Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]

Background: Various topical applications provide varying pain control outcomes among patients undergoing surgery for anorectal conditions like haemorrhoids, anal fissures, and anal fistulae with varying outcomes. We evaluated the outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine as a local application following anorectal surgery. Methods: This was a prospective, single-arm, single-centre study with 50 patients who underwent anorectal surgery. Coprimary endpoints were 1) proportion of patients with minimal clinically important difference (MCID) defined as 10-point reduction in 100-mm visual analogue scale (VAS) score and 2) mean reduction in anal pain on VAS, from baseline to 3 and 6 weeks after surgery. Proportion of patients with complete wound healing and reduction in symptoms of itching, bleeding, and burning and incidence of adverse events (AEs) and tolerability were also assessed. Results: Of 50 patients, 18.0%, 26.0%, and 56.0% underwent haemorrhoidectomy, fissurectomy, and fistulectomy, respectively. All patients achieved MCID at week 3, which was maintained at 6 weeks. The mean VAS score for anal pain reduced significantly from 68.6 at baseline to weeks 3 and 6, respectively (p Conclusion: The topical FDC was effective, with a good safety and tolerability profile, in patients undergoing surgery for anorectal conditions. Clinical trial registration: CTRI/2020/11/029298.