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

NCT03793816 | Completed

• 1 other identifier: EK Nr: 1399/2018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to stop bleeding

  1 hour (intraoperative)

• intraoperative blood loss

  1 hour (intraoperative)

• Postoperative pain assessment

  Day of surgery until 2 months after surgery

• Wound healing

  approx. 10 days after surgery

• Tonsil mobility intraoperatively

  intraoperative

Study Arms (2)

BiZact™ device

ACTIVE COMPARATOR

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

Cold steel dissection (CD)

ACTIVE COMPARATOR

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

Device: BiZactTM Open Sealer/Divider

Interventions

BiZactTM Open Sealer/Divider 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.

BiZact™ device; Cold steel dissection (CD)

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (10)

• 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.

  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.

  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.

  PMID: 21373896 BACKGROUND

• 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 BACKGROUND

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

  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.

  PMID: 16148700 BACKGROUND

• 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 BACKGROUND

• 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.

  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.

  PMID: 11733293 BACKGROUND

• 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.

  PMID: 34338876 DERIVED

MeSH Terms

Conditions

Hemorrhage; Pain, Postoperative; Postoperative Hemorrhage; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD M.D.

Model Details: 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).

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 4, 2019
• Study Start: September 1, 2019
• Primary Completion: October 23, 2020
• Study Completion: December 21, 2020
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)