An interventional study of Tonsillectomy in ENT Disease, Tonsil Disease and Surgery, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage)
Bizact is an electrosurgical instrument developed for tonsillectomy. Bizact causes less thermal damage to tissues than traditional bipolar coagulation, and thus is assumed, that using Bizact might lead to faster and less painful recovery. Furthermore, incidence of postoperative hemorrhage is assumed to be lower.
The study evaluates the usability of Bizact and it's impact on postoperative pain, the occurrence of secondary postoperative hemorrhage, and the total costs of surgery compared with traditional bipolar tonsillectomy.
We recruit 225 patients who are randomized into three groups.
63 studies on the registry are indexed under Otorhinolaryngologic Diseases; 9 are open to participants now.
This study's enrollment of 224 is above the median of 72 across 50 interventional studies indexed under Otorhinolaryngologic Diseases.
Browse Otorhinolaryngologic Diseases studies →Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Patients operated with Bizact® instrument
Device: Tonsillectomy
Patient operated with conventional technique (bipolar cautery and scissors)
Device: Tonsillectomy
Side-controlled group, in which one tonsil is operated with Bizact® and another with conventional technique (bipolar cautery and scissors)
Device: Tonsillectomy
Tonsillectomy is performed with Bizact®, or bipolar cautery and scissors, or both
Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14
Patients receive a questionnaire to assess their recovery during the first 14 postoperative days. Pain is evaluated separately for each side every morning before taking any analgesics and reported using a numeric rating scale 0-10.
Time frame: within 2 weeks after surgery
Usage of pain medication
Patients document their daily use of pain medication in the postoperative questionnaire.
Time frame: 14 days postoperatively
Incidence of primary hemorrhage
Incidence of postoperative hemorrhage within 24 hours of surgery
Time frame: 24 hours postoperatively
Incidence of secondary hemorrhage
Incidence of secondary postoperative hemorrhage warranting hospital contact and confirmed by an examination, graded by severity according to the Stammberger classification.
Time frame: from 24 hours to 14 days postoperatively
Ran from Mar 2021 to primary completion in Oct 2024, 43 months.
Of 20 interventional studies with no phase under Otorhinolaryngologic Diseases, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's 43 months is above that.
Otorhinolaryngologic Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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