Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations (ORP-SAC)
Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
Radical prostatectomy has become the gold standard treatment for prostate cancer.
Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers around the world start to develop laparoscopic and robotic approach over the past years. The problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep learning curve with a high initial complication rate, and the use of robotic assistance surgery despite of lower learning curve is associated with higher surgical supply and operative room costs. These costs may have a significant impact on overall cost of prostate cancer care especially in Brazil.
In Brazil, the open route for radical prostatectomy is still the most frequent approach. One of the disadvantages of open prostatectomy from the other surgeries is the longest hospital stay. However, the question of what length of stay after this operation is optimal and necessary is unresolved. In this trial the investigators have compared a randomized group of patients that had discharged on postoperative day 2, 1 and same day surgery. The investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy (patient discharge in the same day of surgery - average 12 hours of hospitalization) maintaining patient satisfaction and safety.
調査の概要
状態
条件
詳細な説明
Radical prostatectomy initially described by Walsh (1982) has become the gold standard treatment for prostate cancer and has evolved enormously over the last 25 years. Improvements include the use of smaller incisions, reduced blood loss, shorter hospital stays, and surgical refinement. Several large series with long-term follow-up have confirmed that this approach results in excellent cancer control and functional results in terms of preservation of erectile potency and urinary continence.
Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers around the world start to develop laparoscopic and robotic approach over the past years. The problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep learning curve with a high initial complication rate, and the use of robotic assistance surgery despite of lower learning curve is associated with higher surgical supply and operative room costs. These costs may have a significant impact on overall cost of prostate cancer care especially in Brazil where nowadays only have 3 centers with 5 robots.
In Brazil, the open route for radical prostatectomy is still the most frequent approach, mainly out of large cities. One of the disadvantages of open prostatectomy from minimally invasive surgeries is the longest hospital stay. However, the question of what length of stay after this operation is optimal and necessary is unresolved. In this trial the investigators have compared a randomized group of patients that had discharged on postoperative day 2, 1 and same day surgery. The investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy (patient discharge in the same day of surgery - average 12 hours of hospitalization) while maintaining patient satisfaction and safety.
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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-
São Paulo
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Barretos、São Paulo、ブラジル、14784400
- Barretos' Cancer Hospital
-
-
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
説明
Inclusion Criteria:
- clinically localized Prostate Cancer (PCa)
- underwent open radical retropubic prostatectomy at Barretos' Cancer Hospital by a single primary surgeon (EFF)
- patients which the procedure went without any complications
- body mass index ≤ 30 kg/m2
Exclusion Criteria:
- Important comorbidities
- history of bleeding diathesis
- taking blood thinners
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:階乗代入
- 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 |
|---|---|
|
アクティブコンパレータ:patient discharge on postoperative day 2
The patient was discharge on postoperative day 2 (as was done routinely)
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The patient was discharge on postoperative day 2 (as was done routinely)
|
|
実験的:patient discharge on postoperative day 1
The patient was discharge on postoperative day 1
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The patient was discharge on postoperative day 1
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実験的:patient discharge in the day of surgery
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
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The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
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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 |
|---|---|---|
|
Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
時間枠:2 weeks postoperatively
|
The endpoint regarding the survey is the comparison with standard group discharged at postoperative day 2. The satisfaction was considered non similar when there were more than 1 negative answer for any question or any patient in comparison to standard group in these questions: Do you consider your postoperative care adequate ?
/ Was your understanding of the necessary postoperative care adequate before enrolling for this study?
Was your pain control adequate?
/ Was the length of hospitalization adequate?
/ Would you choose to have the procedure again with the same length of hospitalization?
/ Did you take any analgesic postoperatively after being discharged?
/ Did you take any analgesic postoperatively after being discharged?
/ Have you received adequate medical and nurse's care during the post-operative period?
/ Did you consider the access to the hospital easy if you needed it?
/ Would you recommend other men undergo this procedure the same way you?
|
2 weeks postoperatively
|
協力者と研究者
捜査官
- 主任研究者:Igor RM Franklin, MD、Barretos' Cancer Hospital
- スタディチェア:Eliney F Faria, PhD、Barretos' Cancer Hospital
- スタディディレクター:Wesley J Magnabosco, MD、Barretos' Cancer Hospital
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 (見積もり)
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
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