Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
304
At the end of the EMR procedure, the patient will be randomized. In the treated group, Nexpowder will be sprayed thanks to a catheter inserted through the operating channel of the endoscope.
Hopital Européen Georges Pompidou, 20 Rue Leblanc
Paris, France
Severe post-resection bleeding rate up to Day 30
Number of patients with a severe post-resection bleeding. It is defined as bleeding requiring a new endoscopy or surgery, OR a radiological embolization, OR blood transfusion, OR a re-hospitalization OR haematochezia with hemoglobin loss \> 2 g/dl
Time frame: 30 days
The success rate of Nexpowder application
Number of patients with a satisfactory covering of the scar by the powder
Time frame: Day of resection
Delayed perforation rate
Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner
Time frame: 30 days
Stenosis rate
Number of patients with the impossibility to pass through the lumen with a standard colonoscope
Time frame: 30 days
Post coagulation syndrome
Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner.
Time frame: 30 days
Bowel obstruction rate
Number of patients with at least one symptomatic bowel obstruction.
Time frame: 30 days
Rate of cases requiring transfusion related to post-EMR bleeding
Number of patients for whom at least one transfusion was ordered after the EMR
Time frame: 30 days
Rate and duration of hospitalizations
Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR
Time frame: 30 days
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