ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001665123

Ethics application status

Approved

Date submitted

7/08/2019

Date registered

28/11/2019

Date last updated

28/11/2019

Date data sharing statement initially provided

28/11/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Drain Fluid Amylase Testing to Identify Anastomotic Leak in Patients Undergoing Ileal Pouch Surgery without an ileostomy

Scientific title

Drain Fluid Amylase as a sensitive Biomarker of Anastomotic Leak in Ileal Pouch Surgery Without a Covering Loop Ileostomy

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1238-3570

Trial acronym

Linked study record

Clark, D. A., Cuda, T., Riddell, A., Radford-Smith, G., & Solomon, M. (2018). Drain fluid amylase as a sensitive biomarker for the early detection of anastomotic leakage in ileal pouch surgery. Colorectal Disease. 21(4), 460-464 The Official Journal of the Association of Coloproctology of Great Britain and Ireland,

This publication reports on the pilot phase (proof of principle) of the current study (Trial No:377982)

Health condition

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

inflammatory bowel disease

ileoanal anastomosis (J-pouch) surgery

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Inflammatory bowel disease

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Eligible patients are identified by treating colorectal surgeon and invited to participate in the study. Participants interested in participating in the study receive information about the study and asked to provide written consent before being included. Participants provide written consent to allow access to patient medical records and a daily collection of drain fluid (10 ml) and a sample (10 ml) from the rectal tube on Day 1 post operatively. The daily collection of drain fluid and rectal tube sample presents no additional risk, discomfort or inconvenience for participants. Participation is voluntary with the option of withdrawal at any stage without consequence.
Drain fluid samples are collected daily for 5 days (or until drain is removed, whichever is later) for measurement of amylase levels.

An increase in drain fluid amylase is expected in the case of anastomotic leak, at an earlier timepoint than current diagnostics.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

6 weeks post surgery follow up appointment with treating surgeon

Secondary outcome [2]

serum CRP

Timepoint [2]

Day 3 post operative
Day 5 post operative

Secondary outcome [3]

Hospital Length of Stay (LOS) is documented patient Discharge summary (medical records)

Timepoint [3]

Day of discharge

Eligibility

Key inclusion criteria

Ileal pouch surgery
no covering loop ileostomy
able to provide consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

covering loop ileostomy
under 18 years of age

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

descriptive statistics
Chai squared
Correlation
Samples size was calculated from a pilot study

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

27/08/2018

Date of last participant enrolment

Anticipated

31/08/2020

Actual

Date of last data collection

Anticipated

15/10/2020

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 hospital [3]

The Wesley Hospital - Auchenflower

Recruitment hospital [4]

Sunshine Coast University Hospital - Birtinya

Recruitment postcode(s) [1]

4032 - Chermside

Recruitment postcode(s) [2]

4029 - Herston

Recruitment postcode(s) [3]

4066 - Auchenflower

Recruitment postcode(s) [4]

4575 - Birtinya

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Brisbane Hospital

Address [1]

Butterfield Street
Herston QLD 4029

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Brisbane Hospital

Address

Butterfield St
Herston QLD 4029

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Sydney

Address [1]

50 Missenden Road
Camperdown NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane Women's Hospital HREC

Ethics committee address [1]

Royal Brisbane Women's Hospital HREC [EC00172]
Executive Suites
Dr James Mayne Building
Butterfield Street
Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

14/06/2018

Ethics approval number [1]

Summary

Brief summary

Anastomotic leakage (AL) is the most significant complication in any intestinal operation with an anastomosis. Much work has gone into identifying patients at higher risk of AL pre-operatively . Early post-operative detection is also important, and a body of work has examined inflammatory markers, lipopolysaccharides and drain fluid proteins in patients undergoing colorectal anastomoses.   

In patients undergoing restorative proctocolectomy and ileal pouch anal anastomosis (RP   A drain is commonly placed to the pelvis during RP IPAA. This provides an opportunity to study the contents of the drain fluid in a simple and non-invasive way.

As the luminal contents of the small intestine are high in amylase, we wished to study its measurement in drain fluid as a biomarker of AL. 

Ileal pouch surgery presents a unique opportunity to utilize drain fluid amylase (DFA) as a biomarker to detect anastomotic leakage when a defunctioning ileostomy is not employed. We hypothesize that a substantial rise in DFA is a sensitive biomarker of anastomotic leak. The primary aim is to evaluate the utility of measuring amylase in drain fluid and to relate this to the clinical post operative course. The secondary aim is to quantitate the intra-luminal values of amylase within the ileal pouch.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David A Clark

Address

St Vincent's Private Hospital Northside
627 Rode Road
Chermside QLD 4032

Country

Australia

Phone

+61 733502088

Fax

61733465169

David.Clark@doctors.org.uk

Contact person for public queries

Name

Aleks Edmundson

Address

University of Qld
Health Sciences Building
Butterfield Street
Herston. QLD 4029

Country

Australia

Phone

+61 733465169

Fax

aleksandra.edmundson@uq.edu.au

Contact person for scientific queries

Name

David A Clark

Address

St Vincent's Private Hospital Northside
627 Rode Road
Chermside. QLD 4032

Country

Australia

Phone

+61 733502088

Fax

61733465169

David.Clark@doctors.org.uk

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

HREC approval prevents identifiable patient data to be available

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3875	Ethical approval					377982-(Uploaded-07-08-2019-18-34-35)-Study-related document.pdf
5490	Study protocol			aleksandra.edmundson@uq.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Multicenter Study of Drain Fluid Amylase as a Biomarker for the Detection of Anastomotic Leakage after Ileal Pouch Surgery Without a Diverting Ileostomy.	2022	https://dx.doi.org/10.1097/DCR.0000000000002376

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically