None listed
Conditions
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”.
Interventions
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
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
Sponsors
Holy Spirit Northside Private Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
low or ultra-low anterior resection no covering loop ileostomy
Exclusion criteria
covering loop ileostomy allergy to Gastrografin (Iodine)
Outcome results
None listed