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Comparison of Bizact With Electroscissor for Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03854279
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Johan C Ræder, Oslo University Hospital

Brief Summary:
In a randomized, partly double-blind prospective setup we want to compare traditional adult electro-scissor tonsillectomy With ultrasound Technology, Bizact.

Condition or disease Intervention/treatment Phase
Tonsillar Hypertrophy, Tonsillitis Device: tonsillar dissection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bizact Versus Electroscissor for Adult Tonsillectomy
Actual Study Start Date : February 20, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arm Intervention/treatment
Experimental: Bizact
Tonsillectomy will be done With the Bizact device
Device: tonsillar dissection
The tonsils will be removed by bizact device

Active Comparator: Electro-scissor
Tonsillectomy will be done With electro-scissors
Device: tonsillar dissection
The tonsils will be removed by bizact device




Primary Outcome Measures :
  1. Postoperative pain: Number of days With need of analgesics [ Time Frame: 2 weeks ]
    Number of days With need of analgesics


Secondary Outcome Measures :
  1. Postoperative pain: Dose need of pain killers during first 24 hr postoperatively [ Time Frame: 24 hrs ]
    Dose need of pain killers during first 24 hr postoperatively

  2. Postoperative bleeding [ Time Frame: 2 weeks ]
    Incidence of bleeding after discharge

  3. Per-operative bleeding [ Time Frame: per-operative ]
    Amount of bleeding during surgery

  4. Duration of surgery [ Time Frame: 0 - 1 hr ]
    time from start of surgery to end



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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned elective tonsillectomy
  • informed consent

Exclusion Criteria:

  • regular use of analgesics pre-operatively
  • known tendency of bleeding
  • not able to communicate in Norwegian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03854279


Contacts
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Contact: Johan Raeder, PhD 004722119690 johan.rader@medisin.uio.no

Locations
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Norway
Dept of Anesthesiology, Oslo University Hospital, Ullevaal Recruiting
Oslo, Norway, 0407
Contact: Johan Rader, PhD    004792249669    johan.rader@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
Medtronic

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Responsible Party: Johan C Ræder, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03854279     History of Changes
Other Study ID Numbers: Bizact study
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertrophy
Tonsillitis
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases