NCT05822518

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

April 1, 2023

Last Update Submit

March 23, 2024

Conditions

Cancer, BladderCystostomy; Complications

Keywords

radical cystectomycomplicationsimmune-nutritionimmune enhancing nutritionbladder cancermuscle invasive bladder cancer

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    30 days

Secondary Outcomes (2)

  • Length of hospital stay

    30 days

  • Length of ICU stay

    30 days

Study Arms (2)

conventional protocol group

NO INTERVENTION

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

immune enhancing nutrition protocol group

ACTIVE COMPARATOR

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)Drug: Dipeptiven solution (Fresenius Kabi pharmaceutical)

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.

immune enhancing nutrition protocol group
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.

immune enhancing nutrition protocol group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Coagulopathy.
  • Distant metastasis.
  • Body mass index less than 18.5.
  • Relevant food allergies.
  • Severe renal and hepatic insufficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, 13829, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ammar Fathi Mohamed AlOrabi

Study Record Dates

First Submitted

April 1, 2023

First Posted

April 20, 2023

Study Start

June 1, 2022

Primary Completion

November 30, 2023

Study Completion

February 1, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

EG(1)