The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps

Postpolypectomy Bleeding Clinical Trial

Official title:

Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01565993
• Other study ID #: EQCLIPS
• Status: Terminated
• Phase: N/A
• First received: March 27, 2012
• Last updated: April 25, 2012
• Start date: July 2007
• Est. completion date: August 2010

Study information

• Verified date: April 2012
• Source: Hospital Severo Ochoa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding

Description:

The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.

The aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen

• Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).

Exclusion Criteria:

• Patients younger than 18 years of age

• Patients with a platelet count of less than 50000, INR larger than 1.5

• Patients who refused to give their informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Postpolypectomy Bleeding

Intervention

Device:
• Hemoclip
A rotatable clip-fixing device "Quickclip 2" standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm
• Conventional Polipectomy
Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection

Locations

Country	Name	City	State
Spain	Hospital Universitario Severo Ochoa	Leganés	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Severo Ochoa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)	In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance	Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding	Yes
Secondary	Difficult to Place the Clip	The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.	During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)	Yes