Colonic Adenomas
Conditions
Keywords
snare tip soft coagulation, endoscopic mucosal resection, adenoma recurrence, adenoma, colonoscopy
Brief summary
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.
Interventions
OTHERNo Snare Tip Soft Coagulation
Sponsors
Professor Michael Bourke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Referred for removal of a colonic polyp \>= 20mm in size * Able to give informed consent to involvement in trial
Exclusion criteria
* Younger than 18 years of age * Highly dependant on medical care * Women who are pregnant or may be pregnant. * Taken clopidogrel within 7 days * Taken warfarin within 5 days * Had full therapeutic dose unfractionated heparin within 6 hours * Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours * Known clotting disorder * Previous attempt at EMR of the polyp referred for resection * Polyp located at the ileo-caecal valve, appendiceal orifice * Fully circumferential polyp * Incomplete snare resection of the polyp
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic recurrence | 4-6 months and 18 months | Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| En bloc resection | Index procedure | Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins |
| Snare resections | Index procedure | The number of snare resections needed to achieve complete clearance |
| Duration | Index procedure | Time required for EMR |
| Perforation during EMR | During index procedure | Perforation during EMR |
| Post EMR bleeding | Post Index procedure | Bleeding after EMR requiring admission or repeat intervention |
| Histologic recurrence | 4-6 months and 18 months | Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar |
| Location of bleeding vessels | Index procedure, if post EMR bleeding | Location of bleeding vessels |
| Size/number of bleeding vessels | Index procedure, if post EMR bleeding | Size/number of bleeding vessels |
| Delayed perforation | After index procedure | Delayed perforation requiring intervention or readmission |
| Readmission | After index procedure | Readmission after index procedure |
| Number of injections for hemostasis | Index procedure, if post EMR bleeding | Number of injections required for haemostasis |
Countries
Australia
Outcome results
None listed