Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02947269
Registration number
NCT02947269
Ethics application status
Date submitted
23/10/2016
Date registered
27/10/2016
Date last updated
29/09/2021
Titles & IDs
Public title
Prucalopride in Postoperative Ileus
Query!
Scientific title
A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery
Query!
Secondary ID [1]
0
0
UOA-prucRCT1
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Postoperative Ileus
0
0
Query!
Colorectal Surgery
0
0
Query!
Postoperative Complications
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Surgery
0
0
0
0
Query!
Other surgery
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Prucalopride
Treatment: Drugs - Placebo Oral Capsule
Experimental: Intervention group - Patients will receive an oral capsule containing 2mg Prucalopride 2-3 hours preoperatively. Study medication (2mg oral Prucalopride daily) will continue for 6 days postoperatively or until the patient has achieved the study's primary outcome.
Placebo comparator: Placebo group - Patients will receive an oral capsule containing a placebo 2-3 hours preoperatively. Study medication (placebo) will continue for 6 days preoperatively or until the patient has achieved the study's primary outcome.
Treatment: Drugs: Prucalopride
Prucalopride 2mg capsule
Treatment: Drugs: Placebo Oral Capsule
Placebo capsule
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time until recovery of gastrointestinal function
Query!
Assessment method [1]
0
0
Recovery of GI function is defined by the later time point (in days) of time to passage of stool AND time to tolerance of a solid or semi-solid diet. Patients will be reviewed twice per day using a structured questionnaire.
Query!
Timepoint [1]
0
0
From date of surgery until discharge from hospital (14 days on average)
Query!
Secondary outcome [1]
0
0
Time until passage of stool (in days)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
From date of surgery until discharge from hospital (14 days on average)
Query!
Secondary outcome [2]
0
0
Time until passage of flatus (in days)
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
From date of surgery until discharge from hospital (14 days on average)
Query!
Secondary outcome [3]
0
0
Time until tolerance of solid oral diet (in days)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
From date of surgery until discharge from hospital (14 days on average)
Query!
Secondary outcome [4]
0
0
Presence of prolonged postoperative ileus
Query!
Assessment method [4]
0
0
Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.
Query!
Timepoint [4]
0
0
From date of surgery until discharge from hospital (14 days on average)
Query!
Secondary outcome [5]
0
0
Levels of serum inflammatory markers (in pg/mL)
Query!
Assessment method [5]
0
0
Markers to be tested: CRP, IL1beta, IL6, IL8, IL12, TNFalpha
Query!
Timepoint [5]
0
0
Inflammatory markers will be collected preoperatively, day 1 and 3 postoperatively. Blood samples will be stored after collection for later testing (up to 1 year).
Query!
Secondary outcome [6]
0
0
Length of postoperative stay (in days)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
From date of surgery until discharge from hospital (14 days on average)
Query!
Eligibility
Key inclusion criteria
* Adult patients from Auckland District Health Board catchment
* Age 18 or older
* Elective and subacute surgery
* Right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection, Hartmann's procedure, subtotal colectomy
* Operation with or without the formation of a colostomy
* Indication for operation: colon cancer, diverticular disease, gynaecological
* Able to understand risks and benefits of the study
* Able to give informed consent
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* ASA 4 or greater
* Allergy to any serotonin medication
* Active inflammatory bowel disease
* Planned formation of an ileostomy during surgery
* Moderate to severe renal impairment (Creatinine clearance<50mL/min/1.73m2)
* Severe hepatic impairment (Child-Pugh C)
* Pregnancy
* Pre-existing gut dysmotility disorder including endocrine, metabolic or neurological cause
* Pre-operative malnutrition requiring parenteral nutrition
* Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/10/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
30/08/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
150
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Auckland, New Zealand
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Postoperative ileus (POI) refers to the period of gut dysmotility that occurs after abdominal surgery. Patients with POI are unable to eat, suffer ongoing nausea and vomiting, are unable to open their bowels and have a prolonged hospital stay. Research at ADHB shows that 25% of patients will have a prolonged POI after elective bowel resection, which makes it the most common major complication after colorectal surgery. Clinicians currently lack a definitive medication to prevent or treat POI, which means POI causes patients ongoing morbidity and places a significant drain on healthcare resources. Serotonin plays an important role in gut motility. Evidence suggests that serotonin agonists, such as prucalopride, increase gut transit and may have anti-inflammatory properties. The hypothesis of this study is that Prucalopride given pre-operatively and continued post-operatively in patients having an elective bowel resection will improve gut function recovery after surgery and reduce POI. The investigators' proposed study is a double-blinded randomised controlled trial of prucalopride compared to an identical placebo tablet, in patients having an elective bowel resection at Auckland City Hospital. Patients will receive a single tablet of Prucalopride or placebo 2-3 hours preoperatively and then daily after operation for a maximum of 6 days. The primary endpoint will be return to bowel function defined by the time to tolerate a solid diet and pass stool. In addition, the investigators plan to assess postoperative gastric emptying rates using the safe and non-invasive carbon breath test method. This will allow the investigators to determine the effects of prucalopride on the stomach, and support its role as a gastric prokinetic.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02947269
Query!
Trial related presentations / publications
Milne T, Liu C, O'Grady G, Woodfield J, Bissett I. Effect of prucalopride to improve time to gut function recovery following elective colorectal surgery: randomized clinical trial. Br J Surg. 2022 Jul 15;109(8):704-710. doi: 10.1093/bjs/znac121.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02947269
Download to PDF