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Prucalopride for Postoperative Ileus in Patients Undergoing Gastrointestinal Surgery

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ClinicalTrials.gov Identifier: NCT02004652
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postoperative Ileus Drug: Prucalopride Drug: Placebo Phase 2

Detailed Description:

Postoperative ileus (POI), an interruption of bowel motility function, virtually occurs in all patients undergoing major gastrointestinal(GI) surgery. This functional impairment persists for a variable duration, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. Therefore, time of return of colonic function is the the major determinant of duration of POI. Attempts to reduce the duration of POI have prompted the implementation of fast track surgery including early removal of the nasogastric tube, early feeding, alvimopan, gum chewing, and prompt ambulation. However, it is still reported to be more than 4-5 days in most of the randomized trial. Therefore, methods specifically aiming at promoting postoperative colon motility may further enhance the GI function recovery, and prucalopride may be one of the options.

Prucalopride, a substituted benzamide with selective 5-HT4 agonist activity, has been shown previously to significant improve colon motility and transit, but it only has mild effect on gastric or small bowel transit. The drug is well tolerated with no significant adverse effects. Recently, prucalopride has been approved in Europe and America for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. However, its usage in the postoperative period has not been tested. This study will test the ability and safety of prucalopride given 24hrs after GI surgery to hasten the recovery of GI function.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Double-blind Efficacy and Tolerability Study Of Prucalopride For The Treatment Of Postoperative Ileus In Patients Undergoing Gastrointestinal Surgery
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Prucalopride
Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
Drug: Prucalopride
Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
Other Name: Resolor

Placebo Comparator: Placebo
Vitamin C, 50mg, tablet
Drug: Placebo
Vitamin, 50mg, tablet.




Primary Outcome Measures :
  1. Time to defaecation, measured in hours, from the time the surgery ends till the first observed passage of stool [ Time Frame: up to 30 days after surgery ]

Secondary Outcome Measures :
  1. Time of first passing flatus reported by the patients(hours) [ Time Frame: up to 30 days after surgery ]
  2. Time to resume solid diet or total enteral nutrition(TEN)(days) [ Time Frame: up to 30 days after surgery ]
  3. Length of postoperative hospital stay (LOS)(days) [ Time Frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days ]
  4. Overall post-operative complication rate defined according to the Clavien-Dindo Classification [ Time Frame: up to 30 days after surgery ]
  5. Overall cost (RMB) [ Time Frame: participants will be followed for the duration of postoperative hospital stay, an expected average of 8 days ]
  6. 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) [ Time Frame: up to postoperative day 3 ]
  7. Time to walk independently(days) [ Time Frame: up to 30 days after surgery ]
  8. Hospital Readmission Rates Post 30-day Discharge [ Time Frame: up to 30 days after discharge ]
  9. Length of postoperative ICU stay (days) [ Time Frame: up to 30 days after surgery ]
  10. Incidence of adverse events related to drug usage [ Time Frame: up to 7 days after drug usage ]
    Diarrhoea,Flatulence,Nausea,Abdominal pain,Headaches,Menstrual disorder,Dizziness ,Skeletal pain,ECG nodal arrhythmia

  11. Reinsertion of nasogastric tube [ Time Frame: up to 30 days after surgery ]

Other Outcome Measures:
  1. Whole blood white blood cell(WBC) count on postoperative day 1 and 3 [ Time Frame: postoperative day 1 and 3 ]
    whole blood white blood cell (WBC) count(*109/L)

  2. Whole blood neutrophil percentage on postoperative day 1 and 3 [ Time Frame: postoperative day 1 and 3 ]
    neutrophil percentage(%)

  3. Whole blood platelet level on postoperative day 1 and 3 [ Time Frame: postoperative day 1 and 3 ]
    platelet level(*109/L)

  4. Serum C-reactive protein(CRP) level on postoperative day 1 and 3. [ Time Frame: postoperative day 1 and 3 ]
    CRP level(mg/dL)

  5. Serum interleukin-6(IL-6) level on postoperative day 1 and 3. [ Time Frame: postoperative day 1 and 3 ]
    IL-6(pg/ml)

  6. Serum procalcitonin(PCT) level on postoperative day 1 and 3. [ Time Frame: postoperative day 1 and 3 ]
    PCT(ug/L)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004652


Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Principal Investigator: Jianfeng Gong, MD Department of general surgery,Jinling hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jianfeng Gong, Associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02004652     History of Changes
Other Study ID Numbers: RIGS-2013-PRU
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Prucalopride
Gastrointestinal Diseases
Postoperative ileus
Randomised trial

Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Prucalopride
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs