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Patients scheduled for an endoscopic submucosal dissection(ESD) in the colorectum will be randomized to the use of a traction device(consisting of an endoscopic clip with a loop of dental floss secured in the lesion to be removed, another clip will anchor the loop to adjacent bowel wall) or a standard ESD.
Patients with an adenoma or an early colorectal cancer treatable with endoscopic submucosal dissection will be randomized to the use of a traction device or a standard ESD. Location, morphology and size of the lesion will be recorded. Time of the procedure will be measured using a stopwatch
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | Standard endoscopic submucosal dissection | |
| Interventional | Active Comparator | Mandatory use of the clip-traction device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clip-traction | Device | A endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier. |
| Measure | Description | Time Frame |
|---|---|---|
| Resection speed (mm2/min) | Measured as area of the removed lesion divided by procedure time. | Within completion of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Marsk, MD,PhD | Contact | +46812358108 | richard.marsk@ki.se | |
| Björn Törnqvist, MD,PhD | Contact | +46812358477 | bjorn.tornqvist@sll.se |
| Name | Affiliation | Role |
|---|---|---|
| Richard Marsk, MD,PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoskopicentrum Danderyds Sjukhus | Recruiting | Stockholm | 18288 | Sweden |
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