방광절제술 중 수술 기법에 관한 연구
근치 방광 절제술 및 수술 후 관리에 대한 수정에 대한 임상적으로 통합된 무작위 임상 시험(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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Bernard Bochner, MD
- 전화번호: 646-422-4387
연구 연락처 백업
- 이름: Alvin Goh, MD
- 전화번호: 646-422-4667
- 이메일: goha@mskcc.org
연구 장소
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New Jersey
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Basking Ridge, New Jersey, 미국, 07920
- 모병
- Memorial Sloan Kettering at Basking Ridge (Consent Only)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
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Middletown, New Jersey, 미국, 07748
- 모병
- Memorial Sloan Kettering Monmouth (Consent Only)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
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Montvale, New Jersey, 미국, 07645
- 모병
- Memorial Sloan Kettering Bergen (Consent Only)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
-
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New York
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Commack, New York, 미국, 11725
- 모병
- Memorial Sloan Kettering Suffolk-Commack (Consent Only)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
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Harrison, New York, 미국, 10604
- 모병
- Memorial Sloan Kettering Westchester (Consent Only)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
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Rockville Centre, New York, 미국, 11553
- 모병
- Memorial Sloan Kettering Nassau (Consent Only)
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연락하다:
- Alvin Goh, MD
- 전화번호: 646-422-4667
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
실험적: 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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of hospital stay (Alvimopan)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alvin Goh, MD, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24-361
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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