<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03793816</url>
  </required_header>
  <id_info>
    <org_study_id>EK Nr: 1399/2018</org_study_id>
    <nct_id>NCT03793816</nct_id>
  </id_info>
  <brief_title>Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial</brief_title>
  <official_title>Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tonsillectomies are frequently followed by severe postoperative pain, hence high analgetics&#xD;
      consumption and prolonged hospitalization. Also, postoperative hemorrhages can be hazardous.&#xD;
      Constant evaluation of surgical techniques is paramount to improve safety and&#xD;
      cost-effectiveness. Frequently tonsillectomies are performed in cold steel technique. Aim of&#xD;
      this study will be the evaluation of handling, surgical time, postoperative pain and&#xD;
      postoperative hemorrhage rates using the BiZactTM-Device in comparison to traditional&#xD;
      techniques on the contralateral side. In one patient, two different techniques will be used.&#xD;
&#xD;
      The primary objective will be the surgical time. Regardless of surgeon handedness, surgeons&#xD;
      will randomly be assigned to either start with the left or right tonsil, and randomly either&#xD;
      to start with the BiZact™ Device or with &quot;cold steel&quot; methods.&#xD;
&#xD;
      Additionally, time to stop bleeding, intraoperative blood loss, tonsil mobility, device&#xD;
      handling, as well as wound healing will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although stricter indication criteria have been implanted (especially in Austria since 2008),&#xD;
      tonsillectomies are still performed very frequently. Post-surgical bleeding can potentially&#xD;
      be life-threatening, and occur within 3 weeks after tonsillectomy. A broad survey in Great&#xD;
      Britain revealed a postoperative hemorrhage rate in 33.921 patients between 1.5 and 5.4 %,&#xD;
      varying on hospital size. Small collectives also showed rates up to 21.7%.&#xD;
&#xD;
      Worldwide, different techniques are used. Generally, &quot;cold&quot; steel and &quot;hot&quot; techniques can be&#xD;
      distinguished, although often current-carrying (&quot;hot&quot;) and &quot;cold&quot; instruments are used&#xD;
      alternately. Postoperative pain seems to be uninfluenced by technique, whereas postoperative&#xD;
      hemorrhage rates seem to be higher in &quot;hot&quot; techniques.&#xD;
&#xD;
      LigaSure® is a bipolar &quot;current-carrying&quot; device, which is able to seal vessels.&#xD;
      Simultaneously tissue impedance is measured to control energy application. In this way only&#xD;
      the required energy levels are applied. Therefore LigaSure® can also be referred as a&#xD;
      &quot;softened hot&quot; technique.&#xD;
&#xD;
      In 2005 Lachanas et al. compared the LigaSure®-technique with the &quot;cold&quot; steel technique in&#xD;
      200 patients and found significantly less postoperative pain in favor of the&#xD;
      LigaSure®-technique. Postoperative hemorrhage rates were not higher with LigaSure®. Based on&#xD;
      the LigaSure®-scissors, Medtronic introduced a device specifically developed and licensed for&#xD;
      tonsillectomies (BiZactTM).&#xD;
&#xD;
      Aim of this study will be the evaluation of handling, surgical time, postoperative pain and&#xD;
      postoperative hemorrhage rates in comparison to traditional techniques on the contralateral&#xD;
      side. In one patient, two different techniques will be used. This side-controlled evaluation&#xD;
      of surgical techniques in tonsillectomies has been proven successfully in previous studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">December 21, 2020</completion_date>
  <primary_completion_date type="Actual">October 23, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients will not be informed which side was operated with the BiZact™ device. Surgeons however inevitably know side. The side will also be documented in the surgical report. Follow-up specialists must refrain from reading through surgical reports, thus not know which technique was used for which side. Discharging letters will not include technique information.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>surgical time</measure>
    <time_frame>1 hour (intraoperative)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to stop bleeding</measure>
    <time_frame>1 hour (intraoperative)</time_frame>
    <description>Time to stop bleeding per side after tonsil removal (recorded by theatre staff - stopwatch)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative blood loss</measure>
    <time_frame>1 hour (intraoperative)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain assessment</measure>
    <time_frame>Day of surgery until 2 months after surgery</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>approx. 10 days after surgery</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tonsil mobility intraoperatively</measure>
    <time_frame>intraoperative</time_frame>
    <description>Tonsil mobility intraoperatively on a VAS-Scales for each side (from 0 not mobile to 100mm very easy to move)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Tonsillitis Chronic</condition>
  <condition>Tonsillectomy</condition>
  <condition>Hemorrhage</condition>
  <condition>Postoperative Pain</condition>
  <condition>Postoperative Hemorrhage</condition>
  <condition>Surgery--Complications</condition>
  <condition>Handling</condition>
  <condition>Otorhinolaryngologic Diseases</condition>
  <arm_group>
    <arm_group_label>BiZact™ device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BiZact™ device will be used appropriately to its purpose to remove one tonsil by:&#xD;
Incision of the anterior palatal arch&#xD;
Locating of the cranial pole of the tonsil&#xD;
Dissection of the tonsil capsule&#xD;
Localized coagulation of bleeding vessels&#xD;
Detaching of the inferior pole from the pharynx tissue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cold steel dissection (CD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiZactTM Open Sealer/Divider</intervention_name>
    <description>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.</description>
    <arm_group_label>BiZact™ device</arm_group_label>
    <arm_group_label>Cold steel dissection (CD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 14 and older&#xD;
&#xD;
          -  Written informed consent (in case of underage participant also parental informed&#xD;
             consent)&#xD;
&#xD;
          -  Assigned for Tonsillectomy on both sides due to chronic tonsillitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of abscesses in tonsillar region&#xD;
&#xD;
          -  Coagulation disorder (as assessed by a coagulation questionnaire and blood results)&#xD;
&#xD;
          -  Suspicion of untreated malignancy of any kind&#xD;
&#xD;
          -  Planned removal of only one tonsil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <reference>
    <citation>Österreichische Gesellschaften für Hals-Nasen-Ohren-Heilkunde, Kopf- und Halschirurgie und Kinder- und Jugendheilkunde. Joint recommendation on tonsillectomy. Monatsschrift Kinderheilkunde. 2008;156(3):268-271.</citation>
  </reference>
  <reference>
    <citation>Lowe D, van der Meulen J. National Prospective Tonsillectomy Audit. Bulletin of The Royal College of Surgeons of England. 2003;85(10):352-353.</citation>
  </reference>
  <reference>
    <citation>Sarny S, Habermann W, Ossimitz G, Schmid C, Stammberger H. Tonsilar haemorrhage and re-admission: a questionnaire based study. Eur Arch Otorhinolaryngol. 2011 Dec;268(12):1803-7. doi: 10.1007/s00405-011-1541-y. Epub 2011 Mar 4.</citation>
    <PMID>21373896</PMID>
  </reference>
  <reference>
    <citation>Dadgarnia MH, Aghaei MA, Atighechi S, Behniafard N, Vahidi MR, Meybodian M, Zand V, Vajihinejad M, Ansari A. The comparison of bleeding and pain after tonsillectomy in bipolar electrocautery vs cold dissection. Int J Pediatr Otorhinolaryngol. 2016 Oct;89:38-41. doi: 10.1016/j.ijporl.2016.07.022. Epub 2016 Jul 26.</citation>
    <PMID>27619026</PMID>
  </reference>
  <reference>
    <citation>Riegler M, Cosentini E. Aktueller Stand der LigaSure®/Atlas®-Technologie zur Gefäßversiegelung in der Allgemeinchirurgie. European Surgery. 2004;36(2):85-88.</citation>
  </reference>
  <reference>
    <citation>Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. doi: 10.1097/01.mlg.0000172044.57285.b6.</citation>
    <PMID>16148700</PMID>
  </reference>
  <reference>
    <citation>Izny Hafiz Z, Rosdan S, Mohd Khairi MD. Coblation tonsillectomy versus dissection tonsillectomy: a comparison of intraoperative time, intraoperative blood loss and post-operative pain. Med J Malaysia. 2014 Apr;69(2):74-8.</citation>
    <PMID>25241816</PMID>
  </reference>
  <reference>
    <citation>Chettri ST, Bhandary S, Nepal A, et al. A single blind controlled study comparing bipolar elecrocautery tonsillectomy to cold dissection method in pediatric age groups. Health Renaissance. 2014;11(3):270-272.</citation>
  </reference>
  <reference>
    <citation>Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.</citation>
    <PMID>11733293</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 2, 2021</last_update_submitted>
  <last_update_submitted_qc>January 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Assoc. Prof. PD Dr. Gregor Heiduschka</investigator_full_name>
    <investigator_title>Assoc. Prof. PD M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillitis</mesh_term>
    <mesh_term>Otorhinolaryngologic Diseases</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Postoperative Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>individual participant data (IPD) is not to be shared with third party members</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793816
org study id: EK Nr: 1399/2018
nct id: NCT03793816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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).
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients will not be informed which side was operated with the BiZact™ device. Surgeons however inevitably know side. The side will also be documented in the surgical report. Follow-up specialists must refrain from reading through surgical reports, thus not know which technique was used for which side. Discharging letters will not include technique information.
measure: surgical time
time frame: 1 hour (intraoperative)
description: 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).
measure: Time to stop bleeding
time frame: 1 hour (intraoperative)
description: Time to stop bleeding per side after tonsil removal (recorded by theatre staff - stopwatch)
measure: intraoperative blood loss
time frame: 1 hour (intraoperative)
description: 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)
measure: Postoperative pain assessment
time frame: Day of surgery until 2 months after surgery
description: 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.
measure: Wound healing
time frame: approx. 10 days after surgery
description: 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)
measure: Tonsil mobility intraoperatively
time frame: intraoperative
description: Tonsil mobility intraoperatively on a VAS-Scales for each side (from 0 not mobile to 100mm very easy to move)
arm group label: BiZact™ device
arm group type: Active Comparator
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
arm group label: Cold steel dissection (CD)
arm group type: Active Comparator
description: Cold steel dissection (CD) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).
intervention type: Device
intervention name: BiZactTM Open Sealer/Divider
description: 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.
arm group label: BiZact™ device
arm group label: Cold steel dissection (CD)
criteria: 
gender: All
minimum age: 14 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Austria
citation: Österreichische Gesellschaften für Hals-Nasen-Ohren-Heilkunde, Kopf- und Halschirurgie und Kinder- und Jugendheilkunde. Joint recommendation on tonsillectomy. Monatsschrift Kinderheilkunde. 2008;156(3):268-271.
citation: Lowe D, van der Meulen J. National Prospective Tonsillectomy Audit. Bulletin of The Royal College of Surgeons of England. 2003;85(10):352-353.
citation: Sarny S, Habermann W, Ossimitz G, Schmid C, Stammberger H. Tonsilar haemorrhage and re-admission: a questionnaire based study. Eur Arch Otorhinolaryngol. 2011 Dec;268(12):1803-7. doi: 10.1007/s00405-011-1541-y. Epub 2011 Mar 4.
PMID: 21373896
citation: Dadgarnia MH, Aghaei MA, Atighechi S, Behniafard N, Vahidi MR, Meybodian M, Zand V, Vajihinejad M, Ansari A. The comparison of bleeding and pain after tonsillectomy in bipolar electrocautery vs cold dissection. Int J Pediatr Otorhinolaryngol. 2016 Oct;89:38-41. doi: 10.1016/j.ijporl.2016.07.022. Epub 2016 Jul 26.
PMID: 27619026
citation: Riegler M, Cosentini E. Aktueller Stand der LigaSure®/Atlas®-Technologie zur Gefäßversiegelung in der Allgemeinchirurgie. European Surgery. 2004;36(2):85-88.
citation: Lachanas VA, Prokopakis EP, Bourolias CA, Karatzanis AD, Malandrakis SG, Helidonis ES, Velegrakis GA. Ligasure versus cold knife tonsillectomy. Laryngoscope. 2005 Sep;115(9):1591-4. doi: 10.1097/01.mlg.0000172044.57285.b6.
PMID: 16148700
citation: Izny Hafiz Z, Rosdan S, Mohd Khairi MD. Coblation tonsillectomy versus dissection tonsillectomy: a comparison of intraoperative time, intraoperative blood loss and post-operative pain. Med J Malaysia. 2014 Apr;69(2):74-8.
PMID: 25241816
citation: Chettri ST, Bhandary S, Nepal A, et al. A single blind controlled study comparing bipolar elecrocautery tonsillectomy to cold dissection method in pediatric age groups. Health Renaissance. 2014;11(3):270-272.
citation: Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
PMID: 11733293
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Assoc. Prof. PD Dr. Gregor Heiduschka
investigator title: Assoc. Prof. PD M.D.
mesh term: Tonsillitis
mesh term: Otorhinolaryngologic Diseases
mesh term: Hemorrhage
mesh term: Postoperative Hemorrhage
sharing ipd: No
ipd description: individual participant data (IPD) is not to be shared with third party members