Adenomatous Polyp of Colon, Colo-rectal Cancer, Polyp of Colon
Conditions
Brief summary
The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps \<=3mm during colonoscopy.
Detailed description
The details of the proposed study are as follows: 1. Experimental group: using cold forceps for polyps \<=3mm of the colon 2. Control group: using cold snare for polyps \<=3mm of the colon 3. Methods: 1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place. 2. If polyps \<=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare. 3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion. 4. The polyp as well as well as the two biopsies are reviewed by a pathologist.
Interventions
PROCEDURECold forcep polypectomy
Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
PROCEDURECold snare polypectomy
Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients 18 years or older * Polyps \<=3mm
Exclusion criteria
* Pregnant * Inflammatory bowel disease * Polyposis syndromes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completeness of resection | 2 weeks | The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to resection | During the procedure | The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared. |
| Number of forcep bites or snare attempts | During the procedure | We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment. |
| Complications | 4 weeks | We will compare rates of complications including perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality. |
Countries
United States
Outcome results
None listed