Colorectal Polyp, Post-polypectomy Bleeding
Conditions
Keywords
hot snare polypectomy, argon plasma coagulation, clip closure
Brief summary
Discuss the efficacy and safety of argon plasma coagulation （APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）; analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method.
Detailed description
This is a multicenter, randomized and controlled study. It aims to discuss the efficacy and safety of argon plasma coagulation（APC）in comparison with clip closure for preventing colorectal post-procedure bleeding（PPB） after hot snare polypectomy（HSP）, and analyze the risk factors and the cost-effectiveness of bleeding prophylaxis strategies with Decision Tree Analytical Method. According to the prophylaxis measures, patients enrolled in this study will be randomized into the control group, APC group and Clip group. It will collect participants' data of baseline character, postoperative and follow-up. All statistical analyses will be performed by SPSS 26.0 and Tree Age Pro 2011. Based on the previous studies, it is presumed that the rate of PPB for the control group, Clip group and APC group is 8%, 2% and 2%. Given two-side testing, an alpha of 0.05 and a power of 90%, allowing for a 5% dropout rate, the smallest sample size is 1287.
Interventions
PROCEDUREargon plasma coagulation
After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding.
PROCEDUREclip closure
After hot snare polypectomy, participants will be randomized assigned to the Clip group for complete closure(spacing between adjacent clips \< 1cm) to prevent colorectal post-procedure bleeding.
Sponsors
Renmin Hospital of Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age\>18 years 2. the diagnosis of colorectal polyps is clear（Paris Ip or Ⅰsp） 3. head diameter≥ 10 mm 4. HSP indications were met and no contraindications were found 5. patients (or the legal representative/guardian) with informed consent
Exclusion criteria
1. ASA Grade Ⅲ or above, or end-stage disease of major organs (such as malignancy, heart failure, chronic obstructive pulmonary disease, end-stage renal disease and so on) 2. coagulation dysfunction (INR ≥ 1.5, PLT \< 50×10 \^9 / L) 3. use antiplatelet drugs within 7 days before the operation, anticoagulant drugs within 5 days, and/or blood products within 30 days after the operation 4. there were other lesions in the resection site of the included polyps affecting this study, or the intestinal preparation was insufficient 5. incomplete closure of clips (complete closure: spacing between adjacent clips \< 1cm) 6. APC is used for polypectomy or intraoperative hemostasis, rather than preventing PPB 7. surgical treatment, vascular intervention, or blood products were used during the operation 8. use other methods to prevent PPB 9. the bleeding site was not confirmed by endoscopy 10. history of intestinal surgery 11. menstruation or pregnancy 12. not following medical advice 13. participated in other clinical trials and signed its informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of re-bleeding | 30 days after HSP | the rate of re-bleeding within 30 days after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Location of re-bleeding sites | 30 days after HSP | the original polyps' location of re-bleeding sites: cecum, ascending colon, colonic hepatic flexure, transverse colon, colonic splenic flexure , descending colon, sigmoid colon, rectum |
| Other postoperative complications | 30 days after HSP | Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.) |
| Expenses of prevention | the 1 day of discharge from medical centers | Expenses of argon plasma coagulation and clips |
Countries
China
Contacts
Primary ContactMingkai Chen, Ph.D & M.D
Outcome results
None listed