Postoperative Ileus Clinical Trial
Official title:
A Randomized, Controlled, Double-blind Efficacy and Tolerability Study Of Prucalopride For The Treatment Of Postoperative Ileus In Patients Undergoing Gastrointestinal Surgery
Verified date | September 2016 |
Source | Jinling Hospital, China |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the effect and safety of prucalopride on recovery of gastrointestinal function in patient undergoing major gastrointestinal surgery. The investigators hypothesize that patients who take prucalopride after major gastrointestinal surgery will have shorter duration of postoperative ileus.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Consecutive patients undergoing elective gastric, small bowel, or partial colonic resection via laparotomy or laparoscopy. 2. Patients with American Society of Anaesthesiologists grading I-III 3. Informed consent available. Exclusion Criteria: 1. Patients with stoma creation, extensive adhesiolysis, total or subtotal colectomy , or patients who had a history of total or subtotal colectomy. 2. Patients who developed intraoperative problems or complications, or had peritoneal carcinomatosis. 3. Patients who developed serious complications within 24 hours after surgery. 4. Those who received epidural anesthesia or analgesia. 5. Patients who received other prokinetic drugs. 6. Patients who were allergic to prucalopride. 7. Patients with severe comorbidity and/or organ(kidney, liver, and heart) dysfunction 8. Patients had complete bowel obstruction 9. Patients who have participated other clinical trials. 10. Patients who have short bowel(<200cm small bowel) or history of constipation. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Whole blood white blood cell(WBC) count on postoperative day 1 and 3 | whole blood white blood cell (WBC) count(*109/L) | postoperative day 1 and 3 | No |
Other | Whole blood neutrophil percentage on postoperative day 1 and 3 | neutrophil percentage(%) | postoperative day 1 and 3 | No |
Other | Whole blood platelet level on postoperative day 1 and 3 | platelet level(*109/L) | postoperative day 1 and 3 | No |
Other | Serum C-reactive protein(CRP) level on postoperative day 1 and 3. | CRP level(mg/dL) | postoperative day 1 and 3 | No |
Other | Serum interleukin-6(IL-6) level on postoperative day 1 and 3. | IL-6(pg/ml) | postoperative day 1 and 3 | No |
Other | Serum procalcitonin(PCT) level on postoperative day 1 and 3. | PCT(ug/L) | postoperative day 1 and 3 | No |
Primary | Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool | up to 30 days after surgery | No | |
Secondary | Time of first passing flatus reported by the patients(hours) | up to 30 days after surgery | No | |
Secondary | Time to resume solid diet or total enteral nutrition(TEN)(days) | up to 30 days after surgery | No | |
Secondary | Length of postoperative hospital stay (LOS)(days) | participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days | No | |
Secondary | Overall post-operative complication rate defined according to the Clavien-Dindo Classification | up to 30 days after surgery | No | |
Secondary | Overall cost (RMB) | participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days | No | |
Secondary | Pain scores on visual analogue scale (from 0 which implies no pain at all, to 10 which implies the worst pain imaginable) on the first 3 postoperative days and postoperative analgesic requirement (number of doses on 50-mg Pethidine) | up to postoperative day 3 | No | |
Secondary | Time to walk independently(days) | up to 30 days after surgery | No | |
Secondary | Hospital Readmission Rates Post 30-day Discharge | up to 30 days after discharge | No | |
Secondary | Length of postoperative ICU stay (days) | up to 30 days after surgery | No | |
Secondary | Incidence of adverse events related to drug usage | Diarrhoea,Flatulence,Nausea,Abdominal pain,Headaches,Menstrual disorder,Dizziness ,Skeletal pain,ECG nodal arrhythmia | up to 7 days after drug usage | Yes |
Secondary | Reinsertion of nasogastric tube | up to 30 days after surgery | No |
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