Clinical Trial Details

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

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Trial Information

Broad Health Condition Surgery
Cancer

Specific Health ConditionOther surgery
Bowel - Back passage (rectum) or large bowel (colon)

Trial FocusDiagnosis

Recruitment statusRecruiting

Recruitment Details
Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston
Holy Spirit Northside - Chermside
The Wesley Hospital - Auchenflower
St Andrew's War Memorial Hospital - Brisbane


Postcode
4029 - Royal Brisbane Hospital
4032 - Chermside
4029 - Herston
4066 - Auchenflower
4000 - Brisbane

Anticipated date of first participant enrolment30/06/2020

Anticipated date of last participant enrolment30/06/2020

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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.



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 age18 Years

GenderBoth 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
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: A/Prof David Clark
Primary Sponsor Address: Holy Spirit Northside Private Hospital (St Vincent's Private Hospital Northside) 627 Rode Road Chermside. 4032 Brisbane. Qld. AUSTRALIA
Primary Sponsor Country: Australia

Trial IDACTRN12620000710921

Contact person for information and recruitmentA/Prof
David Clark
St Vincent’s Private Hospital Northside 627 Rode Road Chermside. 4032 Brisbane. Qld. AUSTRALIA
+61 07 33502088
+61 7 3350 2333
Further information icondavid.clark@doctors.org.uk
Australia