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Cold versus hot snare polypectomy in post polypectomy bleeding in small colonic polyps
ISRCTN ISRCTN91553378
ClinicalTrials.gov identifier
Public title Cold versus hot snare polypectomy in post polypectomy bleeding in small colonic polyps
Scientific title A prospective, randomised comparison of cold versus hot snare polypectomy in the occurrence of post polypectomy bleeding in small colonic polyps
Acronym N/A
Serial number at source N/A
Study hypothesis The aim of our study is to compare cold snare polypectomy (CSP) with hot snare polypectomy (HSP) in the occurrence of postpolypectomy bleeding in small colonic polyps with size 3 - 8 mm.
Lay summary
Ethics approval Benizelion General Hospital Ethics Committee approved on the 17th December 2010 (ref: 16903)
Study design Randomised controlled trial
Countries of recruitment Greece
Disease/condition/study domain Colonic polyps
Participants - inclusion criteria 1. All patients founded with small polyps (3 - 8 mm) during colonoscopy
2. Cold snare group (CSP): male/female: 107/101 with age range: 59,4±13,6
3. Hot snare group (HSP): male/female: 125/81 with age range: 61,3±11,0
Participants - exclusion criteria 1. Cases with bleeding tendency (taking anticoagulant therapy, platelet count of less than 100,000/mm3, or prothrombin time more than 30% above the control
2. Cases with inadequate colonic preparation
3. Patients undergoing anticoagulant or antiplatelet therapy were instructed to discontinue the use of these types of medication at least 7 days before the endoscopic procedure
Anticipated start date 19/05/2010
Anticipated end date 13/10/2010
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 414
Interventions Colonoscopic polypectomy
Primary outcome measure(s) 1. Post polypectomy bleeding
2. All patients were contacted by telephone 12 hours, 2 days and 1 month after procedure and were asked about pain, abdominal tenderness, fever and bleeding
3. In the HSP group, small polyps were removed as a single piece with a standard electrosurgical snare (Sensation Polypectomy Snare 13mm, Microvasive, Boston Scientific, Natick, MA) and monopolar coagulation current, using a 120W OLYMPUS HF-120 generator with a setting of 72W in “endocut” function
4. In the CSP group, the polyp was removed as a single piece with the same electrosurgical snare. According to expert opinion[3] 1-to 2mm of normal tissue around the small polyp were ensnared in the CSP group. All colonoscopies were performed with wide-angle (170o), high-resolution videocolonoscopes – Olympus (CFH180AL, Tokyo, Japan) with a high-definition 1080-line screen - Olympus (OEV191H, Tokyo, Japan) and video processor Olympus (EVIS EXERA II CV-180, Tokyo, Japan).
5. Bowel preparation was accomplished with a 4L electrolyte solution of polyethylene glycol.
Secondary outcome measure(s) All patients were contacted by telephone 12 hours, 2 days and 1 month after procedure and were asked about:
1. Pain
2. Abdominal tenderness
3. Fever
4. Bleeding
Sources of funding Benizelion General Hospital (Greece)
Trial website
Publications
Contact name Dr  Gregorios  Paspatis
  Address Benizelion General Hospital
Gastroenterology Department
Knossou Avenue
  City/town Heraklion, Crete
  Zip/Postcode 71409
  Country Greece
  Email paspati@admin.teiher.gr
Sponsor Benizelion General Hospital (Greece)
  Address Knossou Avenue
  City/town Heraklion
  Zip/Postcode 71409
  Country Greece
  Email paspati@admin.teiher.gr
Date applied 26/12/2010
Last edited 06/05/2011
Date ISRCTN assigned 06/05/2011