Condition category
Digestive System
Date applied
26/12/2010
Date assigned
06/05/2011
Last edited
06/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gregorios Paspatis

ORCID ID

Contact details

Benizelion General Hospital
Gastroenterology Department
Knossou Avenue
Heraklion
Crete
71409
Greece
paspati@admin.teiher.gr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A prospective, randomised comparison of cold versus hot snare polypectomy in the occurrence of post polypectomy bleeding in small colonic polyps

Acronym

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.

Ethics approval

Benizelion General Hospital Ethics Committee approved on the 17th December 2010 (ref: 16903)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colonic polyps

Intervention

Colonoscopic polypectomy

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

19/05/2010

Overall trial end date

13/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

414

Participant 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

Recruitment start date

19/05/2010

Recruitment end date

13/10/2010

Locations

Countries of recruitment

Greece

Trial participating centre

Benizelion General Hospital
Heraklion, Crete
71409
Greece

Sponsor information

Organisation

Benizelion General Hospital (Greece)

Sponsor details

Knossou Avenue
Heraklion
71409
Greece
paspati@admin.teiher.gr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Benizelion General Hospital (Greece)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes