- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02208401
Randomised Comparison of 2 Cold Snare Polypectomy Techniques
August 12, 2014 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S5 7AU
- Sheffield Teaching Hospitals NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: conventional cold snare polypectomy
|
conventional cold snare polypectomy
|
Experimental: Cold snare polypectomy with suction
|
Cold snare polypectomy with suction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete macroscopic polyp eradication rate
Time Frame: At time of polypectomy intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shawinder Johal, MBChB, PhD, MRCP, Sheffield Teaching Hospitals NHS Foundation Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
July 30, 2014
First Submitted That Met QC Criteria
August 4, 2014
First Posted (Estimate)
August 5, 2014
Study Record Updates
Last Update Posted (Estimate)
August 13, 2014
Last Update Submitted That Met QC Criteria
August 12, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- STH17227
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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