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Comparison of Bizact With Electroscissor for Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03854279
Recruitment Status : Unknown
Verified February 2019 by Johan C Ræder, Oslo University Hospital.
Recruitment status was:  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

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
More Information
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Responsible Party: Johan C Ræder, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03854279    
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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Tonsillitis
Hypertrophy
Pathological Conditions, Anatomical
Pharyngitis
Respiratory Tract Infections
 Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases