Perioperative medicine & outcomes
Immune-Enhancing Nutrition and Outcomes After Radical Cystectomy: A Randomized Clinical Trial
Primary result · Any 30-day complicationResult — go to the resultOdds ratio 1.18 95% CI 0.64–2.18Authors' conclusion
In this randomized clinical trial of adults undergoing radical cystectomy, perioperative specialized immunonutrition did not reduce 30-day complications compared with standard oral nutrition.
Study context
- Population
- Adults with bladder cancer scheduled for radical cystectomy, able to swallow oral liquids, without severe malnutrition178 evaluable
- Participants
- 203 adults
- Comparison
- Immunonutrition vs Standard
- Immunonutritionn = 99
- Standardn = 104reference
- Primary endpoint
- Any complication (Clavien-Dindo grade ≥1)
- Follow-up
- 30 days
Methodological detailsmulticentre, double-blind, phase 3, 13 US academic and community sites; enrolment March 5, 2019, through October 19, 2023, Adherence 94.5% (52 of 55) by plasma arachidonic acid to eicosapentaenoic acid biomarker
- Multicentre
- Double-blind
- Phase 3
- 13 US academic and community sites; enrolment March 5, 2019, through October 19, 2023
- Adherence 94.5% (52 of 55) by plasma arachidonic acid to eicosapentaenoic acid biomarker
Primary result
Any 30-day complication
Odds ratio
1.18
95% CI 0.64–2.18
Events by treatment group
Immunonutrition vs Standard
OR 1.18 (95% CI 0.64–2.18)
As reported in the abstract
Secondary outcomes
| Outcome | Immunonutrition | Standard | OR (95% CI) | |
|---|---|---|---|---|
| High-grade complications · 30 days | 11.1% | 12.5% | 0.86 (0.34–2.17) | |
| 0.20.5125Odds ratio (log scale) |
Overall survival · 2 years · not statistically significant
Disease-free survival · 2 years
Safety
Adverse events (nausea most common)
- Adverse events (nausea most common): immunonutrition denominator 91
Original publication
Immune-Enhancing Nutrition and Outcomes After Radical Cystectomy: A Randomized Clinical Trial. JAMA Netw Open. Published 1 July 2026. doi:10.
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