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

Area of Science:

• Otolaryngology
• Surgical Innovation
• Clinical Trials

Background:

• Post-tonsillectomy hemorrhage (PTH) is a significant complication.
• Comparing surgical techniques for tonsillectomy is crucial for patient safety.
• BiZact electrothermal bipolar forceps offer a potential alternative to traditional cold steel dissection.

Purpose of the Study:

• To compare the rates and severity of post-tonsillectomy hemorrhage (PTH) between BiZact and cold steel tonsillectomy.
• To evaluate the non-inferiority of BiZact tonsillectomy in preventing PTH.
• To assess secondary outcomes including operative time, blood loss, infection, and pain-related readmissions.

Main Methods:

• A multicenter, non-inferiority randomized controlled trial (RCT) involving patients aged ≥4 years undergoing tonsillectomy.
• Patients were randomized to either BiZact or cold steel dissection, with blinding for patients and caregivers.
• Primary outcome was PTH within 30 days, stratified by severity; secondary outcomes included operative parameters and complications. Modified Poisson regression was used for analysis.

Main Results:

• A total of 1,250 patients were randomized (645 BiZact, 605 cold steel).
• Return to theatre for bleeding occurred in 5% of BiZact patients versus 10% of cold steel patients (p=0.004).
• Overall PTH rates were 12% for BiZact and 17% for cold steel (p=0.02), with an adjusted relative risk of 0.70 for any PTH with BiZact.

Conclusions:

• BiZact tonsillectomy is associated with a significantly lower risk of severe and overall post-tonsillectomy hemorrhage compared to cold steel dissection.
• The study suggests BiZact is a safer alternative for tonsillectomy, potentially reducing bleeding complications.
• Higher absolute PTH rates observed may be attributed to comprehensive bleeding documentation in this trial.