An interventional study of BiZactTM Open Sealer/Divider in Tonsillitis Chronic, Tonsillectomy and Hemorrhage, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 14 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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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.
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.
135 studies on the registry are indexed under Postoperative Hemorrhage; 31 are open to participants now.
This study's enrollment of 48 is below the median of 100 across 102 interventional studies indexed under Postoperative Hemorrhage.
Browse Postoperative Hemorrhage studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
Compared within Postoperative Hemorrhage, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hemorrhage. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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) with localized cauterization for hemostasis serves as the comparative procedure within each patient (cross-over).
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.
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).
Time frame: 1 hour (intraoperative)
Time to stop bleeding
Time to stop bleeding per side after tonsil removal (recorded by theatre staff - stopwatch)
Time frame: 1 hour (intraoperative)
intraoperative blood loss
intraoperative blood loss as measured by A) secretion/blood volume in suction device side separately B) number of used swabs C) swab weight (documented by surgical assistant, side separately at the earliest time point after removal out of the oral cavity - weighing scale provided only for this investigation)
Time frame: 1 hour (intraoperative)
Postoperative pain assessment
Postoperative pain assessment A) using a side specific questionnaire (visual analogue scales (VAS-Scale) 0-100mm: differences of more than 16mm can be judged as significant in style of Bijur et al. 2001) on days 0, 1, 3, 5, 7 and 10. B) follow-up phone call 2 months after surgery (or in-visit as preferred by the patient) assesses for swallowing difficulties and residual pain in side comparison.
Time frame: Day of surgery until 2 months after surgery
Wound healing
Wound healing on a VAS-Scales for each side (from 0 very nice tissue / no inflammation to 100mm scale very thick fibrin / strong inflammation as seen by redness/secretion) (evaluated by ENT specialist not familiar with previous randomized side in course of postoperative follow-up visit including review of histological findings)
Time frame: approx. 10 days after surgery
Tonsil mobility intraoperatively
Tonsil mobility intraoperatively on a VAS-Scales for each side (from 0 not mobile to 100mm very easy to move)
Time frame: intraoperative
Plan to share: No — individual participant data (IPD) is not to be shared with third party members
Ran from Sep 2019 to primary completion in Oct 2020, 13 months.
Of 35 non-industry interventional studies with no phase under Postoperative Hemorrhage, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 13 months is close to that.
Counting every sponsor, half of 38 studies reached it within 14 months; a quarter within 8 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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