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A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery
This study compare and analyze the efficiency of endoscopic ultrasound guided colorectal ESD surgery with traditional colorectal ESD surgery, in order to guide colorectal ESD operations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the endoscopic ultrasound guided colorectal ESD surgery group | Experimental | The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. Then undergo the colorectal ESD surgery. |
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| the traditional colorectal ESD surgery group | Active Comparator | the traditional colorectal ESD surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ultrasound guided colorectal ESD surgery | Procedure | The experimental group first underwent endoscopic ultrasound examination, with a small ultrasound probe inserted into the intestinal cavity through the biopsy port. After water injection, the lesion was scanned and (1) the direction of gravity was determined. (2) fibrosis/infiltration under the mucosa, and the fibrosis was divided into F0 (no fibrosis), F1 (cold fibrosis), or F2 (severe fibrosis). (3) The lesion was divided into nine compartments. Mark submucosal fibrosis/infiltration sites, according to nine compartments. (4) Based on the results of endoscopic ultrasound scanning of the lesion, the surgeon draw up surgical approach and perform injection and dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| operating time | from the injection to the end of dissection （minutes） | During surgery |
| Measure the area of the lesion | Measure the length and diameter of the lesion | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of propria muscle layer injuries during surgery | record the points of propria muscle layer injuries during surgery | During surgery |
| Time to first fluid diet | Postoperative recovery: record the first time of fluid diet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Xu, professor | Contact | 18844097668 | 18844097668@163.com | |
| Dong Yang, doctor | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Jilin University | Recruiting | Changchun | Jilin | 130021 | China |
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| the traditional colorectal ESD surgery | Procedure | The control group underwent injection and dissection directly. |
|
| one week after surgery |
| Complete resection rate | record the number of complete resection cases | 1 year |