A Study of Surgical Techniques During Cystectomy
ConditionBladder Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No exclusion criteria
Patients on chronic opioid therapy are ineligible to receive alvimopan and will be excluded from this cohort of the trial
Trial design
Design model
Factorial
Treatments tested in this trial
Stent placement
Procedure/SurgerySurgeon 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.
Alvimopan
DrugPatient 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).
Treatment groups
530 Participants
are divided into 2 treatment groupsGroup A: Stent vs No StentExperimental treatment 1 intervention
Group B: Alvimopan vs No AlvimopanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Length of hospital stay (Alvimopan)
it will define success for the intervention as a length of stay \<6 days (6 days is the current median length of stay).
Time frame
greater than 6 days2
Symptomatic urinary tract infections (Stents)
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).
Time frame
within 30 days of surgerySponsors and contacts
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Source ClinicalTrials.gov