Enhanced Recovery After Radical Cystectomy Study
調査の概要
詳細な説明
This is a prospective non randomized study of two cohorts, one defined by the usual protocol and the other one by the application of accelerated recovery protocol. It's discarded a priori a prospective randomized trial, since it does not seem feasible to avoid byass of control group when synchronizing the active intervention and control. Subjects surgery will be followed after discharge for a minimum of 90 days, and thereafter according to protocol of each center. Patients will be provided with a satisfaction survey 90 days after surgery.
The degree of compliance with the protocol will be assessed through a checklist indicating compliance with each of the steps of the protocol in both groups. All patients will sign an informed consent for the study authorizing the use of their clinical data for statistical analysis.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Madrid、スペイン
- Fundación Jiménez Díaz
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Madrid、スペイン
- Hospital Doce de Octubre
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Madrid、スペイン
- Hospital Infanta Leonor
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Madrid、スペイン
- Hospital Universitario Gregorio Maranon
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Madrid
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Alcalá de Henares、Madrid、スペイン
- Hospital Universitario Principe de Asturias
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Alcorcón、Madrid、スペイン
- Hospital Universitario Fundacion Alcorcon
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Getafe、Madrid、スペイン
- Hospital Universitario de Getafe
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Leganés、Madrid、スペイン
- Hospital Universitario Severo Ochoa
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Majadahonda、Madrid、スペイン
- Hospital Puerta de Hierro
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Móstoles、Madrid、スペイン
- Hospital Universitario Rey Juan carlos
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Torrejón de Ardoz、Madrid、スペイン
- Hospital Universitario de Torrejon
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Valdemoro、Madrid、スペイン
- Hospital Universitario Infanta Elena
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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:
- Consecutive patients scheduled for radical cystectomy in the participating hospitals
- Signed informed consent
Exclusion Criteria:
- Refusal to sign informed consent
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
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Control
Consecutive radical cystectomies up to 94 patients in 13 participating hospitals in Madrid, Spain.
These patients will be taken care of as it is done regularly in each of participating hospitals.
All study variables will be prospectively collected in this group
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Active Treatment
After recruiting cotrol group, another consecutive radical cystectomies up to 94 patients in 13 participating hospitals will be recruited and the following measures will be followed with them: I.-PREOPERATIVE MEASURES: (eight measures according to Protocol) II.- INTRAOPERATIVE MEASURES: (six measures according to Protocol) III.- POSTOPERATIVE MEASURES: (eight measures according to Protocol) |
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
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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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In-hospital length-of-stay (LOS), defined as the number of days since the admission of the patient to the hospital until the day of discharge, Morbidity of surgery. Categorized by the Clavien complications scale at 30-, 60- and 90-postoperative days
時間枠：5-40 days
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Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital.
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5-40 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mortality at 30-, 60- and 90- postoperative days
時間枠：90 days
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90 days
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30日再入院率
時間枠：30日
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30日
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Transfusion rate
時間枠：90 days
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90 days
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Patient satisfaction measured with the enclosed questionnaire
時間枠：90 days
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Do you know the names of your attending physician and nurse? The quality of the preoperative care and information has been: The quality of the postoperative care and information has been: Do you think that the information on the care of your urostomy has been enough? Yes/No If NO, on which of the following points would you have liked receiving more information? Types of collecting bags and accessories Stomal hygiene and change of bags Complications of the stoma and the surrounding skin Counseling on food habits, dress apparel, and physical and sexual activity Comunity counselling: Stoma therapist, patients associations If you had a neobladder performed, were you trained in self-catheterization ? How would you rate your motivation in learning the above mentioned issues? In all, the quality of the health care that you have received is: |
90 days
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Carlos Llorente, MD、Hospital Fundación de Alcorcón
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
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