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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] 299639 0
None
Universal Trial Number (UTN)
U1111-1238-3631
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anastomotic leak 313978 0
Condition category
Condition code
Surgery 312377 312377 0 0
Other surgery
Oral and Gastrointestinal 313303 313303 0 0
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] 315250 0
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] 321010 0
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] 321010 0

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] 376189 0
Safety of flushing rectal tubes with Gastrografin assessed by clinical examination (reported in medical records)
Timepoint [1] 376189 0
Day 1 post surgery
Day 2 post surgery
Day 3 post surgery
Day 4 post surgery
Day 5 post surgery
Secondary outcome [2] 376867 0
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] 376867 0
Within 5 days of surgery while patient is in hospital
Secondary outcome [3] 376868 0
Return of gastrointestinal function assessed by clinical examination
Timepoint [3] 376868 0
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?
No
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
20
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15049 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 28338 0
4032 - Chermside
Recruitment postcode(s) [2] 28339 0
4032 - Chermside Centre

Funding & Sponsors
Funding source category [1] 303516 0
Self funded/Unfunded
Name [1] 303516 0
Country [1] 303516 0
Primary sponsor type
Hospital
Name
Holy Spirit Northside Private Hospital
Address
627 Rode Road,
Chermside. 4032
Brisbane. QLD
Country
Australia
Secondary sponsor category [1] 303574 0
University
Name [1] 303574 0
The University of Sydney
Address [1] 303574 0
SOuRCe
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country [1] 303574 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304040 0
St Vincents Aged and Health HREC
Ethics committee address [1] 304040 0
627 Rode Road
Chermside
QLD 4032
Ethics committee country [1] 304040 0
Australia
Date submitted for ethics approval [1] 304040 0
18/12/2018
Approval date [1] 304040 0
20/12/2018
Ethics approval number [1] 304040 0
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 95626 0
A/Prof David A Clark
Address 95626 0
Holy Spirit Northside Private Hospital
627 Rode Road
Chermside QLD 4032
Country 95626 0
Australia
Phone 95626 0
+61 7 3350 2088
Fax 95626 0
+61 7 3350 2333
Email 95626 0
[email protected]
Contact person for public queries
Name 95627 0
Aleks Edmundson
Address 95627 0
Level 9
University of QLD
Faculty of Medicine (Central Clinical School)
Health Sciences Building
Butterfield Road
Herston. Queensland 4029.
Country 95627 0
Australia
Phone 95627 0
+61733465169
Fax 95627 0
+61 7 3350 2333
Email 95627 0
[email protected]
Contact person for scientific queries
Name 95628 0
Aleks Edmundson
Address 95628 0
Level 9
University of QLD
Faculty of Medicine (Central Clinical School)
Health Sciences Building
Butterfield Road
Herston. Queensland 4029.
Country 95628 0
Australia
Phone 95628 0
+61733465169
Fax 95628 0
+61 7 3350 2333
Email 95628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not permitted by HREC


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3939Study 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
SourceTitleYear of PublicationDOI
EmbaseA development study of drain fluid gastrografin as a biomarker of anastomotic leak.2022https://dx.doi.org/10.3393/ac.2020.12.24
N.B. These documents automatically identified may not have been verified by the study sponsor.