A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses (RALPLPNNX)
A Prospective Randomized Controlled Trial Comparing Two Minimally Invasive Surgical Modalities - Robotic Assisted Vs. Pure Laparoscopic Partial Nephrectomy For Small Renal Masses.
調査の概要
状態
詳細な説明
Small renal masses (SRM) <4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.
The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Ontario
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Hamilton、Ontario、カナダ、L8N4A6
- St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
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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
説明
Inclusion Criteria:
- Patients at least 18 years of age and capable of giving informed consent
- Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
- Patients with SRMs (tumor(s) ≤ 4 cm)
Exclusion Criteria:
- Large tumors > 4.0cm
- Unable to have a general anesthetic
- Unable to comply with post-operative follow-up protocol
- Uncorrectable bleeding diathesis
- Tumors unsuitable for LPN/RALPN technique
- Evidence of metastatic disease
- Prior surgery on the affected kidney
- Ectopic or malrotated kidney
- Mental health condition that precludes 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
- 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：独身
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：Laparoscopic Assisted Partial Nephrectomy
Current standard for partial nephrectomies.
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Robotic (Davinci)
|
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アクティブコンパレータ：Robotic Assisted Partial Nephrectomy
Possible new standard for partial nephrectomies.
|
Regular Laparoscopic Technique.
|
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 |
|---|---|---|
|
Warm ischemia time
時間枠：Duration of the Surgical Procedure (Nephrectomy)
|
It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
|
Duration of the Surgical Procedure (Nephrectomy)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
eGFR
時間枠：Up to 24 months post operatively.
|
It will be measured preoperatively, postoperatively and at each of the follow-up visit.
|
Up to 24 months post operatively.
|
|
Estimated blood loss
時間枠：Duration of the Surgical Procedure (Nephrectomy)
|
Will be measured intraoperatively from the amount of blood (ml) in the suction container.
|
Duration of the Surgical Procedure (Nephrectomy)
|
|
Complication rates as per Clavien-Dindo classification
時間枠：Up to 24 months post-operatively.
|
It will be recorded for the intra-operative, post-operative and follow-up period.
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Up to 24 months post-operatively.
|
|
Conversion rate to radical nephrectomy or OPN due to technical difficulty.
時間枠：Duration of the Surgical Procedure
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From the start of the partial nephrectomy in minutes to the time it was decided to convert to a radical nephrectomy.
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Duration of the Surgical Procedure
|
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Postoperative pain
時間枠：Minutes to hours after nephrectomy up to 3 months post-operatively.
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Minutes to hours after nephrectomy up to 3 months post-operatively.
|
|
|
Length of hospital stay
時間枠：3-7 Days
|
Calculated from day of admission to day of discharge from hospital.
|
3-7 Days
|
|
Positive surgical margin rate
時間枠：14 days
|
Will be based on the final pathology results which are usually ready in 1-2 weeks post surgery.
Distance to surgical margin will be looked at (mm to cm).
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14 days
|
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Costs of treatment
時間枠：Up to 1 year
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Clinical data and resource use for both treatments will be collected and unit cost estimates will be based on the St.
Joseph Healthcare case-costing system.
The cost will be conducted from the perspective of Ontario Ministry of Health and Long-term Care.
The cost of hospital stay will be calculated along with any hospital stay/procedure associated with a post-op complication.
|
Up to 1 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
その他の研究ID番号
- RALPLPNNX
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
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Robotic Assisted Nephrectomyの臨床試験
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University of Rome Tor Vergata完了