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

Not Applicable

Terminated

• Conditions: Postpolypectomy Bleeding
• Interventions: Device: Hemoclip; Device: Conventional Polipectomy

• Registration Number: NCT01565993
• Lead Sponsor: Hospital Severo Ochoa

Brief 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

Detailed 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-)

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Results First Submitted: 2012-03-28
• Study First Posted: 2012-03-29
• Status Verified: 2012-04
• Results First Submitted QC: 2012-04-25
• Last Update Submitted: 2012-04-25
• Results First Posted: 2012-05-25
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemoclip	Hemoclip	In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
Conventional Polipectomy	Conventional Polipectomy	In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique

Primary Outcome Measures

Name	Time	Method
The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)	Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding	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

Secondary Outcome Measures

Name	Time	Method
Difficult to Place the Clip	During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)	The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.

Trial Locations

Locations (1)

Hospital Universitario Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain