Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Cancer, Bladder Clinical Trial

Official title:

Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05822518
• Other study ID #: Nutrition in R.cystectomy
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer, Bladder
• Cystostomy; Complications
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• Neo-mune powder (otsuka pharmaceutical)
Preoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 3 days. Postoperative: Neo-mune (otsuka pharmaceutical) powder 60 gm o.d. orally (contains glutamine, arginine and fish oil) for 2 weeks starting when the intestinal sounds are audible.

Drug:
• Dipeptiven solution (Fresenius Kabi pharmaceutical)
Dipeptiven (Fresenius Kabi pharmaceutical) solution 50 mg o.d IV ( contains L-ananyl-L-glutamine dipeptide) post operatively for 5 days starting from the operation day.

Locations

Country	Name	City	State
Egypt	Menoufia Faculty of Medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	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.	30 days
Primary	Wound healing	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.	30 days
Primary	infectious complications	infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).	30 days
Secondary	Length of hospital stay	will be measured by number of days of hospital stay.	30 days
Secondary	Length of ICU stay	will be measured by number of days of ICU stay.	30 days