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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8N4A6
- St. Joseph's Healthcare Hamilton - McMaster Institute of Urology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Laparoscopic Assisted Partial Nephrectomy
Current standard for partial nephrectomies.
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Robotic (Davinci)
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활성 비교기: Robotic Assisted Partial Nephrectomy
Possible new standard for partial nephrectomies.
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Regular Laparoscopic Technique.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Warm ischemia time
기간: Duration of the Surgical Procedure (Nephrectomy)
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It will be measured intraoperatively from the time of application of Satinsky clamp on the renal hilum to the release of clamp (in minutes).
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Duration of the Surgical Procedure (Nephrectomy)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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eGFR
기간: Up to 24 months post operatively.
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It will be measured preoperatively, postoperatively and at each of the follow-up visit.
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Up to 24 months post operatively.
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Estimated blood loss
기간: Duration of the Surgical Procedure (Nephrectomy)
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Will be measured intraoperatively from the amount of blood (ml) in the suction container.
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Duration of the Surgical Procedure (Nephrectomy)
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Complication rates as per Clavien-Dindo classification
기간: Up to 24 months post-operatively.
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It will be recorded for the intra-operative, post-operative and follow-up period.
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Up to 24 months post-operatively.
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Conversion rate to radical nephrectomy or OPN due to technical difficulty.
기간: 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
기간: 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.
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|
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Length of hospital stay
기간: 3-7 Days
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Calculated from day of admission to day of discharge from hospital.
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3-7 Days
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Positive surgical margin rate
기간: 14 days
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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
기간: 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.
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Up to 1 year
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RALPLPNNX
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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