Haemostatic Gel Prophylaxis for Post Colorectal Endoscopic Resection Bleeding: Observational Study

Interventions: Advanced endoscopic resection techniques such as Endoscopic Mucosal Resection (EMR) have provided a minimally invasive alternative to surgery for curative management of advanced mucosal neoplasia. The safety profile and outcomes of EMR techniques are significantly better than surgical resection however significant post resection bleeding remains an ongoing challenge. There is currently no consistently recommended strategy to reduce the risk of post-EMR bleeding that has been adopted as standard of care. In particular, patients on antithrombotic therapy are at high risk of post procedure bleeding and strategies to mitigate this are required.
A recently introduced haemostatic gel (Purastat, 3D-Matrix) that acts as a self assembling nanoparticle matrix has demonstrated efficacy as a topical haemostat in controlling oozing bleeding in a number of anatomical locations including applications in ENT, Gynaecology, and endoscopy.
The haemostatic gel will be applied to the post EMR mucosal defect to consecutive eligible, consenting patients undergoing endoscopic mucosal resection who are on anti-thrombotic therapy (excluding single agent aspirin) or multiple agents. We will be applying aliquots of 1-5mLs of the gel matrix; the exact amount will be determined by the size of the defect remaining post excision of the target lesion. Gel will be applied endoscopically at the time of the procedure via the proceduralist until the entire defect has been covered - this is considered the one and only time the gel will be delivered.
Primary outcome(s): Rate of clinically significant post-procedural bleeding requiring further intervention (such as blood transfusion, admission to hospital, or other blood products (such as platelets, fresh frozen plasma, prothrombinex)
This will be assessed clinically by the presence of gastrointestinal bleeding (such as per-rectal bleeding) where patients were given blood products as documented in the medical record.[30 days post endoscopic procedure]
Study Design: Purpose: Prevention; Allocation: Non-randomised trial