Clinical trial NCT01565993: The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps
Official title: Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postpolypectomy Bleeding
Lead sponsor: Hospital Severo Ochoa
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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-)

Eligibility criteria: 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.

Primary outcomes:
measure: The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)
timeFrame: 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:
measure: Difficult to Place the Clip
timeFrame: During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)
Other outcomes:
Locations:
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
Study officials:
affiliation: Hospital Universitario Severo Ochoa
name: Elvira M Quintanilla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Severo Ochoa
name: Luis R Rábago, PhD
role: STUDY_DIRECTOR
References:
citation: Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Oct;2(4):183-188. doi: 10.4161/jig.23741. Epub 2012 Oct 1.
citation: Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Apr;2(2):99-104. doi: 10.4161/jig.22210. Epub 2012 Apr 1.