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

January 2, 2021 updated by: Assoc. Prof. PD Dr. Gregor Heiduschka, Medical University of Vienna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BiZact™ device

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
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.
Active Comparator: Cold steel dissection (CD)
Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).
Device: BiZactTM Open Sealer/Divider
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical time
Time Frame: 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).
1 hour (intraoperative)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

October 23, 2020

Study Completion (Actual)

December 21, 2020

Study Registration Dates

First Submitted

January 1, 2019

First Submitted That Met QC Criteria

January 2, 2019

First Posted (Actual)

January 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 2, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK Nr: 1399/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

individual participant data (IPD) is not to be shared with third party members

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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