Comparison of Bizact With Electroscissor for Tonsillectomy

Phase 4

• Conditions: Tonsillar Hypertrophy, Tonsillitis
• Interventions: Device: tonsillar dissection

• Registration Number: NCT03854279
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study Start: 2019-02-20
• Study First Submitted: 2019-02-23
• Study First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Study First Posted: 2019-02-26
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-10-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bizact	tonsillar dissection	Tonsillectomy will be done With the Bizact device
Electro-scissor	tonsillar dissection	Tonsillectomy will be done With electro-scissors

Primary Outcome Measures

Name	Time	Method
Postoperative pain: Number of days With need of analgesics	2 weeks	Number of days With need of analgesics

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding	2 weeks	Incidence of bleeding after discharge
Duration of surgery	0 - 1 hr	time from start of surgery to end
Postoperative pain: Dose need of pain killers during first 24 hr postoperatively	24 hrs	Dose need of pain killers during first 24 hr postoperatively
Per-operative bleeding	per-operative	Amount of bleeding during surgery

Trial Locations

Locations (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway