En undersøgelse af kirurgiske teknikker under cystektomi
Et klinisk integreret randomiseret klinisk forsøg (RCT) af ændringer til radikal cystektomi og postoperativ pleje
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Bernard Bochner, MD
- Telefonnummer: 646-422-4387
Undersøgelse Kontakt Backup
- Navn: Alvin Goh, MD
- Telefonnummer: 646-422-4667
- E-mail: goha@mskcc.org
Studiesteder
-
-
New Jersey
-
Basking Ridge, New Jersey, Forenede Stater, 07920
- Rekruttering
- Memorial Sloan Kettering at Basking Ridge (Consent Only)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
Middletown, New Jersey, Forenede Stater, 07748
- Rekruttering
- Memorial Sloan Kettering Monmouth (Consent Only)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
Montvale, New Jersey, Forenede Stater, 07645
- Rekruttering
- Memorial Sloan Kettering Bergen (Consent Only)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
-
New York
-
Commack, New York, Forenede Stater, 11725
- Rekruttering
- Memorial Sloan Kettering Suffolk-Commack (Consent Only)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
Harrison, New York, Forenede Stater, 10604
- Rekruttering
- Memorial Sloan Kettering Westchester (Consent Only)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
Rockville Centre, New York, Forenede Stater, 11553
- Rekruttering
- Memorial Sloan Kettering Nassau (Consent Only)
-
Kontakt:
- Alvin Goh, MD
- Telefonnummer: 646-422-4667
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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). |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of hospital stay (Alvimopan)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Alvin Goh, MD, Memorial Sloan Kettering Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24-361
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
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