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

NCT03793816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-01-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-10-23
Completion
2020-12-21

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03793816 on ClinicalTrials.gov