Performance of perioperative antibiotics against postendoscopic submucosal dissection coagulation syndrome: a multicenter randomized controlled trial.

Abstract

BACKGROUND AND AIMS\nThis study aimed to evaluate the efficacy of perioperative antibiotics against postendoscopic submucosal dissection (ESD) coagulation syndrome (PECS) in patients undergoing colorectal ESD.\n\n\nMETHODS\nA prospective, multicenter, randomized controlled, parallel, superiority trial was conducted at 21 Japanese tertiary institutions. Patients with superficial colorectal lesions ≥20 mm and those undergoing ESD management for a single lesion were eligible. Patients with perforation during and after ESD were excluded. Before the ESD procedure, participants were randomly assigned (1:1) to either undergo conventional treatment (nonantibiotic group) or investigational treatment (antibiotic group). In the antibiotic group, 3 g of ampicillin-sulbactam was administered just before, 8 hours after, and the morning after ESD. The primary endpoint was the incidence of PECS. The onset of PECS was defined as localized abdominal pain (both spontaneous pain and tenderness), and fever (≧37.6°C) or inflammatory response (leukocytosis [≧10,000 cells/μL] or elevated C-reactive protein level (CRP) [≧0.5 mg/dL]).\n\n\nRESULTS\nFrom February 5, 2019 to September 7, 2020, a total of 432 patients were enrolled and assigned to the antibiotic group (n=216) or nonantibiotic group (n=216). After excluding 52 patients, 192 in the antibiotic group and 188 in the nonantibiotic group were analyzed. PECS occurred in 9 out of 192 (4.7%) patients in the antibiotic group and 14 out of 188 (7.5%) patients in the nonantibiotic group with an odds ratio of 0.61 (95% confidence interval, 0.23 -1.56, p=0.29).\n\n\nCONCLUSIONS\nPerioperative use of antibiotics was not effective in reducing incidence of PECS in patients undergoing colorectal ESD.