Study hypothesis
The aim of this study is to evaluate whether intraoperative fluorescence angiography (IFA) is able to decrease anastomotic leak (AL) rate in patients undergoing surgery for rectal cancer.
This study is led by Professor David Jayne from Leeds, with radiology led by Vicky Goh (Kings) and Damian Tolan (Leeds).
It will recruit 880 patients with rectal cancer planned for curative anterior resection, randomised 1:1 between surgery using IFA and surgery without IFA.
Primary Outcome
Clinical anastomotic leak rate, defined as per the International Study Group of Rectal Cancer definition as a confirmed defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments that has an impact on patient management, as assessed through clinical examination within 90 days post operation
Key secondary outcomes
1. Change in planned anastomosis during surgery, including the decision to undertake a permanent stoma rather than an anastomosis
2. Rate of defunctioning stoma (temporary or permanent)
3. Operative and post-operative complications within 90 days of operation
4. Length of post-operative hospital stay
5. Low Anterior Resection Syndrome (LARS) score at 30 days and at 90 days post-operation in patients without defunctioning ileostomy
6. Rate of re-interventions within 90 days
7. Quality of life
8. Health resource utilisation at 30 days and 90 days post-operation
9. Death within 90 days of operation
Mechanistic sub-study
1. Presence of vascular variants, presence of atherosclerosis within IMA
2. Presence of stenosis (≤or >50%) in the internal iliac artery, internal pudendal artery, superior rectal, middle rectal or inferior rectal artery
12. Difference in regional blood flow, blood volume or permeability surface area product in patient with or without anastomotic leak, no and prior (chemo)radiation, and intra-operative fluorescence
13. Changes in rectal microbiome and correlation to anastomotic leak
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