Randomised Comparison of 2 Cold Snare Polypectomy Techniques

Not Applicable

Completed

• Conditions: Bowel Cancer
• Interventions: Procedure: Cold snare polypectomy with suction; Procedure: conventional cold snare polypectomy

• Registration Number: NCT02208401
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-30
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold snare polypectomy with suction	Cold snare polypectomy with suction	Cold snare polypectomy with suction
conventional cold snare polypectomy	conventional cold snare polypectomy	conventional cold snare polypectomy

Primary Outcome Measures

Name	Time	Method
Complete macroscopic polyp eradication rate	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.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom