Tonsillectomy
Conditions
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.
Interventions
DEVICEBizact tonsillectomy device
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.
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | during the procedure | The study will be considered success if the mean intraoperative blood loss using Bizact is less than Electrocautery |
Contacts
Primary ContactKhaloud Al Bahri, MD
Backup ContactWarren Yunker, MD, PhD
Outcome results
None listed