Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial
CompletedNot applicableNCT03793816
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Tonsillectomy Using BiZact™ - a Randomized Side-controlled Clinical Trial
- Conditions
- Tonsillitis Chronic
- Tonsillectomy
- Hemorrhage
- Postoperative Pain
- Postoperative Hemorrhage
- Surgery--Complications
- Handling
- Otorhinolaryngologic Diseases
- Interventions
- Device: BiZactTM Open Sealer/Divider
- Sponsor
- Medical University of Vienna
- Start date
- 2019-09-01
- Primary completion
- 2020-10-23
- Sex
- All
- Age range
- from 14 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- Austria
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03793816