Randomised Comparison of 2 Cold Snare Polypectomy Techniques

NCT02208401 | Completed

• 1 other identifier: STH17227
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

conventional cold snare polypectomy

ACTIVE COMPARATOR

conventional cold snare polypectomy

Procedure: conventional cold snare polypectomy

Cold snare polypectomy with suction

EXPERIMENTAL

Cold snare polypectomy with suction

Procedure: Cold snare polypectomy with suction

Interventions

conventional cold snare polypectomy PROCEDURE

conventional cold snare polypectomy

conventional cold snare polypectomy

Cold snare polypectomy with suction PROCEDURE

Cold snare polypectomy with suction

Cold snare polypectomy with suction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with small polyps 3-7 mm in size, flat or sessile found during colonoscopy

You may not qualify if:

• Patients are less than 18 years old
• Pregnant
• Inadequate bowel preparation
• On anticoagulants or clopidogrel

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (1)

• Din S, Ball AJ, Riley SA, Kitsanta P, Johal S. A randomized comparison of cold snare polypectomy versus a suction pseudopolyp technique. Endoscopy. 2015 Nov;47(11):1005-10. doi: 10.1055/s-0034-1392533. Epub 2015 Jul 10.

  PMID: 26165735 DERIVED

MeSH Terms

Conditions

Intestinal Neoplasms

Interventions

Suction

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Shawinder Johal, MBChB, PhD, MRCP

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2014
• First Posted: August 5, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

GB (1)