NCT03793816

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 14 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-10-23
• Completion: 2020-12-21
• First posted: 2019-01-04
• Last updated: 2021-01-05

Locations

1 site across 1 country: Austria