Efficacy and Safety Research of Cold Snare Polypectomy and Hot Snare Polypectomy in the Treatment of 4-9 mm Diameter Colorectal 0-Isp and 0-Ip Polyps: a Prospective, Multicenter, Randomized Controlled Study(FAST -REST Study)
Cold Snare ResectionHot Snare ResectionPolyps of Colon
Investigational drug(s) / intervention(s)
cold snare polypectomyhot snare polypectomy
cold snare polypectomy: Place the special cold snare in the normal mucosa 1-2mm away from the polyp edge. Tighten the snare at a constant speed and gently lift it up and then excision.
hot snare polypectomy: According to evaluation of the polyps, directly place the snare on the edge of the polyp including a clear margin of normal tissue (1-2 mm) or after submucosal injection. Tighten the snare at a constant speed and gently lift it up.Use the electrocoagulation and electroscission mode, power on for several seconds until the polyp is cut off.
Study summary
This study will evaluate the efficacy and safety of cold snare polypectomy(CSP) and hot snare polypectomy(HSP) in the treatment of colorectal 4-9mm 0-Isp and 0-Ip polyps, and compare the complete resection rate, postoperative late bleeding rate, intraoperative bleeding rate, en bloc resection rate, operation time and the number of metal clips used. The conclusion of this study will help clinical doctor develop more effective resection strategies for colorectal 0-Isp and 0-Ip polyps, and provide more effective treatment for patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age: 18-80 years old, male or female
2. At least one polyp with size of 4-9 mm 0-Isp or 0-Ip is found during colonoscopy
3. Voluntarily sign informed consent for endoscopic treatment
Exclusion Criteria:
1. Boston Bowel Preparation Scale\<6 points.
2. Patients who receive antiplatelet/anticoagulant therapy within 5 days before polypectomy.
3. Participants with a contraindication to colonoscopy and polypectomy.
4. Patients with inflammatory bowel disease or gastrointestinal polyposis.
5. Lesions with submucosal invasion and those suspected of being cancerous at the preprocedural diagnostic evaluation.
6. Patients with pregnancy.
Primary outcome measure(s)
Complete resection rate — Up to 5-7 days from operation day The polyps and the two biopsies from the margin will be sent to the pathologist for further analysis. Two independent experienced pathologists will evaluate the samples separately and both are blinded to the technique performed for polypectomy. Complete resection rate is defined as the negative pathological evaluation of two biopsies obtained from the margin.
Trial sites (1)
Facility
City
Region
Status
Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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