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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Punjab Province
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Dera Ghazi Khan、Punjab Province、パキスタン、32200
- Allama Iqbal Teaching Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Cold Steel Dissection Tonsillectomy
Participants randomized to this arm will undergo conventional 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.
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Score
時間枠：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.
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From surgery (day of tonsillectomy) to three (03) days postoperatively
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Operative Time
時間枠：During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
|
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
時間枠：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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協力者と研究者
捜査官
- スタディチェア：Sharbaz H Khosa, FCPS、Allama Iqbal Teaching Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- U1111-1342-4276
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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