Postero-lateral Internal Sphincterotomy vs Botulinum Toxin Injection in the Treatment of Chronic Anal Fissure
Status:
Recruiting
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
We hypothesized that optimization of the dose of the Botulinum toxin injection (BT) and
standardization of the technique of lateral internal sphincterotomy to posterolateral
internal sphincterotomy (PIAS) could, in turn, report a conclusive result which helps to
provide better care to patients with chronic anal fissure. So, we will conduct this trial as
a prospective randomized, controlled, intervention, open-label trial with two parallel
groups, and a primary endpoint of fissure healing during 6 months after the initial
intervention, with the randomization, will be performed by an online software with a 1:1
allocation. Eligible patients will be randomized in equal proportions between BT injection
and PIAS.