Tonsillectomy Using BiZact Tonsilletomy Device

Study Overview
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Brief Summary
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The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.

Detailed Description
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It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants. Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils. With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.

Official Title
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BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial

Conditions
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Tonsillectomy

Intervention / Treatment
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* Device: Bizact tonsillectomy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children scheduled for tonsillectomy at Alberta Children Hospital Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing. Exclusion Criteria: Craniofacial abnormalities Bleeding disorders Complex medical background

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bizact device for one tonsil<br>Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy. | Device: Bizact tonsillectomy device<br>* Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.<br>|
| Active Comparator: Electrocautery for second tonsil<br>Electrocautery is the standard technique used at our institution. | Device: Bizact tonsillectomy device<br>* Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.<br>|
| Experimental: Bizact device for both tonsils<br>Consecutive cases of tonsillectomy will be done using Bizact device and compare the operative time collectively for those cases and compare it to same number of cases done using the standard procedure ( Electrocautery) | Device: Bizact tonsillectomy device<br>* Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.<br>|
| Active Comparator: Electrocautery for both tonsils<br>As explained on the above arm description | Device: Bizact tonsillectomy device<br>* Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery | during the procedure |