Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Study Overview
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Brief Summary
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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.

Official Title
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Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Conditions
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Cancer, Bladder, Cystostomy; Complications

Intervention / Treatment
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* Dietary Supplement: Neo-mune powder (otsuka pharmaceutical)
* Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Coagulopathy. Distant metastasis. Body mass index less than 18.5. Relevant food allergies. Severe renal and hepatic insufficiency.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional protocol group<br>patients who are enrolled in conventional pre and post operative routine preparation for surgery protocol. | |
| Active Comparator: immune enhancing nutrition protocol group<br>patients who are enrolled in immune enhancing nutrition protocol pre and post operatively. | Dietary Supplement: Neo-mune powder (otsuka pharmaceutical)<br>* 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.<br>Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | 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 | 
| Wound healing | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | will be measured by number of days to return to daily activity. | 30 days | 
| Infection rates | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complications, immune-nutrition, immune enhancing nutrition, bladder cancer, muscle invasive bladder cancer, radical cystectomy