Feasibility of Radiofrequency Resection in Oropharyngeal Tumor Surgery
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
調査の概要
状態
詳細な説明
In the last years radiofrequency resection has become a frequent method in surgical subspecialties. Although many departments are using this method for the resection of Tumor in the oropharynx, there is no study so far which describes feasibility and safety.
Goal of this study is to show feasibility and safety of Radiofrequency Resection in Oropharyngeal Tumor Surgery.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Bayern
-
Munich、Bayern、ドイツ、81675
- Department of Ear Nose Throat
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 18 years and older benign or malign tumor of the oropharynx tumor must be resectable transorally
Exclusion Criteria:
- Prior radiotherapy or chemotherapy
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients with benign or malign tumor in the oropharynx
Patient of 18 years and older with benign or malign tumor in the oropharynx.
The resection is done transorally by radiofrequency
|
Patient of 18 years and older with benign or malign tumor in the oropharynx.
The resection is done transorally by radiofrequency
|
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 |
|---|---|---|
|
total blood loss,
時間枠：intraoperative
|
assessing the blood loss by measuring blood in the suction
|
intraoperative
|
|
tissuesticking
時間枠：intraoperative
|
tissuesticking by physician global assessment scale from 1 - 6
|
intraoperative
|
|
coagulation
時間枠：intraoperative
|
coagulation by physician global assessment scale from 1 - 6,
|
intraoperative
|
|
Duration of Operation
時間枠：intraoperative
|
measuring Duration of Operation in minutes
|
intraoperative
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Zone of coagulation
時間枠：within one month after the operation
|
Zone of coagulation to assess the tissue damage by radiofrequency by a scale 1 - 6,
|
within one month after the operation
|
|
postoperative parameters
時間枠：within one month after the operations
|
woundhealing by Parameters normal, delayed, infection;
|
within one month after the operations
|
|
postoperative pain
時間枠：within one month after the operations
|
postoperative pain by visual analog scale from 0 -10,
|
within one month after the operations
|
|
accuracy of section
時間枠：within one month after the operations
|
accuracy of section assessed by a scale from 1 - 6
|
within one month after the operations
|
|
status of resection
時間枠：within one month after the operations
|
assessment of status of resection by assessing the margins of resection for Tumor scale from 1 - 6,
|
within one month after the operations
|
|
postoperative dysfunctions by descriptive name of scale
時間枠：within one month after the operations
|
postoperative dysfunctions by descriptive scale from 1 -10
|
within one month after the operations
|
協力者と研究者
捜査官
- 主任研究者：Clemens Heiser, MD、department for ENT, Klinikum Rechts der Isar der Technischen Universität München, Ismaninger Straße 22, 81675 München, Germany
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
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。