Radical cystectomy is the standard of care for muscle invasive bladder cancer, however despite advances, it is still associated with high morbidity. Many complications may be driven by dehydration and it is unclear if a home intravenous fluid (IVF) infusion program post-operatively, which is an accepted standard practice, is beneficial. This study is a single institution randomized controlled trial where patients who choose to undergo radical cystectomy for bladder cancer will be randomized to an Enhanced Recovery After Surgery (ERAS) protocol with a home IVF program, consisting of 1 liter (L) of crystalloid fluid three times per week for four weeks, or ERAS protocol alone. The primary outcome will be 90-day hospital re-admissions, with secondary outcomes including 30 and 90 day complications.
Adult patients greater than 18 years of age and older
Confirmed urothelial carcinoma on pathology, including muscle invasive, non-muscle invasive, and variant histology
Patient electing to undergo radical cystectomy with bilateral pelvic lymphadenectomy after counseling with a urologic oncologist.
Patients undergoing radical cystectomy for benign indications (e.g. chronic bladder pain, fistulas, severe lower urinary tract symptoms)
Patients undergoing radical cystectomy for a non-bladder primary malignancy (e.g. rectal, colon, uterine cancers).
Patients with extensive locally advanced disease necessitating a pelvic exenteration
Contraindication to receiving home IVF therapy (i.e. pre-existing cardiac, renal, hepatic dysfunction)
Parallel
Intravenous fluids
Other interventionAt home, the patient receives a 1L bolus of either lactated ringers or normal saline three times a week for four weeks with the patient's home nurse.
ERAS
Other interventionPatients assigned to not receive home IVF will receive everything in the investigator's current ERAS protocol except the home intravenous fluid program. Patients without preexisting vascular access will not receive a midline catheter post-operatively, however the participant will still receive home care for skilled nursing who will provide wound care, ostomy teaching, and education about perioperative fluid management.
Percentage of participants with 90-day Hospital Readmission
The primary outcome will be 90-day hospital readmissions that are unplanned, including admissions for observation
Percentage of participants with 30-day hospital readmissions
The percentage of patients with unplanned hospital readmission within 30 days post-discharge after surgery
Percentage of participants with 90-day emergency department presentations
The percentage of patients with presentations to the emergency department within 90 days after surgery
Percentage of participants with All-cause Complications
All-cause complications including complications related to the surgery like bleeding, infection, Acute Kidney Injury (AKI), failure to thrive, and complications related to midline or port venous access including infection and thrombosis.
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