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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
Scientific title
A Randomized Double-blind Placebo Controlled Trial of Prucalopride to Reduce the Duration of Postoperative Ileus in Patients Undergoing Elective Colorectal Surgery
Secondary ID [1] 0 0
UOA-prucRCT1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Ileus 0 0
Colorectal Surgery 0 0
Postoperative Complications 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time until recovery of gastrointestinal function
Timepoint [1] 0 0
From date of surgery until discharge from hospital (14 days on average)
Secondary outcome [1] 0 0
Time until passage of stool (in days)
Timepoint [1] 0 0
From date of surgery until discharge from hospital (14 days on average)
Secondary outcome [2] 0 0
Time until passage of flatus (in days)
Timepoint [2] 0 0
From date of surgery until discharge from hospital (14 days on average)
Secondary outcome [3] 0 0
Time until tolerance of solid oral diet (in days)
Timepoint [3] 0 0
From date of surgery until discharge from hospital (14 days on average)
Secondary outcome [4] 0 0
Presence of prolonged postoperative ileus
Timepoint [4] 0 0
From date of surgery until discharge from hospital (14 days on average)
Secondary outcome [5] 0 0
Levels of serum inflammatory markers (in pg/mL)
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).
Secondary outcome [6] 0 0
Length of postoperative stay (in days)
Timepoint [6] 0 0
From date of surgery until discharge from hospital (14 days on average)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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.