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

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 (RR) in an intention-to-treat analysis. Results Of 2,750 screened patients, 1,250 were randomized: 645 to BiZact and 605 to cold steel. Among 1,187 patients analyzed, return to theatre occurred in 5% of BiZact patients and 10% of cold steel patients ( p = 0.004). Bleeding managed in local anesthesia occurred in 7% in both groups; spontaneous hemostasis occurred in 3% versus 5%, respectively. Overall PTH rates were 12% for BiZact and 17% for cold steel ( p = 0.02). Adjusted RR for any PTH was 0.70 (95% CI: 0.53–0.92). No complications beyond predefined outcomes occurred. Conclusion BiZact tonsillectomy was associated with a lower risk of severe and overall PTH compared to cold steel. Comprehensive bleeding documentation may account for the higher absolute PTH rates compared to previous studies. Trial registration Registered at ClinicalTrials.gov, ID NCT05270109. Registered March 7, 2022.