Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

Menoufia University

Status: Completed

Conditions: Cystostomy; Complications; Cancer, Bladder

Treatments: Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical); Dietary Supplement: Neo-mune powder (otsuka pharmaceutical)

Study type: Interventional

Funder types: Other

Identifiers

NCT05822518

Nutrition in R.cystectomy

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

conventional protocol group

No Intervention group

Description:

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

immune enhancing nutrition protocol group

Active Comparator group

Description:

patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively.

Treatment:

Dietary Supplement: Neo-mune powder (otsuka pharmaceutical)

Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)