Bowel Cancer Clinical Trial
Official title:
A Prospective Randomised Comparison of Cold Snare Polypectomy Versus Cold Snare Pseudosuction Technique
Different modalities are employed to remove small colonic polyps which potentially harbour a cancer risk. But, they can all vary in their completeness of removal, safety and the histological quality and the gold standard technique has yet to be defined. A novel suction pseudopolyp technique has been described by Patullo et al and in their prospective study, 126 polyps measuring less than 10mm flat or sessile were removed by this method with 100% complete endoscopic resection and without any immediate or delayed complications. The aim of the investigators study is to compare this technique with the standard cold snare technique. Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size will be eligible and they will be randomised to the polypectomy technique. Patient demographics and polyp characteristics will be recorded. The primary outcome measured will be the macroscopic resection rate. The secondary outcome measures are abdominal pain, tenderness, bleeding and fever.
Status | Completed |
Enrollment | 112 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients with small polyps 3-7 mm in size, flat or sessile found during colonoscopy Exclusion Criteria: - Patients are less than 18 years old - Pregnant - Inadequate bowel preparation - On anticoagulants or clopidogrel |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Complete macroscopic polyp eradication rate | The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data. | At time of polypectomy intervention | No |
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