Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2025
BiZact versus cold steel for post-tonsillectomy hemorrhage: a multicenter randomized trial.
Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05270109 (Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Cold Steel Versus "Hot" BiZact Tonsillectomy; Comparing Post Tonsillectomy Morbidity
Who cites it
1 citing paper in PubMed.
- The Impact of Surgical Technique on Post-Tonsillectomy Hemorrhage-A Registry-Based Cohort Study.Laryngoscope investigative otolaryngology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo compare post-tonsillectomy hemorrhage (PTH) rates and severity between BiZact and cold steel tonsillectomy in a multicenter randomized controlled trial (RCT).
methodsThis 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.
resultsOf 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.
conclusionBiZact 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 registrationRegistered at ClinicalTrials.gov, ID NCT05270109. Registered March 7, 2022.
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