NCT01489800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

3.2 years

First QC Date

December 8, 2011

Last Update Submit

August 13, 2021

Conditions

Bladder CancerComplications

Keywords

feedingcomplicationsradical cystectomy

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    powered to detect 50% reduction in complication rate, from 40% down to 20%

    90 day

Secondary Outcomes (1)

  • Primary Hospital Length of Stay

    30 days

Study Arms (2)

Early Feeding

EXPERIMENTAL

Introduction of clear liquid diet 24 hours after extubation with advancement to regular diet 24 hours thereafter if there is no significant nausea or vomiting.

Behavioral: Clear liquid diet

Control Feeding

NO INTERVENTION

Standard of care with introduction of clear liquid diet at time of return of bowel function as determined by flatus. Advancement to full diet 24 later if clear diet well tolerated.

Interventions

Clear liquid dietBEHAVIORAL

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

Also known as: liquid diet
Early Feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Radical cystectomy for reason other than bladder cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New York Hospital - Cornell

New York, New York, 10021, United States

Location

Columbia Univeristy Medical Center

New York, New York, 10032, United States

Location

Related 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.

    PMID: 11956429BACKGROUND

  • 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.

    PMID: 18438106BACKGROUND

  • 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.

    PMID: 20123338BACKGROUND

  • 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.

    PMID: 27402372RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Mitchell C. Benson, M.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 12, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 17, 2021

Record last verified: 2021-08

Locations

US(2)