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Patients will be randomised to have endoscopic clips applied to the Endoscopic Mucosal Resection (EMR) site following complete removal of the lesion, or will not receive clips and proceed with standard of care.
The outlined literature suggests that colonic post EMR bleeding may be prevented by the use of prophylactic endoscopic clips. There has thus far been no prospective study to confirm this concept. The ideal way to prove the hypothesis is to conduct a randomised controlled trial to evaluated the use of prophylactic clip placement on the EMR resection defect, for the purpose of preventing delayed bleeding in colonic wide field EMR (lesions>20mm). Given the significantly increased rate of bleeding in the proximal colon, clip placement in this location may have the greatest benefit. If it is proven that such a prophylactic technique is effective and safe, it may lead to significantly decreased patient morbidity and health care resources associated with the management delayed bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Clipping | Experimental | Participants randomised to the arm will receive endoscopic clips to their defect following EMR. |
|
| No Endoscopic Clipping | No Intervention | These participants will receive standard of care practice only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Clip | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Procedural Bleeding | Clinically significant post colonic wide-field EMR bleeding (CSPEB) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety success | Safety - admission rates, adverse outcomes, deaths Rate of initial technical success Duration of procedure Recurrence rate | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Bourke, MBBS | Western Sydney Local Health District | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Endoscopy Unit | Westmead | New South Wales | 2145 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34801133 | Derived | Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF, Zahid S, Whitfield A, Byth K, Brown G, Lee EYT, Williams SJ, Burgess NG, Bourke MJ. Effect of prophylactic endoscopic clip placement on clinically significant post-endoscopic mucosal resection bleeding in the right colon: a single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):152-160. doi: 10.1016/S2468-1253(21)00384-8. Epub 2021 Nov 18. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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