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

Hospital Severo Ochoa

Status: Terminated

Conditions: Postpolypectomy Bleeding

Treatments: Device: Conventional Polipectomy; Device: Hemoclip

Study type: Interventional

Funder types: Other

Identifiers

NCT01565993

EQCLIPS

Details and patient eligibility

About

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

Full 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-)

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Hemoclip

Active Comparator group

Description:

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

Treatment:

Device: Hemoclip

Conventional Polipectomy

Active Comparator group

Description:

In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique

Treatment:

Device: Conventional Polipectomy