膀胱切除術中の手術手技の研究
根治的膀胱切除術と術後ケアの変更に関する臨床的に統合されたランダム化臨床試験 (RCT)
The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes:
A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection.
Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice.
The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Bernard Bochner, MD
- 電話番号：646-422-4387
研究連絡先のバックアップ
- 名前：Alvin Goh, MD
- 電話番号：646-422-4667
- メール：goha@mskcc.org
研究場所
-
-
New Jersey
-
Basking Ridge、New Jersey、アメリカ、07920
- 募集
- Memorial Sloan Kettering at Basking Ridge (Consent Only)
-
コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
Middletown、New Jersey、アメリカ、07748
- 募集
- Memorial Sloan Kettering Monmouth (Consent Only)
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コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
Montvale、New Jersey、アメリカ、07645
- 募集
- Memorial Sloan Kettering Bergen (Consent Only)
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コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
-
New York
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Commack、New York、アメリカ、11725
- 募集
- Memorial Sloan Kettering Suffolk-Commack (Consent Only)
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コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
Harrison、New York、アメリカ、10604
- 募集
- Memorial Sloan Kettering Westchester (Consent Only)
-
コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
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コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
Rockville Centre、New York、アメリカ、11553
- 募集
- Memorial Sloan Kettering Nassau (Consent Only)
-
コンタクト：
- Alvin Goh, MD
- 電話番号：646-422-4667
-
-
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:
Stent vs. no stent
- Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons Alvimopan vs. no alvimopan
- Patients aged ≥21 years who are scheduled to undergo radical cystectomy for treatment of bladder cancer with one of the consenting surgeons
Exclusion Criteria:
Stent vs. no stent
- No exclusion criteria
Alvimopan vs. no alvimopan
- Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial
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 |
|---|---|
|
実験的：Stent vs No Stent
For patients treated by a surgeon randomized to use ureteral stents, the operating surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice to be placed across the ureteroenteric anastomosis intraoperatively. Because there is no standard ureteral stent size or type, the surgeon will select a stent type and size according to their experience and will document the stent size and type used. This is already routinely recorded as part of the standard of care at MSK. |
Surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice. |
|
実験的：Alvimopan vs No Alvimopan
For patients randomized to receive alvimopan, the patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses), as indicated on the medication's FDA label. This is the current standard of care for most cases at MSK. |
Patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses). |
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 |
|---|---|---|
|
Length of hospital stay (Alvimopan)
時間枠：greater than 6 days
|
it will define success for the intervention as a length of stay <6 days (6 days is the current median length of stay). |
greater than 6 days
|
|
Symptomatic urinary tract infections (Stents)
時間枠：within 30 days of surgery
|
defined as the presence of signs or symptoms indicative of infection (fever, flank or abdominal pain, leukocytosis, radiographic imaging consistent with pyelonephritis) and a positive urine culture (>100,000 CFU pathogenic bacteria on an appropriately collected urine specimen). |
within 30 days of surgery
|
協力者と研究者
捜査官
- 主任研究者：Alvin Goh, MD、Memorial Sloan Kettering Cancer Center
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
追加の関連 MeSH 用語
その他の研究ID番号
- 24-361
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
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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
米国で製造され、米国から輸出された製品。
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。