Bleeding, Colonic Polyps, Colon Nos Polypectomy Tubular Adenoma, Complications, Polyp of Large Intestine
Conditions
Keywords
diminutive polyps, small polyps, cold snare polypectomy, complications, bleeding
Brief summary
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.
Interventions
DEVICEExacto™
Cold snare polypectomy
Sponsors
San Gerardo Hospital
Azienda Ospedaliero Universitaria Maggiore della Carita
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All consecutive patients undergoing colonoscopy, with at least one and no more than 5 polyps \<10 mm. * The patient is at satisfactory risk to undergo abdominal surgery. * The patient must understand and provide written consent for the procedure.
Exclusion criteria
* Patients with inflammatory bowel disease. * Patients undergoing standard snare resection (with cautery) of polyps larger than 10 mm. * Patients with a personal history of polyposis syndrome. * Patients with suspected chronic stricture potentially precluding complete colonoscopy. * Patients with diverticulitis or toxic megacolon. * Patients with a history of radiation therapy to abdomen or pelvis. * Patients with a history of severe cardiovascular, pulmonary, liver or renal disease. * Personal history of coagulation disorders or use of anticoagulants/clopidogrel/aspirin/ticlopidine. * Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of complete polyp removal | One year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success according to size | One year | Clinical success (as defined in the primary end-point) according to the size class: diminutive (\<5 mm) and small (6-9 mm) polyps. |
| Post-polypectomy bleeding rates | One year | 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. |
Countries
Italy
Outcome results
None listed