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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear liquid diet | Behavioral | clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | powered to detect 50% reduction in complication rate, from 40% down to 20% | 90 day |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Hospital Length of Stay | time from admission for surgery until discharge after surgery | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell C. Benson, M.D. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Hospital - Cornell | New York | New York | 10021 | United States | ||
| Columbia Univeristy Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11956429 | Background | 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. | |
| 18438106 | Background | 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. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| New York |
| New York |
| 10032 |
| United States |
| 20123338 | Background | 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. |
| 27402372 | Result | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |