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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05250518
Other study ID # WDRY2022-K018
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2022
Est. completion date October 2023

Study information

Verified date February 2022
Source Renmin Hospital of Wuhan University
Contact Mingkai Chen, Ph.D & M.D
Phone +86 13720330580
Email chenmingkai@whu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1017
Est. completion date October 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. age>18 years 2. the diagnosis of colorectal polyps is clear(Paris Ip or ?sp) 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 ? 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
argon 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.
clip 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.

Locations

Country Name City State
China Renmin Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of re-bleeding the rate of re-bleeding within 30 days after operation 30 days after HSP
Secondary Location of re-bleeding sites the original polyps' location of re-bleeding sites: cecum, ascending colon, colonic hepatic flexure, transverse colon, colonic splenic flexure , descending colon, sigmoid colon, rectum 30 days after HSP
Secondary Other postoperative complications Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.) 30 days after HSP
Secondary Expenses of prevention Expenses of argon plasma coagulation and clips the 1 day of discharge from medical centers
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