Evaluation of Naloxegol in the Prevention of POI After Cystectomy

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Naloxegol

Criteria

Inclusion Criteria:

• Patients aged ≥ 18 years

• Informed consent signed

• Histopathological confirmation of bladder cancer

• Patients undergoing radical cystectomy and urinary diversion for an oncological indication

• Patients able to understand the study procedures, agreed to participate in the study program

• Patients affiliated to the national "Social Security" regimen or beneficiary of this regimen

Exclusion Criteria:

• Unwilling to undergo cystectomy

• Cystectomy for non-oncological indication

• Patients with concomitant upper urinary tract disease

• Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy

• Previous pelvic radiotherapy for prostate or bladder cancer

• Patients having taken opioids for more than seven days before surgery (to prevent peripheral withdrawal effects)

• Patients treated with drugs metabolized by certain enzymes (CYP3A4 and P-gp)

• Patients with severe hepatic impairment

• Patients with end-stage renal disease

• Patients with heart failure

• Patients with severe dementia that impacts daily functioning

• Pregnant and lactating females

• Not postmenopausal females and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm)

• Patients participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study

• Patients deprived of liberty or placed under the authority of a tutor or curator