Colo-rectal Cancer Clinical Trial
Official title:
Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.
Verified date | May 2022 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 181 |
Est. completion date | November 20, 2021 |
Est. primary completion date | October 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years or older - Polyps <=3mm Exclusion Criteria: - Pregnant - Inflammatory bowel disease - Polyposis syndromes |
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Palo Alto Health Care System | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completeness of resection | The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups. | 2 weeks | |
Secondary | Time to resection | The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared. | During the procedure | |
Secondary | Number of forcep bites or snare attempts | We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment. | During the procedure | |
Secondary | Complications | 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. | 4 weeks |
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