Study Comparing Harmonic Scalpel and Conventional Cold Steel Tonsil Removal Surgery in Children Requiring Tonsillectomy
Comparison of Harmonic Scalpel Versus Cold Steel Dissection Tonsillectomy in Children
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Punjab Province
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Dera Ghazi Khan、Punjab Province、巴基斯坦、32200
- Allama Iqbal Teaching Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Cold Steel Dissection Tonsillectomy
Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy.
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The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol.
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实验性的：Harmonic Scalpel Tonsillectomy
Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Pain Score
大体时间：From surgery (day of tonsillectomy) to three (03) days postoperatively
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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.
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From surgery (day of tonsillectomy) to three (03) days postoperatively
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Operative Time
大体时间：During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
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Duration of surgery measured in minutes from the start of tonsil dissection to completion of surgery and achievement of hemostasis.
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During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
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Intraoperative Blood Loss
大体时间：During the surgical procedure (from start of dissection to completion of hemostasis).
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Blood loss measured in milliliters using suction canister and pre-weighed sponges (1 g increase = 1 mL blood).
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During the surgical procedure (from start of dissection to completion of hemostasis).
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合作者和调查者
调查人员
- 学习椅：Sharbaz H Khosa, FCPS、Allama Iqbal Teaching Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- U1111-1342-4276
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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