BiZact Tonsillectomy in the Pediatric Population

Postoperative Pain Clinical Trial

Official title: BiZact Tonsillectomy

Status Recruiting

Clinical Trial Summary

This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

Clinical Trial Description

Tonsillectomy is the second most common pediatric surgical procedure, with more than 280,000 performed in children under the age of 15 in the United States in 2010. The most common indications for tonsillectomy in children include recurrent infections and obstructive sleep apnea. While tonsillectomy in the pediatric population is generally safe and well-tolerated, post-operative complications are not uncommon, with post-operative pain, respiratory compromise, and post-tonsillectomy hemorrhage being chief among them.

Post-operative pain has been described as the main morbidity associated with tonsillectomy and is often ineffectively controlled. Pain beyond the initial 24-hour post-operative period has been noted to be worse with the use of electrocautery when compared to cold-knife dissection and snare tonsillectomy, perhaps attributable to the high levels of heat (400 °C to 600 °C) applied directly to the tonsillar area. Yet electrocautery remains one of the most frequently utilized tools due to its hemostatic effects through vessel coagulation at the time of dissection. Still, a recent large meta-analysis reported the rates of primary post-tonsillectomy hemorrhage (bleeding within the first 24 hours) at 2.4% and secondary post-tonsillectomy hemorrhage (beyond 24 hours) at 2.6%, suggesting that bleeding after tonsillectomy remains a relatively common occurrence. The search for a methodology that improves post-operative pain without increasing the risk of post-operative hemorrhage remains an active area of research.

Coblation, which creates an ionized plasma layer by passing a bipolar radio-frequency current through a medium of saline, offers another approach. The saline irrigation results in much less heat when compared to monopolar cautery, measuring approximately 40°C to 70°C. Coblation can be used in both subcapsular and intracapsular fashion. Subcapsular tonsillectomy with coblation has demonstrated a minimal decrease in pain, and may result in slightly higher rates of post-operative hemorrhage.

It has been pointed out that bipolar cautery could result in lower thermal injury and reduced blood loss, however tonsillectomy using traditional bipolar forceps leads to longer operative times. One group found that the use of BiClamp, a bipolar vascular sealing device originally designed for thyroidectomy, provided decreased operative times and less intraoperative bleeding compared to electrocautery. They noted, however, instances of posterior pillar perforation, which they attributed to curvature of the device that was designed for thyroid surgery, making dissection of the superior pole more difficult. Medtronic has now developed a similar device designed for use in tonsillectomy with a curved jaw meant to follow the contour of the tonsillar bed. In its marketing material for the recently developed BiZact , Medtronic describes a bipolar device that continuously measures the impedance of clamped tissue, adjusting energy levels in real-time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain.

In a pilot study of 186 patients, intraoperative blood loss was shown to be <1ml of blood loss in 71 cases (38.2%) and between 1 and 10ml of blood loss in 81 cases (43.5%). Post-operative hemorrhage rate of 4.3% is similar to rates described by other studies. BiZact tonsillectomy allows for a shortened operative time with a median time of 5.1 minutes. Other studies have shown other techniques to have a time duration of 21.6 minutes (electrocautery), 20.20 minutes (coblator), and 16.14 minutes (microdebrider).

In off label use of the device at our institution, data from surgeons using the device showed that surgeons perceived a relative improvement in following compared to standard tonsillectomy:

1. Less perceived thermal heat transfer to surrounding soft tissues

2. Left perceived blood loss

3. Superior ease of obtaining timely hemostasis

4. Faster operative time ;

Related Conditions & MeSH terms

• Hemorrhage
• Otorhinolaryngologic Diseases
• Postoperative Hemorrhage
• Postoperative Pain
• Surgery--Complications
• Tonsillectomy
• Tonsillitis
• Tonsillitis Chronic

• NCT number: NCT04725305
• Study type: Interventional
• Source: Baylor College of Medicine
• Contact: Ronald Vilela, M.D
• Phone: 832-822-3268
• Email: rjvilela@texaschildrens.org
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2021
• Completion date: June 30, 2024