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Trial registered on ANZCTR

Registration number

ACTRN12619001687189

Ethics application status

Approved

Date submitted

9/08/2019

Date registered

2/12/2019

Date last updated

2/12/2019

Date data sharing statement initially provided

2/12/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

The validation of Gastrografin measurement in postsurgical samples following low anterior resection where the rectal tube is flushed with Gastrografin: A Phase 1 biomarker feasibility study

Scientific title

The validation of Gastrografin measurement in postsurgical samples following low anterior resection where the rectal tube is flushed with Gastrografin: A Phase 1 biomarker feasibility study

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1238-3631

Trial acronym

Linked study record

Health condition

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

anastomotic leak

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The first 10 consecutive patients fitting the eligibility criteria were invited to participate and allocated into the Control Group (rectal tubes flushed with saline 4 times per day (standard care)).
The next 10 consecutive patients fitting the eligibility criteria were allocated into the Intervention Group (rectal tubes flushed with 30 ml of Gastrografin 4 times per day). All invited patients were presented with study information and the requirements of participation. Participation involved providing written consent, to access their medical records, the flushing of rectal tubes with saline/Gastrografin and the collection of 10-20ml drain fluid at Day 1, Day 2, Day 3, Day 4, Day 5 (or until drain is in situ)

Gastrografin flushes delivered by rectal tube
1. 30 ml Gastrografin per flush
2. Four (4) flushes per day
3. Nursing staff administer Gastrografin flushes
4. Hospital progress notes document administration of flushes. Research document (CRF) document flushes
5. Consecutive patients fitting the selection criteria

Intervention code [1]

Early detection / Screening

Comparator / control treatment

All invited patients were presented with study information and the requirements of participation. Participation involved providing written consent, to access their medical records, the flushing of rectal tubes with saline/Gastrografin and the collection of 10-20ml drain fluid at Day 1, Day 2, Day 3, Day 4, Day 5 (or until drain is in situ)
Saline flushes of rectal tube
1. 30 mls of saline per flush
2. Four (4) flushes per day
3. Nuring staff admisnister saline flushes
4. Saline flushes are standrad care for patients with rectal tubes placement. Rectal tube placement is documented in patient hopital chart

Control group

Active

Outcomes

Primary outcome [1]

Ability of Duel Energy - Computed tomography (DECT) to quantitate Gastrografin (Iodine)
Outcome assessed by measurement of Iodine in Gastrografin
Detection of Gastrografin by DECT in post-operative drain fluid of patients experiencing an anastomotic leak

Timepoint [1]

Measurement of Gastrografin in the drain fluid daily while rectal and drain tube in situ, post operatively.
Day 1 post surgery, Day 2 post surgery(#), Day 3 post surgery (#), Day 4 post surgery (possible Day 5 post surgery)
(#) indicates primary endpoint, an increase in amylase level on the day of anastomotic leak

Secondary outcome [1]

Safety of flushing rectal tubes with Gastrografin assessed by clinical examination (reported in medical records)

Timepoint [1]

Day 1 post surgery
Day 2 post surgery
Day 3 post surgery
Day 4 post surgery
Day 5 post surgery

Secondary outcome [2]

Return to theatre to repair complication (anastomotic leak)
Anastomotic leak assessed by clinical examination and detected by the presence of Gastrografin in the drain fluid

Timepoint [2]

Within 5 days of surgery while patient is in hospital

Secondary outcome [3]

Return of gastrointestinal function assessed by clinical examination

Timepoint [3]

6 weeks post surgery, follow up appointment with treating surgeon

Eligibility

Key inclusion criteria

low or ultra-low anterior resection
no covering loop ileostomy

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

covering loop ileostomy
allergy to Gastrografin (Iodine)

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Non-randomised 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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other

Other design features

The first 10 patients are administered saline flushes of their rectal tubes. . Next 10 are administered Gastrografin flushes.

Phase

Phase 1

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

descriptive statistics will be used to evaluate the tolerability and safety Gastrografin Flushes post surgery. The sample size for this early phase study will be too low to perform statistical analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

5/02/2019

Date of last participant enrolment

Anticipated

1/12/2019

Actual

Date of last data collection

Anticipated

1/01/2020

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Holy Spirit Northside - Chermside

Recruitment postcode(s) [1]

4032 - Chermside

Recruitment postcode(s) [2]

4032 - Chermside Centre

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Holy Spirit Northside Private Hospital

Address

627 Rode Road,
Chermside. 4032
Brisbane. QLD

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Sydney

Address [1]

SOuRCe
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincents Aged and Health HREC

Ethics committee address [1]

627 Rode Road
Chermside
QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/12/2018

Approval date [1]

20/12/2018

Ethics approval number [1]

HREC 19/01

Summary

Brief summary

Project Summary

Anastomotic leakage (AL) is a serious complication of intestinal surgery, resulting in increased morbidity and mortality. Current approaches to early detection of AL are nonspecific and insensitive. As a consequence, AL are often diagnosed at a later stage with the presentation of clinical symptoms and often secondary complications.  In our subsequent studies we propose utilising a commonly used radiological solution, Gastrografin, as a biomarker of early detection of AL.

Gastrografin is a water soluble, contrast solution commonly used for abdominal CT (computer tomography).  In clinical practice, when administered orally or as an enema Gastrografin acts as a radiological contrast for the detection anastomotic leaks.  It is also employed in regular clinical practice in small bowel obstruction and ileus.

Our feasibility study aims to assess safety and optimise the technique and conditions required to reliably detect Gastrografin in surgical samples by Dual Emission CT (DECT)

The outcomes of this Phase 1 feasibility study and the separate validation study are important in the development of the standard operating protocols for our proposed main study “Drain fluid Gastrografin as a sensitive biomarker for early detection of anastomotic leaks after low anterior resection”.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David A Clark

Address

Holy Spirit Northside Private Hospital
627 Rode Road
Chermside QLD 4032

Country

Australia

Phone

+61 7 3350 2088

Fax

+61 7 3350 2333

[email protected]

Contact person for public queries

Name

Aleks Edmundson

Address

Level 9
University of QLD
Faculty of Medicine (Central Clinical School)
Health Sciences Building
Butterfield Road
Herston. Queensland 4029.

Country

Australia

Phone

+61733465169

Fax

+61 7 3350 2333

[email protected]

Contact person for scientific queries

Name

Aleks Edmundson

Address

Level 9
University of QLD
Faculty of Medicine (Central Clinical School)
Health Sciences Building
Butterfield Road
Herston. Queensland 4029.

Country

Australia

Phone

+61733465169

Fax

+61 7 3350 2333

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

Not permitted by HREC

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3939	Study protocol					378142-(Uploaded-09-08-2019-15-01-03)-Study-related document.docx

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	A development study of drain fluid gastrografin as a biomarker of anastomotic leak.	2022	https://dx.doi.org/10.3393/ac.2020.12.24

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

Trial Review

Documents added manually

Documents added automatically