Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

March 23, 2024 updated by: Ammar Fathi Mohamed AlOrabi, Menoufia University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menoufia
      • Shibin Al Kawm, Menoufia, Egypt, 13829
        • Menoufia Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration 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 5 days starting from the operation day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
infectious complications
Time Frame: 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).
30 days
Postoperative complications
Time Frame: 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.
30 days
Wound healing
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 30 days
will be measured by number of days of hospital stay.
30 days
Length of ICU stay
Time Frame: 30 days
will be measured by number of days of ICU stay.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

April 1, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nutrition in R.cystectomy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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