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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02947269




Registration number
NCT02947269
Ethics application status
Date submitted
23/10/2016
Date registered
27/10/2016
Date last updated
27/10/2017

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
Surgery 0 0 0 0
Other surgery
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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 - 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.
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 - 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.
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) - Markers to be tested: CRP, IL1beta, IL6, IL8, IL12, TNFalpha
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
Gender
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
Recruiting
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
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.
Trial website
https://clinicaltrials.gov/show/NCT02947269
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
Ian P Bissett, MD, FRACS
Address 0 0
Country 0 0
Phone 0 0
+649 373 7599
Fax 0 0
Email 0 0
i.bissett@auckland.ac.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02947269