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
A/Prof David Clark
60 participants
Aug 18, 2020
Interventional
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria4
- Age less than 18 years
- Inability to give written consent
- Proctocolectomy and ileal pouch surgery
- Allergy to iodine
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Interventions
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.
Locations(4)
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ACTRN12620000710921