Outcomes of Bipolar Electrocautery Tonsillectomy Versus Cold Steel Dissection Pediatric Tonsillectomy

Not Applicable

Completed

• Conditions: Tonsillitis
• Interventions: Procedure: Bipolar electrocautery tonsillectomy technique; Procedure: Cold steel dissection technique

• Registration Number: NCT06494839
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

It was intended to practically establish whether or not the relatively newer technique of tonsillectomy like bipolar electrocautery tonsillectomy has any added benefits in reducing the duration of surgery, blood loss and post-operative pain as compared with conventional cold steel dissection method. This study was done to compare the outcomes of bipolar electrocautery tonsillectomy versus cold steel dissection pediatric tonsillectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients of 5-13 years of age
• Both genders
• With a history of recurrent episodes of tonsillitis in the last year
• Children who had bilaterally enlarged tonsils
• No history of fever or sore throat in the last 4 weeks

Exclusion Criteria

• Patients who had enlarged adenoids and required adenotonsillectomy
• Patients who underwent tonsillectomy after quinsy
• With a history of bleeding disorders
• Patients who showed an international normalized ratio (INR) ≥ 1.5

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar electrocautery tonsillectomy group	Bipolar electrocautery tonsillectomy technique	-
Cold steel dissection group	Cold steel dissection technique	-

Primary Outcome Measures

Name	Time	Method
Blood loss	up to 24 hours	Intraoperative blood loss was measured by reading the levels given in the suction bottle at the end of surgery. The weight of dry gauze was subtracted from the wet, considering 1g=1ml.
Postoperative pain	24 hours	Postoperative pain was measured at regular intervals (6-hourly till 24 hours) using the Wong-Baker faces pain rating scale.12 The Wong-Baker faces pain rating scale graded pain as mild (1-3), moderate (4-6), or severe (\>6).
Operative time	1 hour	Operative time was measured from the anterior pillar incision to the removal of the mouth gag.

Trial Locations

Locations (1)

Sir Ganga Ram Hospital; 🇵🇰 Lahore, Punjab, Pakistan