Cancer, Bladder, Cystostomy; Complications
Conditions
Keywords
radical cystectomy, complications, immune-nutrition, immune enhancing nutrition, bladder cancer, muscle invasive bladder cancer
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.
Interventions
DIETARY_SUPPLEMENTNeo-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.
DRUGDipeptiven 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.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of ICU stay | 30 days | will be measured by number of days of ICU stay. |
| Length of hospital stay | 30 days | will be measured by number of days of hospital stay. |
Countries
Egypt
Outcome results
None listed