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The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

Primary Purpose

Bladder Cancer, Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clear liquid diet
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bladder Cancer focused on measuring feeding, complications, radical cystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Hospital - Cornell
  • Columbia Univeristy Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Feeding

Control Feeding

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Primary Hospital Length of Stay
time from admission for surgery until discharge after surgery

Full Information

First Posted
December 8, 2011
Last Updated
August 13, 2021
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01489800
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Complications
Keywords
feeding, complications, radical cystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Feeding
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Feeding
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Clear liquid diet
Other Intervention Name(s)
liquid diet
Intervention Description
clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.
Primary Outcome Measure Information:
Title
Complication rate
Description
powered to detect 50% reduction in complication rate, from 40% down to 20%
Time Frame
90 day
Secondary Outcome Measure Information:
Title
Primary Hospital Length of Stay
Description
time from admission for surgery until discharge after surgery
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell C. Benson, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Hospital - Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Univeristy Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11956429
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.
Results Reference
background
PubMed Identifier
18438106
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.
Results Reference
background
PubMed Identifier
20123338
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.
Results Reference
background
PubMed Identifier
27402372
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.
Results Reference
result

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The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

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