PDF(Pubmed)
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.
METHODS: 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).
CONCLUSIONS: 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.
BACKGROUND: EudraCT Number: 2021-003376-14. Registered on November 26, 2021.
METHODS: 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).
CONCLUSIONS: 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.
BACKGROUND: EudraCT Number: 2021-003376-14. Registered on November 26, 2021.
摘要：
背景：肛门直肠瘘，这是一种相对常见的病理学，是形成肛门脓肿的急性直肠周围过程的慢性表现。肛门脓肿切开和引流后瘘的发展约为26-37％。它的治疗是一个相关的话题，使用抗生素治疗在预防中的作用仍然存在争议，在发表了几项具有矛盾结果和一些方法学局限性的研究之后。我们的假设是，阿莫西林和克拉维酸的组合将减少肛瘘的发生率。
方法：本研究的目的是评估肛周脓肿外科引流后抗生素治疗在肛周瘘发展中的疗效。PERIQxA研究是一个多中心，随机化，双盲对照试验。该研究旨在包括286名成年患者，他们将被随机（1：1）分配到实验（阿莫西林/克拉维酸875/125mgTDS，持续7天）或对照组（安慰剂）。主要结果指标是手术后和随访期间（6个月）发生肛瘘的患者百分比。
结论：本临床试验旨在评估阿莫西林/克拉维酸预防肛周瘘的有效性和安全性。这项研究的结果有望有助于稳定抗菌疗法在肛门脓肿治疗中的潜在作用。
背景：EudraCT编号：2021-003376-14。2021年11月26日注册。
方法：本研究的目的是评估肛周脓肿外科引流后抗生素治疗在肛周瘘发展中的疗效。PERIQxA研究是一个多中心，随机化，双盲对照试验。该研究旨在包括286名成年患者，他们将被随机（1：1）分配到实验（阿莫西林/克拉维酸875/125mgTDS，持续7天）或对照组（安慰剂）。主要结果指标是手术后和随访期间（6个月）发生肛瘘的患者百分比。
结论：本临床试验旨在评估阿莫西林/克拉维酸预防肛周瘘的有效性和安全性。这项研究的结果有望有助于稳定抗菌疗法在肛门脓肿治疗中的潜在作用。
背景：EudraCT编号：2021-003376-14。2021年11月26日注册。
