Tonsillectomy Using BiZact Tonsilletomy Device

University of Calgary

Status: Unknown

Conditions: Tonsillectomy

Treatments: Device: Bizact tonsillectomy device

Study type: Interventional

Funder types: Other

Identifiers

NCT04320095

REB19-0088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Bizact device for one tonsil

Experimental group

Description:

Bizact tonsillecotmy device which is an advanced bipolar device using radiofrequency and pressure to ligate the encountered vessels during tonsillectomy.

Treatment:

Device: Bizact tonsillectomy device

Electrocautery for second tonsil

Active Comparator group

Description:

Electrocautery is the standard technique used at our institution.

Treatment:

Device: Bizact tonsillectomy device

Bizact device for both tonsils

Experimental group

Description:

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)

Treatment:

Device: Bizact tonsillectomy device

Electrocautery for both tonsils

Active Comparator group

Description:

As explained on the above arm description

Treatment:

Device: Bizact tonsillectomy device