The Impact of Early Feeding After Radical Cystectomy for Bladder Cancer

NCT ID: NCT01489800

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-01-31

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.

Conditions

Bladder Cancer; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early Feeding

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.

Group Type: EXPERIMENTAL

Clear liquid diet

Intervention Type: BEHAVIORAL

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

Control Feeding

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

liquid diet

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell C. Benson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Hospital - Cornell

New York, New York, United States

Columbia Univeristy Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11956429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18438106 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20123338 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27402372 (View on PubMed)

Other Identifiers

AAAI0046

Identifier Type: -

Identifier Source: org_study_id