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Comparison of Argon Plasma Coagulation and Clip Closure for the Prophylaxis of Colorectal Post-polypectomy Bleeding After Hot Snare Polypectomy: a Multicenter, Randomized and Controlled Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Start Date
March 1, 2022
Primary Completion Date
August 1, 2023
Completion Date
October 1, 2023
Last Updated
February 22, 2022
1,017
ESTIMATED participants
argon plasma coagulation
PROCEDURE
clip closure
PROCEDURE
Lead Sponsor
Renmin Hospital of Wuhan University
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07114380