Chronic Tonsillitis
Conditions
Keywords
Tonillectomy, Harmonic Scalpel, Cold Steel Dissection, Postoperative Pian, Intraoperative Blood Loss, Operative time, Chronic Recurrent Tonsillitis
Brief 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.
Interventions
PROCEDURECold 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.
PROCEDUREHarmonic 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
Allama Iqbal Teaching Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* chronic tonsillitis and planned for tonsillectomy
Exclusion criteria
* Upper respiratory tract infection within preceding three weeks * Peritonsillar abscess or history of quinsy * Known bleeding disorder (hemophilia, thrombocytopenia) or on anticoagulant therapy * Craniofacial anomalies or syndromic conditions affecting airway or surgical anatomy * Uncontrolled diabetes, severe cardiopulmonary disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | From surgery (day of tonsillectomy) to three (03) days postoperatively | Postoperative pain will be assessed three days after tonsillectomy using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst tolerable pain. Mean VAS scores will be compared between the harmonic scalpel and cold steel dissection groups. |
Countries
Pakistan
Contacts
STUDY_CHAIRSharbaz H Khosa, FCPS
Allama Iqbal Teaching Hospital
Outcome results
None listed