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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the control group | No Intervention | The control group will receive no prophylaxis of post-procedure bleeding. | |
| APC group | Experimental | The APC group will receive prophylaxis of post-procedure bleeding with argon plasma coagulation. |
|
| Clip group | Experimental | The Clip group will receive prophylaxis of post-procedure bleeding with clip closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| argon plasma coagulation | Procedure | After hot snare polypectomy, participants will be randomized assigned to the APC group for argon plasma coagulation to prevent colorectal post-procedure bleeding. |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of re-bleeding | the rate of re-bleeding within 30 days after operation | 30 days after HSP |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Other postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingkai Chen, Ph.D & M.D | Contact | +86 13720330580 | chenmingkai@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Mingkai Chen, Ph.D & M.D | Renmin Hospital of Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
undecided
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| ID | Term |
|---|---|
| D057908 | Argon Plasma Coagulation |
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D002425 | Cautery |
| D013812 | Therapeutics |
| D006489 | Hemostatic Techniques |
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| clip closure | Procedure | 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. |
|
Other postoperative complications (perforation, electrocoagulation syndrome after polypectomy, stenosis, etc.) |
| 30 days after HSP |
| Expenses of prevention | Expenses of argon plasma coagulation and clips | the 1 day of discharge from medical centers |
| D055011 |
| Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D006488 | Hemostasis, Surgical |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |