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Randomised Comparison of 2 Cold Snare Polypectomy Techniques

NCT02208401 — Not applicable, Completed, 112 participants, Sheffield Teaching Hospitals NHS Foundation Trust

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A Prospective Randomised Comparison of Cold Snare Polypectomy Versus Cold Snare Pseudosuction Technique

RegistryNCT02208401
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment112 (Actual)
SponsorSheffield Teaching Hospitals NHS Foundation Trust (Other)
ConditionsBowel Cancer
Interventionsconventional cold snare polypectomy, Cold snare polypectomy with suction (Procedure)
Datesstart 2014-01-01, primary completion 2014-08-01, completion 2014-08-01, first posted 2014-08-05, last updated 2014-08-13
Locations1 site in United Kingdom

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
conventional cold snare polypectomyActive comparatorProcedure: conventional cold snare polypectomyconventional cold snare polypectomy
Cold snare polypectomy with suctionExperimentalProcedure: Cold snare polypectomy with suctionCold snare polypectomy with suction
  • conventional cold snare polypectomy (Procedure): conventional cold snare polypectomy
  • Cold snare polypectomy with suction (Procedure): Cold snare polypectomy with suction

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Sheffield Teaching Hospitals NHS Foundation TrustSheffield, South YorkshireUnited Kingdom

+Publications

  • Results publication: 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

+Investigators

My Notes