Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality. Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant. Most of the polypectomies are performed for diminutive (\<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps. To minimize the risk of complications when removing \<10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed. Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials. Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy. The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Cold snare polypectomy
Endoscopy Unit, Gastroenterology Department, Humanitas Research Hospital
Rozzano, Milan, Italy, Italy
San Gerardo Hospital
Monza, Italy
Azienda Ospedaliera "Maggiore della Carità"
Novara, Italy
Percentage of complete polyp removal
Clinical success, defined as absence of polyp tissue, either hyperplastic or adenomatous, on the margins of the polypectomy area after cold-polypectomy of subcentimetric polyps. Such assessment is performed on two biopsies performed on the polypectomy scar. The investigators will calculate the percentage (%) of complete and incomplete polypectomies with the new device.
Time frame: One year
Clinical success according to size
Clinical success (as defined in the primary end-point) according to the size class: diminutive (\<5 mm) and small (6-9 mm) polyps.
Time frame: One year
Post-polypectomy bleeding rates
Post-polypectomy bleeding defined as any bleeding requiring immediate therapeutic endoscopic procedure (i.e. clipping, electrocautery) or delayed treatment, such as hospitalization or new endoscopic procedure.
Time frame: One year
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