Cold versus hot snare polypectomy in post polypectomy bleeding in small colonic polyps
| ISRCTN | ISRCTN91553378 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91553378 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/12/2010
- Registration date
- 06/05/2011
- Last edited
- 06/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gregorios Paspatis
Scientific
Scientific
Benizelion General Hospital
Gastroenterology Department
Knossou Avenue
Heraklion, Crete
71409
Greece
| paspati@admin.teiher.gr |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective, randomised comparison of cold versus hot snare polypectomy in the occurrence of post polypectomy bleeding in small colonic polyps |
| Study objectives | 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(s) | Benizelion General Hospital Ethics Committee approved on the 17th December 2010 (ref: 16903) |
| Health condition(s) or problem(s) studied | Colonic polyps |
| Intervention | Colonoscopic polypectomy |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 19/05/2010 |
| Completion date | 13/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 414 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/05/2010 |
| Date of final enrolment | 13/10/2010 |
Locations
Countries of recruitment
- Greece
Study participating centre
Benizelion General Hospital
Heraklion, Crete
71409
Greece
71409
Greece
Sponsor information
Benizelion General Hospital (Greece)
Hospital/treatment centre
Hospital/treatment centre
Knossou Avenue
Heraklion
71409
Greece
| paspati@admin.teiher.gr | |
"ROR" |
https://ror.org/043889z90 |
Funders
Funder type
Hospital/treatment centre
Benizelion General Hospital (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
