Bizact Tonsillectomy: Postoperative Pain, Bleeding and Cost-effectiveness (Randomized Study)

Helsinki University Central Hospital224 enrolled

Overview

Randomized trial assessing Bizact-instrument in tonsillectomy and it's impact on postoperative recovery (pain, hemorrhage)

Bizact is an electrosurgical instrument developed for tonsillectomy. Bizact causes less thermal damage to tissues than traditional bipolar coagulation, and thus is assumed, that using Bizact might lead to faster and less painful recovery. Furthermore, incidence of postoperative hemorrhage is assumed to be lower. The study evaluates the usability of Bizact and it's impact on postoperative pain, the occurrence of secondary postoperative hemorrhage, and the total costs of surgery compared with traditional bipolar tonsillectomy. We recruit 225 patients who are randomized into three groups. 1. both tonsils are removed with Bizact 2. both tonsils are removed with traditional method using bipolar cautery and scissors 3. one tonsil is removed with Bizact ant the other with bipolar cautery and scissors Patients are blinded with respect to group. Postoperative recovery is monitored on a daily basis with a questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

224

Conditions

ENT Disease Tonsil Disease Surgery

Interventions

TonsillectomyDEVICE

Tonsillectomy is performed with Bizact®, or bipolar cautery and scissors, or both

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Tonsillectomy due to chronic tonsillitis or tonsillar hypertrophy * Age ≥18 years Exclusion Criteria: * Unilateral tonsillectomy * History of peritonsillar abscess * Coagulation disorder or ongoing anticoagulation therapy * Re-tonsillectomy * Additional simultaneous procedure

Locations (1)

Helsinki University Hospital

Helsinki, Helsinki, Finland

Outcomes

Primary Outcomes

Patient reported intensity of postoperative pain in numeric rating scale (0-10) on postoperative days 1-14

Patients receive a questionnaire to assess their recovery during the first 14 postoperative days. Pain is evaluated separately for each side every morning before taking any analgesics and reported using a numeric rating scale 0-10.

Time frame: within 2 weeks after surgery

Secondary Outcomes

Usage of pain medication

Patients document their daily use of pain medication in the postoperative questionnaire.

Time frame: 14 days postoperatively

Incidence of primary hemorrhage

Incidence of postoperative hemorrhage within 24 hours of surgery

Time frame: 24 hours postoperatively

Incidence of secondary hemorrhage

Incidence of secondary postoperative hemorrhage warranting hospital contact and confirmed by an examination, graded by severity according to the Stammberger classification.

Time frame: from 24 hours to 14 days postoperatively

Data from ClinicalTrials.gov

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