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Trial registered on ANZCTR


Registration number
ACTRN12620000710921p
Ethics application status
Submitted, not yet approved
Date submitted
20/04/2020
Date registered
29/06/2020
Date last updated
29/06/2020
Date data sharing statement initially provided
29/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 2 study of efficacy: The validation of Gastrografin measurement in postsurgical samples following low anterior resection when the rectal tube is flushed with Gastrografin
Scientific title
A Phase 2 study of efficacy: The validation of Gastrografin measurement in postsurgical samples following low anterior resection when the rectal tube is flushed with Gastrografin
Secondary ID [1] 301072 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anterior rectal resection 317134 0
colorectal cancer 317135 0
Condition category
Condition code
Surgery 315289 315289 0 0
Other surgery
Cancer 315290 315290 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who undergo low anterior resection without a diverting loop ileostomy and have a rectal tube and pelvic drain will be invited to participate.

Only participants who are included in the study (by providing written consent) will receive Gastrografin flushes of rectal tube four times per day (QID), to replace saline flushes QID.

At Day 1, Day 2, Day 3, Day 4, Day 5 (or until rectal tubes is in situ) after surgery:
Participants will receive rectal tube flushing with 30 ml Gastrografin (25% v/v in saline) 4 times per day (QID). At 06:30am and 16:30pm, a 20 ml sample of drain fluid will be collected and stored until all samples during hospital admission are collected (for measurement of Gastrografin by DECT and ICPMS). Also, a sample from the rectal tube will be collected on Day 1 after surgery to confirm the presence of luminal Gastrografin. Patients will be observed during the hopital admission following surgery.

The presence of Gastrografin will be measured in each sample by DECT and ICPMS.
The clinical course post surgery will be monitored in all participants and the group will be catagorised into patients that DO NOT experience an anastomotic leak following surgery and patients that DO experience an anastomotic leak following surgery.






Intervention code [1] 317376 0
Early detection / Screening
Comparator / control treatment
The control group will be participants who DO NOT experience an anastomotic leak following surgery.
Control group
Active

Outcomes
Primary outcome [1] 323533 0
Level of Gastrografin in drain fluid will be measured by DECT and ICP-MS
Timepoint [1] 323533 0
Day 1, 2, 3, 4, 5 or until rectal tube is in situ
Primary outcome [2] 323534 0
Anastomotic leak after surgery by clinical assessment and CT (as per standard care)
Timepoint [2] 323534 0
Day 1, 2, 3, 4, 5 post surgery
Secondary outcome [1] 382181 0
Blood tests (Full Blood Count, (FBC)) to assess clinical state after surgery, FBC levels outside normal reference range may indicate anastomotic leak
Timepoint [1] 382181 0
Day 3 post operation
Secondary outcome [2] 382845 0
Blood Test (C-Reactive Protein (CRP)), an elevation of CRP following surgery to assess clinical course (may contribute to the diagnosis of anastomotic leak)
Timepoint [2] 382845 0
Day 3 post operation

Eligibility
Key inclusion criteria
Inclusion Criteria

Patients undergoing rectal resection and extra-peritoneal anastomosis without a diverting loop ileostomy
Placement of a rectal tube in the neo-rectum
Placement of a pelvic drain at surgery
Satisfactory anastomosis at surgery
Indication for surgery may include benign or malignant disease



Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Age less than 18 years
Inability to give written consent
Proctocolectomy and ileal pouch surgery
Allergy to 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)
A unique numeric code will be allocated to each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Consecutive eligible patients will be invited to participate.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Statistical methods such as student t-test, ROC, and descriptive statistics will be utilised to analyse the data.
Data will be represented using graphs and tables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16497 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 16498 0
Holy Spirit Northside - Chermside
Recruitment hospital [3] 16508 0
The Wesley Hospital - Auchenflower
Recruitment postcode(s) [1] 30053 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 30054 0
4032 - Chermside
Recruitment postcode(s) [3] 30055 0
4029 - Herston
Recruitment postcode(s) [4] 30065 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 305512 0
Hospital
Name [1] 305512 0
Royal Brisbane Women's Hospital
Address [1] 305512 0
Royal Brisbane Women's Hospital
Butterfield Street
HERSTON
QLD 4029
Australia
Country [1] 305512 0
Australia
Primary sponsor type
Individual
Name
A/Prof David Clark
Address
Holy Spirit Northside Private Hospital (St Vincent's Private Hospital Northside)
627 Rode Road
Chermside. 4032
Brisbane. Qld.
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 305915 0
None
Name [1] 305915 0
Address [1] 305915 0
Country [1] 305915 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305823 0
Royal Brisbane Women's Hospital HREC
Ethics committee address [1] 305823 0
Royal Brisbane Women's Hospital HREC
Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 305823 0
Australia
Date submitted for ethics approval [1] 305823 0
01/05/2020
Approval date [1] 305823 0
Ethics approval number [1] 305823 0
Ethics committee name [2] 305824 0
St Vincent's Aged Care HREC
Ethics committee address [2] 305824 0
St Vincent's Private Hospital Northside
627 Rode Road
Chermside
QLD 4032
Ethics committee country [2] 305824 0
Australia
Date submitted for ethics approval [2] 305824 0
14/05/2020
Approval date [2] 305824 0
Ethics approval number [2] 305824 0
Ethics committee name [3] 305826 0
Wesley Hospital HREC
Ethics committee address [3] 305826 0
451 Coronation Drive
Auchenflower
QLD 4066
Ethics committee country [3] 305826 0
Australia
Date submitted for ethics approval [3] 305826 0
25/05/2020
Approval date [3] 305826 0
Ethics approval number [3] 305826 0

Summary
Brief summary

The purpose of this study is to determine if a commonly used radiological solution (Gastrografin) is a suitable option to help with the detection of anastomotic leakage, a serious complication of intestinal surgery.

Who is it for?
You may be eligible for this study if you are an adult who is undergoing rectal resection and extra-peritoneal anastomosis without a diverting loop ileostomy.

Study details
All participants will undergo their rectal resection as per usual. In the 5 days following the resection, participants will undergo a rectal tube flushing 4 times a day with saline containing Gastrografin. Rectal tube is routinely flushed with saline 4 times per day as part of standard care.
A drain fluid sample will be collected twice per day following the flushing of rectal tube with Gastrografin. Two rectal tube specimens will be also be collected, Routine blood tests, that are already performed for usual post operative care, will be recorded.

The findings from this study are hoped to provide early evidence of anastomotic leakage and permit clinicians the opportunity to treat patients before they deteriorate. This will lead to better outcomes for patients and a cost saving to health systems.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101722 0
A/Prof David Clark
Address 101722 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside. 4032
Brisbane. Qld.
AUSTRALIA
Country 101722 0
Australia
Phone 101722 0
+61 07 33502088
Fax 101722 0
+61 7 3350 2333
Email 101722 0
david.clark@doctors.org.uk
Contact person for public queries
Name 101723 0
A/Prof David Clark
Address 101723 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside. 4032
Brisbane. Qld.
AUSTRALIA
Country 101723 0
Australia
Phone 101723 0
+61 07 33502088
Fax 101723 0
+61 7 3350 2333
Email 101723 0
david.clark@doctors.org.uk
Contact person for scientific queries
Name 101724 0
A/Prof David Clark
Address 101724 0
St Vincent’s Private Hospital Northside
627 Rode Road
Chermside. 4032
Brisbane. Qld.
AUSTRALIA
Country 101724 0
Australia
Phone 101724 0
+61 07 33502088
Fax 101724 0
+61 7 3350 2333
Email 101724 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
HREC policy prevents participant data sharing
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7684 0
Informed consent form
Citation [1] 7684 0
Link [1] 7684 0
Email [1] 7684 0
david.clark@doctors.org.uk
Other [1] 7684 0
Attachment [1] 7684 0
Summary results
No Results