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Comparison of Bizact With Electroscissor for Tonsillectomy

Primary Purpose

Tonsillar Hypertrophy, Tonsillitis

Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
tonsillar dissection
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillar Hypertrophy, Tonsillitis

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Anesthesiology, Oslo University Hospital, UllevaalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bizact

Electro-scissor

Arm Description

Tonsillectomy will be done With the Bizact device

Tonsillectomy will be done With electro-scissors

Outcomes

Primary Outcome Measures

Postoperative pain: Number of days With need of analgesics
Number of days With need of analgesics

Secondary Outcome Measures

Postoperative pain: Dose need of pain killers during first 24 hr postoperatively
Dose need of pain killers during first 24 hr postoperatively
Postoperative bleeding
Incidence of bleeding after discharge
Per-operative bleeding
Amount of bleeding during surgery
Duration of surgery
time from start of surgery to end

Full Information

First Posted
February 23, 2019
Last Updated
February 25, 2019
Sponsor
Oslo University Hospital
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT03854279
Brief Title
Comparison of Bizact With Electroscissor for Tonsillectomy
Official Title
Bizact Versus Electroscissor for Adult Tonsillectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillar Hypertrophy, Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bizact
Arm Type
Experimental
Arm Description
Tonsillectomy will be done With the Bizact device
Arm Title
Electro-scissor
Arm Type
Active Comparator
Arm Description
Tonsillectomy will be done With electro-scissors
Intervention Type
Device
Intervention Name(s)
tonsillar dissection
Intervention Description
The tonsils will be removed by bizact device
Primary Outcome Measure Information:
Title
Postoperative pain: Number of days With need of analgesics
Description
Number of days With need of analgesics
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Postoperative pain: Dose need of pain killers during first 24 hr postoperatively
Description
Dose need of pain killers during first 24 hr postoperatively
Time Frame
24 hrs
Title
Postoperative bleeding
Description
Incidence of bleeding after discharge
Time Frame
2 weeks
Title
Per-operative bleeding
Description
Amount of bleeding during surgery
Time Frame
per-operative
Title
Duration of surgery
Description
time from start of surgery to end
Time Frame
0 - 1 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johan Raeder, PhD
Phone
004722119690
Email
johan.rader@medisin.uio.no
Facility Information:
Facility Name
Dept of Anesthesiology, Oslo University Hospital, Ullevaal
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johan Rader, PhD
Phone
004792249669
Email
johan.rader@medisin.uio.no

12. IPD Sharing Statement

Learn more about this trial

Comparison of Bizact With Electroscissor for Tonsillectomy

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