Tonsillectomy Using BiZact Tonsilletomy Device

Not Applicable

• Conditions: Tonsillectomy
• Interventions: Device: Bizact tonsillectomy device

• Registration Number: NCT04320095
• Lead Sponsor: University of Calgary

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-22
• Study First Submitted QC: 2020-03-22
• Study First Posted: 2020-03-24
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31
• Study Start: 2020-06
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Children scheduled for tonsillectomy at Alberta Children Hospital
2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.

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Exclusion Criteria

1. Craniofacial abnormalities
2. Bleeding disorders
3. Complex medical background

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bizact device for one tonsil	Bizact tonsillectomy device	Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy.
Bizact device for both tonsils	Bizact tonsillectomy device	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)
Electrocautery for both tonsils	Bizact tonsillectomy device	As explained on the above arm description
Electrocautery for second tonsil	Bizact tonsillectomy device	Electrocautery is the standard technique used at our institution.

Primary Outcome Measures

Name	Time	Method
Operative time	during the procedure	The study will be considered success if the mean intra operative time using Bizact device is less than that using electrocautery

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood loss	during the procedure	The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery