Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05822518

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Bladder Cystostomy; Complications	Dietary Supplement: Neo-mune powder (otsuka pharmaceutical) Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: conventional protocol group patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol.
Active Comparator: immune enhancing nutrition protocol group patients who are enrolled in immune enhancing nutrition protocol pre and post operatively.	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 2 weeks starting from the operation day.

Arm

Intervention/Treatment

No Intervention: conventional protocol group

patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol.

Active Comparator: immune enhancing nutrition protocol group

patients who are enrolled in immune enhancing nutrition protocol pre and post operatively.

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 2 weeks starting from the operation day.

Outcome Measures

Primary Outcome Measures

Postoperative complications [30 days]
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.
Wound healing [30 days]
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.

Secondary Outcome Measures

Recoverability time [30 days]
will be measured by number of days to return to daily activity.
Infection rates [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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