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| ID | Type | Description | Link |
|---|---|---|---|
| HREC2012/5/4.6 (3512) | Other Identifier | SydneyWAHS HREC - Westmead campus |
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Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) >= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Coagulation Arm | Active Comparator | Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect |
|
| Coagulation Arm | Experimental | Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Snare Tip Soft Coagulation | Other |
| ||
| No Snare Tip Soft Coagulation |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic recurrence | Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up | 4-6 months and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Histologic recurrence | Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar | 4-6 months and 18 months |
| En bloc resection | Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Bourke, FRACP, MBBS | Western SLHD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Endoscopy Unit | Westmead | New South Wales | 2145 | Australia | ||
| Princess Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30296436 | Derived | Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6. |
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| ID | Term |
|---|---|
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.
| Other |
|
| Index procedure |
| Snare resections | The number of snare resections needed to achieve complete clearance | Index procedure |
| Duration | Time required for EMR | Index procedure |
| Perforation during EMR | Perforation during EMR | During index procedure |
| Post EMR bleeding | Bleeding after EMR requiring admission or repeat intervention | Post Index procedure |
| Number of injections for hemostasis | Number of injections required for haemostasis | Index procedure, if post EMR bleeding |
| Location of bleeding vessels | Location of bleeding vessels | Index procedure, if post EMR bleeding |
| Size/number of bleeding vessels | Size/number of bleeding vessels | Index procedure, if post EMR bleeding |
| Delayed perforation | Delayed perforation requiring intervention or readmission | After index procedure |
| Readmission | Readmission after index procedure | After index procedure |
| Brisbane |
| Queensland |
| Australia |
| Lyell McEwin Hospital | Adelaide | South Australia | Australia |
| The Alfred Hospital | Melbourne | VA | Australia |