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

Hospital Severo Ochoa108 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

108

Conditions

Postpolypectomy Bleeding

Interventions

HemoclipDEVICE

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 PolipectomyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding

Secondary Outcomes

Difficult to Place the Clip

The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.

Time frame: During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.