A Phase 2 interventional study of Naloxégol oxalate and Placebo oral tablet in Bladder Cancer and Cystostomy; Complications, sponsored by Institut Paoli-Calmettes. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by Institut Paoli-Calmettes · Phase 2, Interventional, and Treatment
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.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Institut Paoli-Calmettes is the lead sponsor of 168 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
ERAS program with administration of experimental treatment: Naloxegol 25mg administrated once daily from surgery for up to 7 days
Drug: Naloxégol oxalate
ERAS program with administration of placebo: Placebo administrated once daily from surgery for up to 7 days
Drug: Placebo oral tablet
Oral administration once daily
Also known as: Naloxegol
Oral administration once daily
Also known as: Placebo
Time of hospital discharge
Comparaison between treatment group and placebo group for post-operative length of stay between the date of hospital discharge and the date of surgery
Time frame: Date at which treatment is initiated and date of hospital discharge (up to 12 days)
Rate of reinsertion of nasogastric tube
Comparaison between treatment group and placebo group for rate of reinsertion of nasogastric tube
Time frame: From post-surgery to hospital discharge (up to 12 days)
Time to reach gastrointestinal recovery
Comparaison between treatment group and placebo group for time ot reach gastrointestinal recovery
Time frame: Date at which the patient has the first gaz from post-surgery (up to 12 days)
Rate of 30-day postoperative complications
Comparaison between treatment group and placebo group for rate of 30-day postoperative complications with Clavien-Dindo classification grade I-V
Time frame: Postoperative complications from surgery, to 30-day postsurgery and to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)
Rate of major postoperative complications of 90-day postoperative period
Comparaison between treatment group and placebo group for rate of major postoperative complications with Clavien-Dindo classification grade III-IV-V
Time frame: Major postoperative complications from surgery to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)
No study locations are listed for this record.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Institut Paoli-Calmettes