Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355518
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-19
Brief Title:
Pre-operative Immuno-Nutrition in Radical Cystectomy
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Pre-operative Immuno-nutrition in Patients Undergoing Radical Cystectomy for Bladder Cancer a Multicentre Randomised Open-label Parallel Group Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INu-RC
Brief Summary:
This study will evaluate the effect of preoperative oral immunonutrition on postoperative complications in patients undergoing radical cystectomy for bladder cancer Patients receiving preoperative immunonutrition will be compared to controls receiving a standard high-calorie high-protein oral nutritional supplement
Detailed Description:
Radical cystectomy with pelvic lymph node dissection and urinary reconstruction is a major surgical procedure performed for bladder cancer The literature reports an incidence of 50-88 and 30-42 for any grade complications Clavier-Dindo grade I-IV and severe complications Clavier-Dindo grade III respectively Nutritional status prior to radical cystectomy has been shown to be a strong predictor of 90-day mortality The term immunonutrition refers to the oral or enteral administration of specific substrates such as omega-3 fatty acids arginine and nucleotides These substrates have been shown to upregulate the host immune response modulate inflammatory responses and improve protein synthesis after surgery with a favorable impact on postoperative infection rates and length of hospital stay in major abdominal surgery Data on patients undergoing radical cystectomy are scarce mainly due to the small sample size of the studies However the available evidence suggests a potential beneficial effect of this nutritional intervention in patients undergoing radical cystectomy Several aspects remain largely unclear including the dosage and timing of immunonutrition and the impact of preoperative malnutrition risk on the efficacy of immunonutrition This study will evaluate the effect of 7 days of preoperative immunonutrition on postoperative complications compared to patients receiving standard high-calorie high-protein oral nutritional supplements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None