Clinical trial NCT01489800: The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
Official title: The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Complications
Keywords: feeding
complications
radical cystectomy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Complications after radical cystectomy for bladder cancer range from 30-40%, many of which are related to bowel function. Patients usually wait to eat until return of bowel function, although there is evidence that after primary intestinal or colonic surgery, patients may take food ad lib immediately, and that this is is associated with lower complication rate and shorter length of stay. The investigators hypothesize that early access to oral enteral nutrition (food at will) after cystectomy and urinary diversion will reduce the complication rate both in-hospital and within 90 days after hospital discharge.

Detailed description: Subjects preparing to undergo radical cystectomy and urinary diversion for bladder cancer that provide informed consent will be randomized into 1 of 2 study arms. The experimental arm will be offered clear liquid diet 24 hours after extubation and advanced to regular diet 24 hours later if clear liquids are well tolerated. The standard/control arm will receive a clear liquid diet at the time of return of bowel function, determined by significant flatus or bowel movements.

Information related to time to return of bowel function, frequency of nausea/vomiting, hospital complications and length of stay will be recorded. Patients will be followed with phone calls and chart reviews at 30, 60 and 90 days following surgery. Additional hospital admissions and/or complications will be determined with those phone calls.

Eligibility criteria: Inclusion Criteria:

* Age \>=18
* Bladder cancer
* Elect radical cystectomy and urinary diversion as treatment
* Able to provide informed consent

Exclusion Criteria:

* Radical cystectomy for reason other than bladder cancer

Primary outcomes:
measure: Complication rate
timeFrame: 90 day
Secondary outcomes:
measure: Primary Hospital Length of Stay
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Hospital - Cornell
state: New York
city: New York
country: United States
facility: Columbia Univeristy Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Mitchell C. Benson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SS, Cookson MS, Baumgartner RG, Wells N, Smith JA Jr. Analysis of early complications after radical cystectomy: results of a collaborative care pathway. J Urol. 2002 May;167(5):2012-6.
citation: Lassen K, Kjaeve J, Fetveit T, Trano G, Sigurdsson HK, Horn A, Revhaug A. Allowing normal food at will after major upper gastrointestinal surgery does not increase morbidity: a randomized multicenter trial. Ann Surg. 2008 May;247(5):721-9. doi: 10.1097/SLA.0b013e31815cca68.
citation: Pruthi RS, Nielsen M, Smith A, Nix J, Schultz H, Wallen EM. Fast track program in patients undergoing radical cystectomy: results in 362 consecutive patients. J Am Coll Surg. 2010 Jan;210(1):93-9. doi: 10.1016/j.jamcollsurg.2009.09.026. Epub 2009 Oct 28.
citation: Deibert CM, Silva MV, RoyChoudhury A, McKiernan JM, Scherr DS, Seres D, Benson MC. A Prospective Randomized Trial of the Effects of Early Enteral Feeding After Radical Cystectomy. Urology. 2016 Oct;96:69-73. doi: 10.1016/j.urology.2016.06.045. Epub 2016 Jul 8.