Colorectal Endoscopic Submucosal Dissection(ESD) Surgery
Conditions
Keywords
colorectal, Endoscopic submucosal dissection, ultrasound
Brief summary
A prospective randomized controlled study protocol between endoscopic ultrasound guided colorectal ESD and traditional colorectal ESD surgery
Detailed description
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.
Interventions
PROCEDUREendoscopic ultrasound guided colorectal ESD surgery
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.
PROCEDUREthe traditional colorectal ESD surgery
The control group underwent injection and dissection directly.
Sponsors
Jilin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cases in our hospital who require colorectal ESD surgery * Colorectal lesions（laterally spreading tumor）.
Exclusion criteria
* Laterally spreading tumor but not nodular mixed type(LST-G-M) * Patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operating time | During surgery | from the injection to the end of dissection （minutes） |
| Measure the area of the lesion | During surgery | Measure the length and diameter of the lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of propria muscle layer injuries during surgery | During surgery | record the points of propria muscle layer injuries during surgery |
| Time to first fluid diet | one week after surgery | Postoperative recovery: record the first time of fluid diet |
| Complete resection rate | 1 year | record the number of complete resection cases |
Countries
China
Contacts
Primary ContactHong Xu, professor
Backup ContactDong Yang, doctor
Outcome results
None listed