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.

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.

Reverse TAR may be added when necessary in open preperitoneal repair of lateral incisional hernias: a retrospective multicentric cohort study.

BACKGROUND: The best approach for lateral incisional hernia is not known. Posterior component separation (reverse TAR) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane. The aim of our multicenter study was to compare the operative and patient-reported outcomes measures (PROMs) using two open surgical techniques from the lateral approach: a totally preperitoneal vs a reverse TAR. METHODS: A retrospective cohort study was performed since 2012 to 2020. Patients with lateral incisional hernia treated through a lateral approach were identified from a prospectively maintained multicenter database. Reverse TAR was added when the preperitoneal plane could not be safely dissected. The results obtained using these two lateral approaches were compared, including short- and long-term complications, as well as PROMs, using the specific tool EuraHSQoL. RESULTS: A total of 61 patients were identified. Reverse TAR was performed in 33 patients and lateral retromuscular preperitoneal approach in 28 patients. Both groups were comparable in terms of sociodemographic and comorbidities variables. Surgical site occurrences occurred in 13 cases (21.3%), with 8 patients (13.1%) requiring procedural intervention. During a median follow-up of 34 months, no incisional hernia recurrence was registered. There was a case (1.6%) of symptomatic bulging that required reoperation. Also 12 patients (19.7%) presented an asymptomatic bulging. No statistically significant difference was identified in the complications and PROMs between the two procedures. CONCLUSION: The open lateral retromuscular reconstruction using very large meshes that reach the midline has excellent long-term results with acceptable postoperative complications, including PROMs. A reverse TAR may be added, when necessary, without increasing complications and obtaining similar long-term results.