Colorectal Polyps
Conditions
Brief summary
This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.
Interventions
PROCEDUREcold snare polypectomy
Cold snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.
PROCEDUREhot snare polypectomy
Hot snare polypectomy was conducted for the removal of 4-10 mm pedunculated colorectal polyps.
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years old, male and female 2. Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp
Exclusion criteria
1. Contraindication to colonoscopy or polypectomy 2. Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy 3. Alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma 4. Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding 5. Inadequate bowel preparation 6. Pregnant or lactating women 7. Failure to sign the informed consent form 8. Patients deemed ineligible by investigators to enrol in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delayed postoperative bleeding | interviewed by telephone on days 2 and 14 after polypectomy | bleeding that developed within 2 weeks after the patient left the endoscopy unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immediate postpolypectomy bleeding | during the polypectomy | Blood spray or persistent oozing for more than 60 seconds requiring endoscopic intervention |
| procedure time | during the polypectomy | The duration from the appearance of the snare on the monitor to the time when the endoscope was withdrawn from the lesion |
| perforation rate | during the polypectomy, and interviewed by telephone on days 2 and 14 after polypectomy | Proportion of patients with intraoperative or postoperative perforation |
| complete histologic resection | during the polypectomy | Clear resection margins, no polyp involvement |
| use of haemostatic clips | during the polypectomy | — |
| en bloc resection | during the polypectomy | Removal of a polyp with a single cut and was assessed by the colonoscopist |
Countries
China
Contacts
Primary ContactYanqing Li
Outcome results
None listed