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

NCT ID: NCT03793816

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-12-21

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

BiZactTM Open Sealer/Divider

Intervention Type: DEVICE

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.

Cold steel dissection (CD)

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

Group Type: ACTIVE_COMPARATOR

BiZactTM Open Sealer/Divider

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Assoc. Prof. PD Dr. Gregor Heiduschka

Assoc. Prof. PD M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

Lowe D, van der Meulen J. National Prospective Tonsillectomy Audit. Bulletin of The Royal College of Surgeons of England. 2003;85(10):352-353.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 21373896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27619026 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 16148700 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25241816 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 11733293 (View on PubMed)

Besser G, Grasl S, Meyer EL, Schnoell J, Bartosik TJ, Brkic FF, Heiduschka G. A novel electrosurgical divider: performance in a self-controlled tonsillectomy study. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):2109-2115. doi: 10.1007/s00405-021-07008-9. Epub 2021 Aug 2.

Reference Type: DERIVED

PMID: 34338876 (View on PubMed)

Other Identifiers

EK Nr: 1399/2018

Identifier Type: -

Identifier Source: org_study_id