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Open Access 01-12-2024 | Antibiotic | Study protocol

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

Authors: 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, PERIQxA Study Group

Published in: Trials | Issue 1/2024

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.

Available only for authorised users

Abcarian H. Anorectal infection: abscess-fistula. Clin Colon Rectal Surg. 2011;24(1):14–21. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22379401.CrossRefPubMedPubMedCentral

Ferrer-Márquez M, Espínola-Cortés N, Reina-Duarte Á, Granero-Molina J, Fernández-Sola C, Hernández-Padilla JM. Analysis and description of disease-specific quality of life in patients with anal fistula. Cirugía Española (English Ed. 2018;96(4):213–20. Available from: https://linkinghub.elsevier.com/retrieve/pii/S2173507718300735.

Parés D. Pathogenesis and treatment of fistula in ano. Br J Surg. 2010;98(1):2–3. Available from: https://academic.oup.com/bjs/article/98/1/2/6142250.CrossRefPubMed

Parks AG, Gordon PH, Hardcastle JD. A classification of fistula-in-ano. Br J Surg. 2005;63(1):1–12. Available from: https://academic.oup.com/bjs/article/63/1/1/6186513.CrossRef

Ghahramani L, Minaie MR, Arasteh P, Hosseini SV, Izadpanah A, Bananzadeh AM, et al. Antibiotic therapy for prevention of fistula in-ano after incision and drainage of simple perianal abscess: a randomized single blind clinical trial. Surgery. 2017;162(5):1017–25. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0039606017304427.CrossRefPubMed

Sözener U, Gedik E, Kessaf Aslar A, Ergun H, Halil Elhan A, Memikoğlu O, et al. Does adjuvant antibiotic treatment after drainage of anorectal abscess prevent development of anal fistulas? A randomized, placebo-controlled, double-blind, multicenter study. Dis Colon Rectum. 2011;54(8):923–9. Available from: https://journals.lww.com/00003453-201108000-00004.CrossRefPubMed

Lohsiriwat V, Yodying H, Lohsiriwat D. Incidence and factors influencing the development of fistula-in-ano after incision and drainage of perianal abscesses. J Med Assoc Thai. 2010;93(1):61–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20196412.PubMed

Włodarczyk M, Włodarczyk J, Sobolewska-Włodarczyk A, Trzciński R, Dziki Ł, Fichna J. Current concepts in the pathogenesis of cryptoglandular perianal fistula. J Int Med Res. 2021;49(2):300060520986669. Available from: http://www.ncbi.nlm.nih.gov/pubmed/33595349.CrossRefPubMed

Vogel JD, Johnson EK, Morris AM, Paquette IM, Saclarides TJ, Feingold DL, et al. Clinical practice guideline for the management of anorectal abscess, fistula-in-ano, and rectovaginal fistula. Dis Colon Rectum. 2016;59(12):1117–33. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27824697.CrossRefPubMed

10.

Owen HA, Buchanan GN, Schizas A, Cohen R, Williams AB. Quality of life with anal fistula. Ann R Coll Surg Engl. 2016;98(5):334–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27087327.CrossRefPubMedPubMedCentral

11.

Brar MS, Remzi F, Warusavitarne J, Datta I. Does antibiotic therapy prevent fistula in-ano after incision and drainage of simple perianal abscess? Can J Surg. 2020;63(4):E362-4. Available from: http://www.canjsurg.ca/lookup/doi/10.1503/cjs.017119.CrossRefPubMedPubMedCentral

12.

Tarasconi A, Perrone G, Davies J, Coimbra R, Moore E, Azzaroli F, et al. Anorectal emergencies: WSES-AAST guidelines. World J Emerg Surg. 2021;16(1):48. Available from: http://www.ncbi.nlm.nih.gov/pubmed/34530908.CrossRefPubMedPubMedCentral

13.

Mohamad Hasan R. Postoperative empirical antibiotic use for uncomplicated perianal abscess and fistula. Ann Color Res. 2016;5(1). Available from: http://colorectalresearch.neoscriber.org/en/articles/13476.html.

14.

Seow-En I, Ngu J. Routine operative swab cultures and post-operative antibiotic use for uncomplicated perianal abscesses are unnecessary. ANZ J Surg. 2017;87(5):356–9. Available from: https://onlinelibrary.wiley.com/doi/10.1111/ans.12936.CrossRefPubMed

15.

Nunoo-Mensah JW, Balasubramaniam S, Wasserberg N, Artinyan A, Gonzalez-Ruiz C, Kaiser AM, et al. Fistula-in-ano: do antibiotics make a difference? Int J Colorectal Dis. 2006;21(5):441–3. Available from: http://link.springer.com/10.1007/s00384-005-0022-4.CrossRefPubMed

16.

Mocanu V, Dang JT, Ladak F, Tian C, Wang H, Birch DW, et al. Antibiotic use in prevention of anal fistulas following incision and drainage of anorectal abscesses: a systematic review and meta-analysis. Am J Surg. 2019;217(5):910–7. Available from: http://www.ncbi.nlm.nih.gov/pubmed/30773213.CrossRefPubMed

Title: 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
Authors: 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
PERIQxA Study Group
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Antibiotic
Amoxicillin
Amoxicillin and Clavulanic Acid
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-07922-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Method

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Method

Discussion

Trial registration

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