Colorectal Polyps
Conditions
Keywords
Polypectomy, Cold biopsy forceps, Cold snare polypectomy, Diminutive colorectal polyp
Brief summary
European guidelines recommend the use of cold snare polypectomy (CSP) for removal of diminutive colorectal polyps (DCP)(5 mm or less). However, for DCP \< 4 mm cold biopsy forceps (CBF) may be optional. Moreover, CBF remains the endoscopist's technique of choice for polyp resection and CSP is associated with a failure of specimen retrieval for histology in up to 6.8% of cases. In this study, the investigators aimed to compare the efficacy of CSP with CBF for removal of DCP in routine colonoscopy
Interventions
PROCEDUREPolypectomy of diminutive colorectal polyps will be performed by CBF
All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CBF : The CBF will be performed using a standard biopsy forceps (Gluton Life ® Life Partners). Multiple biopsies bites were taken until complete resection (as many as needed).
PROCEDUREPolypectomy of diminutive colorectal polyps will be performed by CSP
All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CSP : The CSB procedure will be performed using a 9 mm cold snare (Exacto ® Life Partners). One to two mm of normal surrounding mucosa will be ensnared around the base of the polyp, followed by mechanical excision without electrocautery
Sponsors
Gabriel RAHMI
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Routine colonoscopy * Patient older than 18 years * at least one polyp measuring ≤ 5 mm
Exclusion criteria
* inflammatory bowel disease * polyposis syndrome, pregnancy * inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of the study is to compare CBF and CSP in terms of efficacy. The primary end-point is the rate of histological complete resection by anatomopathological examination. | through study completion, an average of 2 years. | Complete histological resection was defined as the absence of visualized residual polyp after saline irrigation as well as negative biopsies of the polypectomy site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specimen retrieval rate (% time of polypectomy) | through study completion, an average of 2 years. | specimen will be immediately suctioned into the operating channel. |
| Procedure time ( overall time between introduction and removal of colonoscope) | through study completion, an average of 2 years. | measure of the time until complete polyp resection is obtained |
| Procedure related adverse events will be collected (adverse events : %, number of event for each groupe) during the procedure or during the follow up period (28 days). | All patients will be followed-up until 28 days post-colonoscopy. | perforation, gastrointestinal and bleeding |
Countries
France
Outcome results
None listed