Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Amino Acids

Arginine

Glutamine

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

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

* 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.

Neo-mune powder (otsuka 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.

Dipeptiven solution (Fresenius Kabi pharmaceutical)

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.

Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy

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.

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.

infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).

will be measured by number of days of hospital stay.

will be measured by number of days of ICU stay.

Menoufia University

Ammar Fathi Mohamed AlOrabi

Digestive System Diseases

Ileus

Analgesics

Central Nervous System Depressants

Narcotic Antagonists

Analgesics, Opioid

Naloxegol

Narcotics

ERAS program with administration of experimental treatment: Naloxegol 25mg administrated once daily from surgery for up to 7 days

ERAS program with administration of placebo: Placebo administrated once daily from surgery for up to 7 days

Naloxégol oxalate

Placebo oral tablet

Dominique GENRE, MD

Carine Cormary-Feuillet, PhD

Géraldine Pignot, MD, PhD

Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after radical cystectomy. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs.

In order to optimize perioperative care for patients undergoing radical cystectomy in a context of an ERAS (Enhanced Recovery After Surgery) program, we will evaluate the effectiveness of systemic pharmacologic opioid antagonist treatment.

Radical cystectomy (RC) with urinary diversion represents the gold standard treatment for muscle-invasive bladder cancer. Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after RC. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs.

Faster gastrointestinal recovery and prevention of POI are at the heart of ERAS (Enhanced Recovery After Surgery) protocols. In order to optimize the post-operative consequences of patients operated on for a cystectomy within the framework of a RAAC program, several provisions aim to alleviate post-operative gastrointestinal dysfunctions.

Naloxegol, peripherally acting µ-opioid receptor antagonist, is currently approved for opioid-induced constipation in Chronic Non-Cancer Pain, but its potential interest to prevent POI has never been assessed. In this randomized, double-blind, placebo-controlled trial, the administration of Naloxegol for a limited duration as part of ERAS (Enhanced Recovery After Surgery) program will be evaluated to reduce the time of hospital discharge (length of stay) and to reduce the rate of postoperative complications. Priamry and secondary objectives will be compared between naloxegol and placebo groups.

Randomized, Double-blind, placebo-controlled

Evaluation of Naloxegol in the Prevention of POI After Cystectomy

Evaluation of Naloxegol, a Peripherally Acting µ-opioid Receptor Antagonist, in the Prevention of Postoperative Ileus After Cystectomy

Comparaison between treatment group and placebo group for post-operative length of stay between the date of hospital discharge and the date of surgery

Comparaison between treatment group and placebo group for rate of reinsertion of nasogastric tube

Comparaison between treatment group and placebo group for time ot reach gastrointestinal recovery

Comparaison between treatment group and placebo group for rate of 30-day postoperative complications with Clavien-Dindo classification grade I-V

Comparaison between treatment group and placebo group for rate of major postoperative complications with Clavien-Dindo classification grade III-IV-V

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy	NCT05822518	Cancer, Bladder Cystostomy; Com...	Neo-mune powder... Dipeptiven solu...	-	Menoufia University
Evaluation of Naloxegol in the Prevention of POI After Cystectomy	NCT04219046	Bladder Cancer Cystostomy; Com...	Naloxégol oxala... Placebo oral ta...	18 Years -	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for cystostomy; complications