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

ABSTRACT: 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. Primary outcome(s): Level of Gastrografin in drain fluid will be measured by DECT and ICP-MS[Day 1, 2, 3, 4, 5 or until rectal tube is in situ];Anastomotic leak after surgery by clinical assessment and CT (as per standard care)[Day 1, 2, 3, 4, 5 post surgery] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial

DISEASE(S): Surgery-other Surgery,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Anterior Rectal Resection

PROVIDER: 2470927 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR