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

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

1. patients who are prepared to undergo robot-assisted laparoscopic radical cystectomy + urinary diversion due to bladder tumor;

2. urinary diversion: ileal cystectomy or orthotopic neobladder;

3. age ≥ 18 years old and ≤ 80 years old;

4. ECOG score ≤ 1;

5. important laboratory indicators meet:

1. 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

2. 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%;

6. 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;

7. Have good defecation habits, which is defecating more than 3 times a week;

8. Have no previous intestinal surgery and no history of other tumors.

9. 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.

Exclusion Criteria:

1. Patients who cannot tolerate radical cystectomy,

2. patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).

3. 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.

4. Patients with the allergy or hypersensitivity of prucalopride;

5. Patients with active or symptomatic viral hepatitis or other chronic liver diseases, known to be infected with human immunodeficiency virus (HIV);

6. Active pulmonary tuberculosis;

7. Patients with severe heart, liver and kidney diseases;

8. Patients with a history of constipation, which is defined as defecation less than 3 times a week, and strenuous defecation.

9. Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease);

10. Patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption shall not take prucalopride.

11. Previous operations involving intestinal, history of other tumors, history of intestinal obstruction;

12. Lack of legal capacity or limitation of legal capacity;

13. Other situations in which researchers considered it inappropriate to participate in this study.

Elimination standard

1. Those who were treated with other local or systemic that interfere this study at the same time;

2. Using other foods and drugs that interfere the tolerance judgment at the same time;

3. Violating the requirements of the study scheme, not according to the dose and course of treatment specified in the study plan;

4. Poor quality, incomplete and inaccurate of data recording;

5. Poor compliance;

6. Loss of follow-up.

Termination criteria

1. Subjects require discontinuation of research treatment;

2. Deterioration of disease;

3. Any clinical AE, laboratory examination abnormalities or concomitant diseases, according to the judgment of the researchers, continuing to participate in the study is not the greatest benefit to the subjects;

4. Serious adverse events.

5. The informed consent form can no longer be signed freely because of imprisonment or forced detention for the treatment of mental illness or somatic disease (such as infectious diseases);

6. Postoperative imagings indicate ileus;

7. At the end of treatment, the function of intestines still do not recover.