Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Menoufia University42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cancer, Bladder Cystostomy; Complications

Interventions

Neo-mune powder (otsuka pharmaceutical)DIETARY_SUPPLEMENT

* 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.

Dipeptiven solution (Fresenius Kabi pharmaceutical)DRUG

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 30 days

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.

Time frame: 30 days

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).

Time frame: 30 days

Secondary Outcomes

Length of hospital stay

will be measured by number of days of hospital stay.

Time frame: 30 days

Length of ICU stay

will be measured by number of days of ICU stay.

Time frame: 30 days

Data from ClinicalTrials.gov

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