Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Not Applicable

Completed

• Conditions: Cancer, Bladder; Cystostomy; Complications
• Interventions: Dietary Supplement: Neo-mune powder (otsuka pharmaceutical); Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)

• Registration Number: NCT05822518
• Lead Sponsor: Menoufia University

Brief Summary

The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2023-04-01
• Study First Submitted QC: 2023-04-19
• Study First Posted: 2023-04-20
• Primary Completion: 2023-11-30
• Study Completion: 2024-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-23
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Patients with CT showing bladder mass with radiological staging of T2 or T3.
2. Patients pathologically proven to have cancer bladder.
3. Patients undergoing radical cystectomy with ileal conduit.
4. The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.

Exclusion Criteria

1. Coagulopathy.
2. Distant metastasis.
3. Body mass index less than 18.5.
4. Relevant food allergies.
5. Severe renal and hepatic insufficiency.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immune enhancing nutrition protocol group	Dipeptiven solution (Fresenius Kabi pharmaceutical)	patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively.
immune enhancing nutrition protocol group	Neo-mune powder (otsuka pharmaceutical)	patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively.

Primary Outcome Measures

Name	Time	Method
Wound healing	30 days	The number of properly healed wounds. wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.
infectious complications	30 days	infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).
Postoperative complications	30 days	The number of postoperative complications, either infectious or non-infectious. Postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	30 days	will be measured by number of days of hospital stay.
Length of ICU stay	30 days	will be measured by number of days of ICU stay.

Trial Locations

Locations (1)

Menoufia Faculty of Medicine; 🇪🇬 Shibin Al Kawm, Menoufia, Egypt