The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps
This study has been terminated.
(The unexpected increase in morbidity of the hemoclip group)
Sponsor:
Hospital Severo Ochoa
Information provided by (Responsible Party):
Elvira Quintanilla, Hospital Severo Ochoa
ClinicalTrials.gov Identifier:
NCT01565993
First received: March 27, 2012
Last updated: April 25, 2012
Last verified: April 2012
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Purpose
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
| Condition | Intervention |
|---|---|
|
Postpolypectomy Bleeding |
Device: Hemoclip Device: Conventional Polipectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study |
Resource links provided by NLM:
Further study details as provided by Hospital Severo Ochoa:
Primary Outcome Measures:
- The Number of Polyps With Complications After Polypectomy (The Total Complication Rate) [ 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 ] [ Designated as safety issue: Yes ]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:
- Difficult to Place the Clip [ Time Frame: During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted) ] [ Designated as safety issue: Yes ]The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.
| Enrollment: | 108 |
| Study Start Date: | July 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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
|
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
|
|
Active Comparator: Conventional Polipectomy
In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
|
Device: 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
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565993
Locations
| Spain | |
| Hospital Universitario Severo Ochoa | |
| Leganés, Madrid, Spain, 28911 | |
Sponsors and Collaborators
Hospital Severo Ochoa
Investigators
| Principal Investigator: | Elvira M Quintanilla, MD | Hospital Universitario Severo Ochoa |
| Study Director: | Luis R Rábago, PhD | Hospital Universitario Severo Ochoa |
More Information
No publications provided
| Responsible Party: | Elvira Quintanilla, Physician, Hospital Severo Ochoa |
| ClinicalTrials.gov Identifier: | NCT01565993 History of Changes |
| Other Study ID Numbers: | EQCLIPS |
| Study First Received: | March 27, 2012 |
| Results First Received: | March 28, 2012 |
| Last Updated: | April 25, 2012 |
| Health Authority: | Spain: Ethics Committee |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013