Clinical trial · Interventional
Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
A Pilot Study of Perioperative Oral Nutrition Supplementation to Improve Nutritional Status, Post-operative Complications, Length of Stay and Readmission Rates in Patients Undergoing Radical Cystectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition. The investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not. Patients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensure Plus® | Dietary Supplement | — | UNRESOLVED |
| Multivitamin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nutrition Intervention
- description
- Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery
- interventionNames
- Dietary Supplement: Ensure Plus®
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery
- interventionNames
- Dietary Supplement: Multivitamin
Primary outcomes (1)
- measure
- Hospital-free days (HFDs)
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution Exclusion Criteria: * inability to tolerate oral supplementation
References
Publications (3)
- BACKGROUNDGregg JR, Cookson MS, Phillips S, Salem S, Chang SS, Clark PE, Davis R, Stimson CJ Jr, Aghazadeh M, Smith JA Jr, Barocas DA. Effect of preoperative nutritional deficiency on mortality after radical cystectomy for bladder cancer. J Urol. 2011 Jan;185(1):90-6. doi: 10.1016/j.juro.2010.09.021. Epub 2010 Nov 12. PMID 21074802
- BACKGROUNDStimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17. PMID 20723939
- BACKGROUNDMorgan TM, Keegan KA, Barocas DA, Ruhotina N, Phillips SE, Chang SS, Penson DF, Clark PE, Smith JA Jr, Cookson MS. Predicting the probability of 90-day survival of elderly patients with bladder cancer treated with radical cystectomy. J Urol. 2011 Sep;186(3):829-34. doi: 10.1016/j.juro.2011.04.089. Epub 2011 Jul 23. PMID 21788035