Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial

Study Overview
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Brief Summary
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Tonsillectomies are frequently followed by severe postoperative pain, hence high analgetics consumption and prolonged hospitalization. Also, postoperative hemorrhages can be hazardous. Constant evaluation of surgical techniques is paramount to improve safety and cost-effectiveness. Frequently tonsillectomies are performed in cold steel technique. Aim of this study will be the evaluation of handling, surgical time, postoperative pain and postoperative hemorrhage rates using the BiZactTM-Device in comparison to traditional techniques on the contralateral side. In one patient, two different techniques will be used. The primary objective will be the surgical time. Regardless of surgeon handedness, surgeons will randomly be assigned to either start with the left or right tonsil, and randomly either to start with the BiZact™ Device or with cold steel methods. Additionally, time to stop bleeding, intraoperative blood loss, tonsil mobility, device handling, as well as wound healing will be assessed.

Detailed Description
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Although stricter indication criteria have been implanted (especially in Austria since 2008), tonsillectomies are still performed very frequently. Post-surgical bleeding can potentially be life-threatening, and occur within 3 weeks after tonsillectomy. A broad survey in Great Britain revealed a postoperative hemorrhage rate in 33.921 patients between 1.5 and 5.4 %, varying on hospital size. Small collectives also showed rates up to 21.7%. Worldwide, different techniques are used. Generally, cold steel and hot techniques can be distinguished, although often current-carrying (hot) and cold instruments are used alternately. Postoperative pain seems to be uninfluenced by technique, whereas postoperative hemorrhage rates seem to be higher in hot techniques. LigaSure® is a bipolar current-carrying device, which is able to seal vessels. Simultaneously tissue impedance is measured to control energy application. In this way only the required energy levels are applied. Therefore LigaSure® can also be referred as a softened hot technique. In 2005 Lachanas et al. compared the LigaSure®-technique with the cold steel technique in 200 patients and found significantly less postoperative pain in favor of the LigaSure®-technique. Postoperative hemorrhage rates were not higher with LigaSure®. Based on the LigaSure®-scissors, Medtronic introduced a device specifically developed and licensed for tonsillectomies (BiZactTM). Aim of this study will be the evaluation of handling, surgical time, postoperative pain and postoperative hemorrhage rates in comparison to traditional techniques on the contralateral side. In one patient, two different techniques will be used. This side-controlled evaluation of surgical techniques in tonsillectomies has been proven successfully in previous studies.

Official Title
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Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial

Conditions
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Tonsillitis Chronic, Tonsillectomy, Hemorrhage, Postoperative Pain, Postoperative Hemorrhage, Surgery--Complications, Handling, Otorhinolaryngologic Diseases

Intervention / Treatment
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* Device: BiZactTM Open Sealer/Divider


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 14 and older Written informed consent (in case of underage participant also parental informed consent) Assigned for Tonsillectomy on both sides due to chronic tonsillitis Exclusion Criteria: History of abscesses in tonsillar region Coagulation disorder (as assessed by a coagulation questionnaire and blood results) Suspicion of untreated malignancy of any kind Planned removal of only one tonsil

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Cross-over block design with block sizes of 12, such that after 12 patients every group was chosen three times. 48 patients in 4 groups (BiZactTM first / BiZactTM second, BiZactTM right / BiZactTM left side).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BiZact™ device<br>BiZact™ device will be used appropriately to its purpose to remove one tonsil by: Incision of the anterior palatal arch Locating of the cranial pole of the tonsil Dissection of the tonsil capsule Localized coagulation of bleeding vessels Detaching of the inferior pole from the pharynx tissue | Device: BiZactTM Open Sealer/Divider<br>* The BiZactTM Open Sealer/Divider creates a seal by application of radiofrequency (RF) electrosurgical energy to blood and lymphatic vessels or tissue bundles interposed between the jaws of the instrument. A cutting blade within the instrument is surgeon-activated to divide tissue. It is a single-use device and will not be reused in other patients.<br>|
| Active Comparator: Cold steel dissection (CD)<br>Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over). | Device: BiZactTM Open Sealer/Divider<br>* The BiZactTM Open Sealer/Divider creates a seal by application of radiofrequency (RF) electrosurgical energy to blood and lymphatic vessels or tissue bundles interposed between the jaws of the instrument. A cutting blade within the instrument is surgeon-activated to divide tissue. It is a single-use device and will not be reused in other patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical time | For the aim of the study surgical time is defined as time from superior mucosal incision to the moment when the removed tonsil is placed on instrument table (recorded by theatre staff - stopwatch). | 1 hour (intraoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to stop bleeding | Time to stop bleeding per side after tonsil removal (recorded by theatre staff - stopwatch) | 1 hour (intraoperative) | 
| intraoperative blood loss | intraoperative blood loss as measured by A) secretion/blood volume in suction device side separately B) number of used swabs C) swab weight (documented by surgical assistant, side separately at the earliest time point after removal out of the oral cavity - weighing scale provided only for this investigation) | 1 hour (intraoperative) | 
| Postoperative pain assessment | Postoperative pain assessment A) using a side specific questionnaire (visual analogue scales (VAS-Scale) 0-100mm: differences of more than 16mm can be judged as significant in style of Bijur et al. 2001) on days 0, 1, 3, 5, 7 and 10. B) follow-up phone call 2 months after surgery (or in-visit as preferred by the patient) assesses for swallowing difficulties and residual pain in side comparison. | Day of surgery until 2 months after surgery | 
| Wound healing | Wound healing on a VAS-Scales for each side (from 0 very nice tissue / no inflammation to 100mm scale very thick fibrin / strong inflammation as seen by redness/secretion) (evaluated by ENT specialist not familiar with previous randomized side in course of postoperative follow-up visit including review of histological findings) | approx. 10 days after surgery | 
| Tonsil mobility intraoperatively | Tonsil mobility intraoperatively on a VAS-Scales for each side (from 0 not mobile to 100mm very easy to move) | intraoperative |