ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Colorectal cancer

Anastomotic leak

Condition category

Condition code

Surgery

Other surgery

Cancer

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]

Early Detection / Screening

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Day 1, Day 2, Day 3, Day 4 and Day 5, post operatively, or until pelvic drain is removed.

Secondary outcome [1]

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]

- 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]

Serum CRP

Timepoint [2]

Day 3 post-operative

Secondary outcome [3]

Hospital Length of Stay (LOS), documented in discharge Summary (medical records)

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Holy Spirit Northside - Chermside

Recruitment hospital [2]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4032 - Chermside

Recruitment postcode(s) [2]

4029 - Herston

Recruitment postcode(s) [3]

4032 - Chermside Centre

Recruitment postcode(s) [4]

4029 - Royal Brisbane Hospital

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Private Hospital Northside

Address [1]

627 Rode Road Chermside QLD 4032

Country [1]

Australia

Primary sponsor type

Hospital

Name

Holy Spirit Private Hospital Northside

Address

627 Rode Road
Chemside
QLD 4032

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent’s Health and Aged Care Human Research Ethics Committee (EC00324)

Ethics committee address [1]

627 Rode Road
Chermside QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/06/2019

Approval date [1]

18/07/2019

Ethics approval number [1]

HREC 19/14

Ethics committee name [2]

Royal Brisbane and Women's Hospital Human Research Ethics Committee (EC00172)

Ethics committee address [2]

Royal Brisbane & Women’s Hospital
Executive Suites, Lower Ground Floor
Dr James Mayne Building
Butterfield Street, Herston Qld 4029
Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

26/06/2020

Approval date [2]

15/07/2020

Ethics approval number [2]

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

A/Prof David Clark

Address

St Vincent’s Private Hospital Northside 627 Rode Road Chermside. 4032 Brisbane. Qld. AUSTRALIA

Country

Australia

Phone

+61 07 33502088

Fax

[email protected]

Contact person for public queries

Name

Aleksandra Edmundson

Address

Surgery Royal Brisbane Women's Hospital Butterfield Street Herston QLD 4029

Country

Australia

Phone

+61 07 3646 8314

Fax

[email protected]

Contact person for scientific queries

Name

David Clark

Address

St Vincent’s Private Hospital Northside 627 Rode Road Chermside. 4032 Brisbane. Qld. AUSTRALIA

Country

Australia

Phone

+61 07 33502088

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No 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

Current Study Results

No documents have been uploaded by study researchers.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
5312	Other files	Yes	https://doi.org/10.1111/ans.17461	https://onlinelibrary.wiley.com/doi/epdf/10.1111/a... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically