Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy

NCT05001763 | Unknown Phase 2

• 1 other identifier: IUNU-UC-101
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The first purpose is to determine whether prucalopride can promote the recovery of intestinal function after robot-assisted laparoscopic radical cystectomy and urinary diversion. The secondary objectives is to speed up postoperative ventilation, defecation, reduce the time of first solid food tolerance, reduce postoperative hospital stay, reduce the incidence of readmission due to intestinal obstruction and the incidence of complications within 180 days.

Conditions

Postoperative Ileus; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Time to defaecation, measured in hours, from the time the surgery ends till the first observed

  up to 30 days after surgery

Secondary Outcomes (7)

• Postoperative first passing flatus reported by the patients

  up to 30 days after surgery

• First solid food tolerance time

  up to 30 days after surgery

• Postoperative C-reactive protein(CRP)

  postoperative day 1 and 3

• Length of postoperative hospital stay (LOS)(days)

  30 days or until hospital discharge whichever occurs first

• Incidence of readmission within 180 days

  up to 180 days after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Glucose, 2mg, tablet.

Drug: Placebo

Prucalopride

EXPERIMENTAL

Prucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment.

Drug: Prucalopride

Interventions

Prucalopride DRUG

Prucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment

Also known as: Resolor

Prucalopride

Placebo DRUG

Glucose, 2mg, tablet.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are prepared to undergo robot-assisted laparoscopic radical cystectomy + urinary diversion due to bladder tumor;
• urinary diversion: ileal cystectomy or orthotopic neobladder;
• age ≥ 18 years old and ≤ 80 years old;
• ECOG score ≤ 1;
• important laboratory indicators meet:
• Blood routine test: neutrophil count ≥ 1.5 × 109 g / L, leukocyte count ≥ 4.0 × 109 × 10 \~ 9/L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 9 g /dl
• Electrolytes: 135mmol/L ≤ serum sodium ≤ 145mmol/L , 2.25mmol/L ≤ serum calcium ≤ 2.75mmol/l, 3.5mmolexL ≤ serum potassium ≤ 5.5mmo/L; Liver function index: glutamic pyruvic transaminase (ALT) and aspartate oxaloacetic transaminase (AST) ≤ 2.5 times the upper limit of normal value (ULN), total bilirubin TBIL ≤ 1.5 × ULN;
• d. Renal function: serum creatinine ≤ 21. 5 × ULN, eGFR ≥ 30 mL / min; e. Coagulation function: international standardized ratio (INR) \< 1.5. f. The left ventricular ejection fraction ((LVEF)) was 50%;
• The drugs that affected the observation of this experiment were not used one week before the selection. Atropine drugs; P-glycoprotein inhibitors: ketoconazole, verapamil, cyclosporine A, quinidine; erythromycin;
• Have good defecation habits, which is defecating more than 3 times a week;
• Have no previous intestinal surgery and no history of other tumors.
• The subjects voluntarily participated, and the subjects themselves must sign an informed consent form (ICF), to show that they understand the purpose and procedures of this study, and are willing to participate in the study. Subjects must be willing and comply with the prohibitions and restrictions set out in the study program.

You may not qualify if:

• Patients who cannot tolerate radical cystectomy,
• patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).
• uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.
• Patients with the allergy or hypersensitivity of prucalopride;
• Patients with active or symptomatic viral hepatitis or other chronic liver diseases, known to be infected with human immunodeficiency virus (HIV);
• Active pulmonary tuberculosis;
• Patients with severe heart, liver and kidney diseases;
• Patients with a history of constipation, which is defined as defecation less than 3 times a week, and strenuous defecation.
• Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease);
• Patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption shall not take prucalopride.
• Previous operations involving intestinal, history of other tumors, history of intestinal obstruction;
• Lack of legal capacity or limitation of legal capacity;
• Other situations in which researchers considered it inappropriate to participate in this study.
• Elimination standard
• Those who were treated with other local or systemic that interfere this study at the same time;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

prucalopride

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hongqian Guo, MD

CONTACT

13605171690; dr.ghq@nju.edu.cn

Shiwei Zhang, MD

CONTACT

13813916981; zsw999@hotmall.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 12, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 12, 2021

Record last verified: 2021-08