Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000057886
Ethics application status
Approved
Date submitted
13/11/2020
Date registered
22/01/2021
Date last updated
22/01/2021
Date data sharing statement initially provided
22/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Drain Fluid Amylase as an early biomarker of anastomotic leak in low colorectal anastomoses
Scientific title
Drain Fluid Amylase and Lipase as early biomarkers of anastomotic leak in low colorectal anastomoses
Secondary ID [1] 302787 0
Nil known
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 319729 0
Anastomotic leak 319730 0
Condition category
Condition code
Surgery 317665 317665 0 0
Other surgery
Cancer 318037 318037 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measure amylase levels in drain fluid daily after low colorectal anastomoses as an early indicator of anastomotic leak.
- a small sample of drain fluid will be collected daily while pelvic drain is in situ during hospital admission following colorectal surgery and samples will be sent to the local pathology service for measurement of amylase
- the amylase levels in drain fluid at each collection while the drain is in-situ will be collected and correlated to the clinical course
- clinical course following surgery will be observed during admission (and data collected after patient has been discharged, retrospective data collection).
- Follow up consultation at 6 weeks following surgery
Intervention code [1] 319063 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325715 0
Daily amylase levels in the drain fluid post-operatively. The measurement of amylase in drain fluid is measured and reported by local pathology service.
Timepoint [1] 325715 0
Day 1, Day 2, Day 3, Day 4 and Day 5, post operatively, or until pelvic drain is removed.
Secondary outcome [1] 388891 0
Clinical course (anastomotic leak) following surgery is assessing by treating surgeon as per standard clinical practice (including daily observation of vital signs). Clinical observations are documented in patient medical chart.
Timepoint [1] 388891 0
- Amylase levels will be observed daily following surgery until pelvic drain is removed
- Follow up appointment with treating surgeon at 6 weeks after surgery will be reported
Secondary outcome [2] 388892 0
Serum CRP
Timepoint [2] 388892 0
Day 3 post-operative
Secondary outcome [3] 388893 0
Hospital Length of Stay (LOS), documented in discharge Summary (medical records)
Timepoint [3] 388893 0
Day of discharge

Eligibility
Key inclusion criteria
Low and ultra low colorectal surgery without a covering loop ileostomy
Placement of a rectal tube
Placement of a pelvic drain at surgery
Any indication requiring low pelvic colorectal anastomosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18 years
Inability to give consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive analysis
Chi squared analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/07/2019
Date of last participant enrolment
Anticipated
30/07/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
50
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18025 0
Holy Spirit Northside - Chermside
Recruitment hospital [2] 18026 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 31996 0
4029 - Herston
Recruitment postcode(s) [2] 31998 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [3] 31995 0
4032 - Chermside
Recruitment postcode(s) [4] 31997 0
4032 - Chermside Centre

Funding & Sponsors
Funding source category [1] 307210 0
Hospital
Name [1] 307210 0
St Vincent's Private Hospital Northside
Country [1] 307210 0
Australia
Primary sponsor type
Hospital
Name
Holy Spirit Private Hospital Northside
Address
627 Rode Road
Chemside
QLD 4032
Country
Australia
Secondary sponsor category [1] 307814 0
None
Name [1] 307814 0
None
Address [1] 307814 0
None
Country [1] 307814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307310 0
St Vincent’s Health and Aged Care Human Research Ethics Committee (EC00324)
Ethics committee address [1] 307310 0
627 Rode Road
Chermside QLD 4032
Ethics committee country [1] 307310 0
Australia
Date submitted for ethics approval [1] 307310 0
10/06/2019
Approval date [1] 307310 0
18/07/2019
Ethics approval number [1] 307310 0
HREC 19/14
Ethics committee name [2] 307312 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee (EC00172)
Ethics committee address [2] 307312 0
Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Australia
Ethics committee country [2] 307312 0
Australia
Date submitted for ethics approval [2] 307312 0
26/06/2020
Approval date [2] 307312 0
15/07/2020
Ethics approval number [2] 307312 0
HREC/2020/QRBW/65975

Summary
Brief summary
Anastomotic leakage (AL) is a serious complication of intestinal surgery, resulting in increased morbidity and mortality. This study aims to explore the simple and non-invasive approach of measuring the enzymes amylase and lipase in the drain fluid following a low extra-peritoneal anastomosis to detect AL at an early stage in the post-operative recovery.

The hypothesis is based on the premise that luminal content of the colon is high in amylase and lipase and that drain fluid levels will rise above the normal serum reference range when an AL occurs.


Who is it for?
You may be eligible for this study if you are aged 18 or older, you have undergone a low or ultra low colorectal operation without a diverting loop ileostomy, and have had placement of a rectal tube and a pelvic drain at surgery. Patients undergoing the above surgical operations for any indication will be eligible for this study.

Study details
All participants enrolled in this study will have a sample of drain fluid collected daily from their surgical drain whilst the pelvic drain is in place. Insertion of pelvic drains is an element of the standard of care following colorectal surgery.

It is hoped this research will determine whether enzymes such as amylase and lipase in fluids drained from an intestinal surgical site can indicate whether a patient has experienced an AL from their intestinal join following surgery, at an earlier time point than when diagnosed based on clinical signs.
Trial website
None
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 106782 0
A/Prof David Clark
Address 106782 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside. 4032
Brisbane. Qld. AUSTRALIA
Country 106782 0
Australia
Phone 106782 0
+61 07 33502088
Fax 106782 0
NA
Email 106782 0
david.clark@doctors.org.uk
Contact person for public queries
Name 106783 0
Dr Aleksandra Edmundson
Address 106783 0
Surgery
Royal Brisbane Women's Hospital
Butterfield Street
Herston
QLD 4029
Country 106783 0
Australia
Phone 106783 0
+61 07 3646 8314
Fax 106783 0
NA
Email 106783 0
aleksandra.edmundson@uq.edu.au
Contact person for scientific queries
Name 106784 0
A/Prof David Clark
Address 106784 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside. 4032
Brisbane. Qld. AUSTRALIA
Country 106784 0
Australia
Phone 106784 0
+61 07 33502088
Fax 106784 0
NA
Email 106784 0
david.clark@doctors.org.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Human Research Ethics Committee approval is conditional on data security


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
No additional documents have been identified.