Large colorectal polyps
Conditions
Interventions
Colon
Recurrence
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients referred for endoscopic removal of a large sessile colonic polyp sized bigger or are 20mm Age >18 years Able to give informed consent to involvement in trial
Exclusion criteria
Exclusion criteria: -Lesion involving the ileocaecal valve -Pregnancy: currently pregnant or attempting to become pregnant -Lactation: currently breastfeeding -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 -Known with or the endoscopic suspicion of the presence of hereditary polyposis, such as FAP, Lynch syndrome and serrated polyposis syndrome or bowel cancer syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the presence of residual/recurrence of polyp tissue at or immediately surrounding the previous EMR site at follow up colonoscopic procedures (at 18 months and 36 months) after WF-EMR involving the SCAR technique of either SERT 0 lesions or SERT 1-4 lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are the following: • Lesion characteristics and procedural characteristics of the initial EMR data of SERT 0 and SERT 1-4, such as - Location of the lesion - Rate of *en bloc resection* (removing entire lesion in one snare) with histologically confirmed clear margins - The number of snare resections needed to achieve complete clearance - Number of injections required for haemostasis - Location of bleeding vessels - Size/number of bleeding vessels - Time required for EMR - Frequency of adverse events, bleeding, perforation or readmission - Need for surgery - Evidence of malignancy • The presence of residual/recurrence of polyp tissue at or immediately surrounding the previous EMR site at follow up colonoscopic procedures at 6 months after WF-EMR involving the SCAR technique of SERT 1-4 lesions. . • Histology and dysplasia of the residual/recurrence at or immediately surrounding the previous EMR site detected at all follow up colonoscopic procedures • The frequency of malignant submucosal invasive disease present within the residual/recurrence of polyp tissue at or immediately surrounding the previous EMR site • The frequency of the necessity to perform an additional surgical resection due the impossibility to endoscopically resect residual/recurrence of polyp tissue or due to malignant submucosal invasive disease at or immediately surrounding the previous EMR site | — |
Countries
The Netherlands
Outcome results
None listed