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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793816
• Other study ID #: EK Nr: 1399/2018
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 21, 2020

Study information

• Verified date: January 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 21, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (9)

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. — View 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.

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. — View 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. — View 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. — View 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.

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.

Riegler M, Cosentini E. Aktueller Stand der LigaSure®/Atlas®-Technologie zur Gefäßversiegelung in der Allgemeinchirurgie. European Surgery. 2004;36(2):85-88.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to stop bleeding	Time to stop bleeding per side after tonsil removal (recorded by theatre staff - stopwatch)	1 hour (intraoperative)
Secondary	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)
Secondary	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
Secondary	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
Secondary	Tonsil mobility intraoperatively	Tonsil mobility intraoperatively on a VAS-Scales for each side (from 0 not mobile to 100mm very easy to move)	intraoperative