Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000691549
Ethics application status
Approved
Date submitted
22/06/2015
Date registered
2/07/2015
Date last updated
6/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Foley Catheter insertion into Defunctioning ileostomy
To reduce Postoperative Ileus after Major Colorectal Surgery
Scientific title
Foley Catheter insertion into Defunctioning ileostomy
To reduce Postoperative Ileus after Major Colorectal Surgery
Secondary ID [1] 286949 0
nil known
Universal Trial Number (UTN)
U1111-1170-0164
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 295397 0
Post operative ileus 295398 0
Condition category
Condition code
Oral and Gastrointestinal 295656 295656 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 295709 295709 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If randomized to treatment arm a Foley catheter is inserted into the proximal efferent limb of the ileostomy at the end of the operation. The Foley catheter will remain insitu for 5 days post operation.
Intervention code [1] 292150 0
Treatment: Devices
Intervention code [2] 292196 0
Treatment: Surgery
Comparator / control treatment
In the standard of care arm the patient receives the usual standard surgery and no Foley catheter is inserted
Control group
Active

Outcomes
Primary outcome [1] 295365 0
Time taken to tolerate low residue diet without nausea/vomiting. Assessed by clinical observation. Nursing notes and fluid/ bowel charts and patient self reporting.
Timepoint [1] 295365 0
5 days or until hospital discharge
Secondary outcome [1] 315433 0
Time taken until stoma output as measured by nursing fluid and bowel charts, patient communication and clinical assessment
Timepoint [1] 315433 0
5 days or until hospital discharge
Secondary outcome [2] 315533 0
Time taken until flatus passed as measured by nursing fluid and bowel charts, patient communication and clinical assessment
Timepoint [2] 315533 0
Up to 5 days post operation
Secondary outcome [3] 315534 0
Total length of hospital stay
Timepoint [3] 315534 0
until discharged
Secondary outcome [4] 315535 0
Incidence of adverse events measured by ckinical assessment, patient communication and nursing medical notes.
Timepoint [4] 315535 0
Until discharged from hospital
Secondary outcome [5] 315536 0
Incidence of adverse events and complications related to post operative ileus, measured by clinical assessment, nursing medical notes and patient communication.
Timepoint [5] 315536 0
Until hospital discharge

Eligibility
Key inclusion criteria
Subjects over 18 years of age, requiring elective or acute Colorectal surgery with a defunctioning loop ileostomy
English speaking, if not then must have an interpreter
Subjects must be willing to participate in the study and to provide written informed consent
Entering the Enhanced Recovery After Surgery (ERAS) programme as per standard hospital policy
Patients with malignant and non-malignant disease will be included
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects with any intraoperative findings identified by the surgeon that may preclude conduct of the study procedure
Involved in another colorectal study
Subjects unable to maintain the ERAS programme post operatively
If Foley catheter falls out the investigators will only re-insert Foley 3 times with the patient’s permission. After that the patient will be excluded from study. This will be done by the surgical registrar,consultant or research nurse.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each patient randomly allocated onto treatment arm. There are 6 Colorectal surgeons and 1 Colorectal fellow at North Shore Hospital. The random generated number will be created for each surgeon i.e. each surgeon will be provided a random list to account for inter surgeon variability and also differing number of ileostomies each surgeon performs.
On the day of surgery patients who have given written informed consent are randomly allocated into either the treatment or standard of care group by the research nurse by opening the randomization envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Biostatistician provides a random computer generated random number generated list
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2015
Actual
4/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6988 0
New Zealand
State/province [1] 6988 0
Auckland

Funding & Sponsors
Funding source category [1] 291509 0
Hospital
Name [1] 291509 0
North Shore Hospital Colorectal Research Department
Country [1] 291509 0
New Zealand
Primary sponsor type
Hospital
Name
North Shore Hospital Colorectal Research Department
Address
Shakespeare Road, Takapuna. Auckland 0740
Country
New Zealand
Secondary sponsor category [1] 290190 0
None
Name [1] 290190 0
Address [1] 290190 0
Country [1] 290190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293049 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 293049 0
Ethics committee country [1] 293049 0
New Zealand
Date submitted for ethics approval [1] 293049 0
19/05/2015
Approval date [1] 293049 0
09/06/2015
Ethics approval number [1] 293049 0
15/NTB/91

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 508 508 0 0
/AnzctrAttachments/368796-PARTICIPANT_INFORMATION_SHEET.CLEAN.[1].docx
Attachments [2] 509 509 0 0
/AnzctrAttachments/368796-foley 1.complete protocol.docx

Contacts
Principal investigator
Name 58242 0
Dr Suheelan Kulasegaran
Address 58242 0
North Shore Hospital, Private Bag 93-503, Takapuna, Auckland 0740
Country 58242 0
New Zealand
Phone 58242 0
+64 021 994 707
Fax 58242 0
Email 58242 0
[email protected]
Contact person for public queries
Name 58243 0
Suheelan Kulasegaran
Address 58243 0
North Shore Hospital, Private Bag 93-503, Takapuna, Auckland 0740
Country 58243 0
New Zealand
Phone 58243 0
+64 021 994 707
Fax 58243 0
Email 58243 0
[email protected]
Contact person for scientific queries
Name 58244 0
Suheelan Kulasegaran
Address 58244 0
North Shore Hospital, Private Bag 93-503, Takapuna, Auckland 0740
Country 58244 0
New Zealand
Phone 58244 0
+64 021 994 707
Fax 58244 0
Email 58244 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProphylactic Foley catheter insertion into defunctioning ileostomy to reduce obstruction after colorectal surgery: pilot randomized controlled trial.2020https://dx.doi.org/10.1111/ans.15714
N.B. These documents automatically identified may not have been verified by the study sponsor.