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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,017
After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding.
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.
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The rate of re-bleeding
the rate of re-bleeding within 30 days after operation
Time frame: 30 days after HSP
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
Time frame: 30 days after HSP
Other postoperative complications
Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.)
Time frame: 30 days after HSP
Expenses of prevention
Expenses of argon plasma coagulation and clips
Time frame: the 1 day of discharge from medical centers
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