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

Medical University of Vienna

Status: Completed

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

Treatments: Device: BiZactTM Open Sealer/Divider

Study type: Interventional

Funder types: Other

Identifiers

NCT03793816

EK Nr: 1399/2018

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 patients

Sex: All

Ages: 14 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

BiZact™ device

Active Comparator group

Description:

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

Treatment:

Device: BiZactTM Open Sealer/Divider

Cold steel dissection (CD)

Active Comparator group

Description:

Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).

Treatment:

Device: BiZactTM Open Sealer/Divider