Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps (NCT02245854) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps
Italy250 participantsStarted 2013-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.