Endoscopic Versus Conventional Parotidectomy for Benign Parotid Tumors (miniparo)
Endoscopic Versus Conventional Parotidectomy in the Management of Benign Parotid Tumors : A Prospective Comparative Study
調査の概要
状態
条件
詳細な説明
Parotid gland tumors account for approximately 3-6% of all head and neck tumors, and nearly 70-80% arise from the superficial lobe of the gland, with the majority being benign lesions such as pleomorphic adenoma and Warthin tumor . A considerable proportion of these tumors occur in the inferior pole of the parotid gland, where surgical management aims to achieve complete tumor excision while preserving facial nerve function and maintaining satisfactory cosmetic outcomes .
Conventional parotidectomy performed through a modified Blair incision remains the standard surgical approach for benign parotid tumors . This technique offers adequate surgical exposure and good tumor control; however, it is associated with several limitations including visible facial scarring, potential facial nerve injury, Frey's syndrome, and postoperative sensory disturbances .
In recent years, minimally invasive surgical approaches have been introduced to overcome these limitations. Endoscopic parotidectomy has emerged as a promising technique for selected benign parotid tumors. The magnified endoscopic view may facilitate more precise dissection and improved identification of facial nerve branches while allowing smaller incisions and potentially better cosmetic outcomes .
Despite encouraging results reported in several studies, the available evidence comparing endoscopic parotidectomy with the conventional approach remains limited. Therefore, further prospective comparative studies are required to evaluate the safety, efficacy, and cosmetic advantages of this minimally invasive technique.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Asyut、エジプト、2063045
- Department of General Surgery, Maxillofacial and Head and Neck Unit
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 years or older
- Patients with benign parotid tumors involving the superficial lobe of the parotid gland
- Tumors located in the inferior pole with or without limited deep lobe extension
- Tumor size suitable for minimally invasive approach ≤4 cm
- Patients fit for surgery under general anesthesia
- Patients willing to provide informed consent and comply with follow-up
Exclusion Criteria:
- Recurrent parotid tumors
- Previous parotid surgery on the affected side
- Pre-existing facial nerve dysfunction
- Previous neck surgery or extensive cervical/anterior chest wall scarring
- Significant comorbidities contraindicating surgery or general anesthesia
- Suspected or confirmed malignant parotid tumors
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Endoscopic Parotidectomy Group
Experimental Arm Endoscopic Parotidectomy
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Minimally invasive endoscopic-assisted parotidectomy performed through anterior chest wall approach for benign parotid tumors.
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アクティブコンパレータ：Conventional Open Parotidectomy Group
Conventional Parotidectomy
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Conventional open parotidectomy performed through modified Blair incision for management of benign parotid tumors.
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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 |
|---|---|---|
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Surgical safety and feasibility
時間枠：During surgery and up to 3 months postoperatively.
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Assessment of intraoperative and postoperative complications and conversion rate to open surgery.
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During surgery and up to 3 months postoperatively.
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Facial nerve function
時間枠：24 hours, 1 week, 1 month, and 3 months postoperatively.
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Assessment using House-Brackmann grading system.
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24 hours, 1 week, 1 month, and 3 months postoperatively.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Intraoperative blood loss
時間枠：Intraoperative
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Intraoperative
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- endo-parotidectomy
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?
IPD プランの説明
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Endoscopic Parotidectomy Groupの臨床試験
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Riphah International Universityまだ募集していません
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Riphah International Universityまだ募集していません
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Mansoura Universityまだ募集していません
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University Hospital, GhentUniversity Ghent募集