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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold Steel Dissection Tonsillectomy | Active Comparator | Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy. |
|
| Harmonic Scalpel Tonsillectomy | Experimental | Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Steel Dissection Tonsillectomy | Procedure | The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Score | 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. | From surgery (day of tonsillectomy) to three (03) days postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Duration of surgery measured in minutes from the start of tonsil dissection to completion of surgery and achievement of hemostasis. | During the surgical procedure (from insertion of mouth gag to removal after hemostasis). |
| Intraoperative Blood Loss |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharbaz H Khosa, FCPS | Allama Iqbal Teaching Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allama Iqbal Teaching Hospital | Dera Ghazi Khan | Punjab Province | 32200 | Pakistan |
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| Harmonic Scalpel Tonsillectomy | Procedure | 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. |
|
Blood loss measured in milliliters using suction canister and pre-weighed sponges (1 g increase = 1 mL blood). |
| During the surgical procedure (from start of dissection to completion of hemostasis). |