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Study Comparing Harmonic Scalpel and Conventional Cold Steel Tonsil Removal Surgery in Children Requiring Tonsillectomy

NCT07656831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-06-18

No results posted yet for this study

Summary

This clinical trial aims to compare two commonly used methods of tonsil removal surgery (tonsillectomy) in children and adults with chronic tonsillitis. Chronic tonsillitis refers to repeated episodes of tonsil infection that occur frequently over several years and require surgical removal of the tonsils.

The main question this study aims to answer is:

Does tonsillectomy performed with a harmonic scalpel result in less pain three days after surgery compared with the conventional cold steel dissection technique?

Researchers will also compare:

How long the surgery takes to perform How much blood is lost during the operation The level of pain experienced three days after surgery

A total of 66 participants aged 5 to 45 years who are scheduled for tonsillectomy because of chronic tonsillitis will take part in the study. Participants will be randomly assigned to undergo either conventional cold steel dissection tonsillectomy or harmonic scalpel tonsillectomy.

All surgeries will be performed by experienced ENT surgeons following standard hospital procedures. After surgery, participants will receive routine medications and instructions for home care. They will be followed for three days and then return to the ENT clinic for assessment of pain and examination of the healing of the surgical site.

The study hypothesis is that patients undergoing harmonic scalpel tonsillectomy will experience less pain three days after surgery than those undergoing conventional cold steel dissection tonsillectomy.

Conditions

  • Chronic Tonsillitis

Interventions

PROCEDURE

Cold Steel Dissection Tonsillectomy

The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol.

PROCEDURE

Harmonic Scalpel Tonsillectomy

A harmonic scalpel with a curved blade (Ethicon Endosurgery, Johnson \& Johnson, USA) will be used for dissection and hemostasis (using ultrasonic energy) during tonsil removal.

Sponsors & Collaborators

  • Allama Iqbal Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Sharbaz H Khosa, FCPS · Allama Iqbal Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-03-30
Completion
2026-03-30

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07656831 on ClinicalTrials.gov