RecruitingACTRN12620000710921

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

Sponsor

A/Prof David Clark

Enrollment

60 participants

Start Date

Aug 18, 2020

Study Type

Interventional

Conditions

anterior rectal resection

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When surgeons perform bowel surgery involving a join (anastomosis) in the lower part of the colon or rectum, one of the most feared complications is a leak at the join site, called anastomotic leakage. This is a serious, potentially life-threatening complication that is often not detected until the patient becomes very unwell. Earlier detection could allow treatment to start sooner and prevent serious deterioration. This study is testing whether Gastrografin — a solution already commonly used in radiology — can be used as a tracer to detect anastomotic leaks earlier. After surgery, a small amount of Gastrografin is flushed through a rectal tube four times daily, and the drain fluid around the surgical site is analysed to see if the Gastrografin appears there (which would indicate a leak). You may be eligible if you are 18 or older and are undergoing a rectal resection (removal of part of the rectum) for either benign or cancer-related disease, where a join will be created and a drain and rectal tube will be placed. You must not be allergic to iodine, as Gastrografin contains iodine.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 stu

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)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Holy Spirit Northside - Chermside

QLD, Australia

The Wesley Hospital - Auchenflower

QLD, Australia

St Andrew's War Memorial Hospital - Brisbane

QLD, Australia

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ACTRN12620000710921