The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489800
• Other study ID #: AAAI0046
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: August 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Complications
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Clear liquid diet
clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.

Locations

Country	Name	City	State
United States	Columbia Univeristy Medical Center	New York	New York
United States	New York Hospital - Cornell	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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 J — View Citation

Lassen K, Kjaeve J, Fetveit T, Tranø 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	powered to detect 50% reduction in complication rate, from 40% down to 20%	90 day
Secondary	Primary Hospital Length of Stay	time from admission for surgery until discharge after surgery	30 days