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

Not Applicable

Completed

• Conditions: Hemorrhage; Postoperative Pain; Otorhinolaryngologic Diseases; Handling; Tonsillitis Chronic; Tonsillectomy; Postoperative Hemorrhage; Surgery--Complications
• Interventions: Device: BiZactTM Open Sealer/Divider

• Registration Number: NCT03793816
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Study Start: 2019-09-01
• Primary Completion: 2020-10-23
• Study Completion: 2020-12-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-02
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

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

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold steel dissection (CD)	BiZactTM Open Sealer/Divider	Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).
BiZact™ device	BiZactTM Open Sealer/Divider	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

Primary Outcome Measures

Name	Time	Method
surgical time	1 hour (intraoperative)	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).

Secondary Outcome Measures

Name	Time	Method
Time to stop bleeding	1 hour (intraoperative)	Time to stop bleeding per side after tonsil removal (recorded by theatre staff - stopwatch)
Postoperative pain assessment	Day of surgery until 2 months after surgery	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.
Tonsil mobility intraoperatively	intraoperative	Tonsil mobility intraoperatively on a VAS-Scales for each side (from 0 not mobile to 100mm very easy to move)
intraoperative blood loss	1 hour (intraoperative)	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)
Wound healing	approx. 10 days after surgery	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)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria