Colorectal endoscopic mucosal resection (a procedure to remove precancerous, early-stage cancer or other abnormal tissues from the digestive tract) and reducing delayed bleeding in high risk patients
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ABSTRACT: Background and study aims
Delayed bleeding (bleeding from the bowel occurring more than 24 hours following endoscopic removal of polyps) is the most common complication following Endoscopic Mucosal Resection (EMR), occurring in up to 12% of cases depending on various risk factors. To date, there are no established guidelines to lessen this risk, with various studies of different treatment options showing some inconsistent and sometimes conflicting results. PuraStat® is a licenced product that can be applied through the endoscope directly following polyp removal to form a gel coat over the area where the polyp was removed. This product is already in use in UK hospitals in endoscopy procedures and has been proven to be completely safe.
The aim of the study is to collect data to help us understand whether applying PuraStat® after a colorectal polyp is removed can reduce the risk of delayed bleeding for a period of 30 days following EMR, compared to not using PuraStat® (standard practice).
Who can participate?
Patients undergoing EMR of colorectal polyps, and with high risk of delayed bleeding.
What does the study involve?
Patients with high delayed bleeding risk referred for EMR of colorectal polyps of 20mm or more in size will be randomised to receive either prophylactic application of PuraStat® to the EMR base (treatment group) or standard treatment (no PuraStat®, control group).
DISEASE(S): Colorectal Polyps
PROVIDER: 48369 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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