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Completed

NCT Number: NCT05822518

Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

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.

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Key information

Conditions

Cancer, Bladder Cystostomy; Complications Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, 13829, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

Secondary outcomes

  1. Length of hospital stay

    Time frame: 30 days

    will be measured by number of days of hospital stay.

  2. Length of ICU stay

    Time frame: 30 days

    will be measured by number of days of ICU stay.

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 20, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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