BiZact versus cold steel for post-tonsillectomy hemorrhage: a multicenter randomized trial.

ABSTRACT:

Purpose

To compare post-tonsillectomy hemorrhage (PTH) rates and severity between BiZact and cold steel tonsillectomy in a multicenter randomized controlled trial (RCT).

Methods

This non-inferiority RCT was conducted at five Danish hospitals between June 2022 and May 2024. Patients aged ≥ 4 years undergoing tonsillectomy for benign indications were randomized to BiZact or cold steel dissection. Patients and caregivers were blinded to group assignment. Primary outcome was PTH within 30 days, categorized by severity: spontaneous hemostasis, treatment in local anesthesia, or general anesthesia. Secondary outcomes included operative time, blood loss, infection, and readmission due to pain. Modified Poisson regression with robust standard errors was used to estimate relative risk

SUBMITTER: Molhave M 

PROVIDER: S-EPMC12680691 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature