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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
25/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/08/2020
Sample size
Target
Accrual to date
Final
150
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.

Results not provided in https://clinicaltrials.gov/study/NCT02947269