investigator |4 oth | |
| 700 | 1 | |a Gallardo Herrera, Ana Belén |e investigator |4 oth | |
| 700 | 1 | |a Esteban Agustí, Enrique |e investigator |4 oth | |
| 700 | 1 | |a Hernández Bartolomé, Miguel A |e investigator |4 oth | |
| 700 | 1 | |a Gutierrez Samaniego, María |e investigator |4 oth | |
| 700 | 1 | |a García Llorente, César |e investigator |4 oth | |
| 700 | 1 | |a Rabadán Ruiz, Lorenzo |e investigator |4 oth | |
| 700 | 1 | |a Barriga Sánchez, Raquel |e investigator |4 oth | |
| 700 | 1 | |a Núñez Tasaico, Hector Ernesto |e investigator |4 oth | |
| 700 | 1 | |a Zabala Salinas, Jaime |e investigator |4 oth | |
| 700 | 1 | |a Almeida Romera, Natalia |e investigator |4 oth | |
| 700 | 1 | |a Ríos Blanco, Raquel |e investigator |4 oth | |
| 700 | 1 | |a Josa Martínez, Benito Miguel |e investigator |4 oth | |
| 700 | 1 | |a Bra Insa, Eneida |e investigator |4 oth | |
| 700 | 1 | |a Sagarra Cebolla, Elena |e investigator |4 oth | |
| 700 | 1 | |a García Aparicio, Mónica |e investigator |4 oth | |
| 700 | 1 | |a Garaulet González, Paloma |e investigator |4 oth | |
| 700 | 1 | |a San Pío Carvajal, Eduardo |e investigator |4 oth | |
| 700 | 1 | |a Fraile Vasallo, Miriam |e investigator |4 oth | |
| 700 | 1 | |a Muros Bayo, José Manuel |e investigator |4 oth | |
| 700 | 1 | |a Olivares Pizarro, Sergio Pedro |e investigator |4 oth | |
| 700 | 1 | |a Herrera Cabrera, Vicente |e investigator |4 oth | |
| 700 | 1 | |a Corrales Castillo, Isaac Silvio |e investigator |4 oth | |
| 700 | 1 | |a Pertejo Muñoz, Elsa |e investigator |4 oth | |
| 700 | 1 | |a Ortega García, Ricardo |e investigator |4 oth | |
| 700 | 1 | |a Sánchez Gollarte, Ana |e investigator |4 oth | |
| 700 | 1 | |a Maqueda González, Rocío |e investigator |4 oth | |
| 700 | 1 | |a Sáez Rodríguez, Carlos |e investigator |4 oth | |
| 700 | 1 | |a Álvarez Gallego, Mario |e investigator |4 oth | |
| 700 | 1 | |a Díaz San Andrés, Beatriz |e investigator |4 oth | |
| 700 | 1 | |a Cantero Cid, Ramón |e investigator |4 oth | |
| 700 | 1 | |a González Gómez, Carolina |e investigator |4 oth | |
| 700 | 1 | |a Rubio Pérez, Inés |e investigator |4 oth | |
| 700 | 1 | |a Tone Villanueva, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Asensio Gómez, Luis |e investigator |4 oth | |
| 700 | 1 | |a Díaz Serrano, Esteban |e investigator |4 oth | |
| 700 | 1 | |a Monje Vera, Blanca |e investigator |4 oth | |
| 700 | 1 | |a Castillo Marcos, Celia |e investigator |4 oth | |
| 700 | 1 | |a Suárez Enriquez, Ana Belén |e investigator |4 oth | |
| 700 | 1 | |a Abad Moret, Rebeca |e investigator |4 oth | |
| 700 | 1 | |a Huerta Serracin, Kriss |e investigator |4 oth | |
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