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The unexpected increase in morbidity of the hemoclip group
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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-)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemoclip | Active Comparator | 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 | Active Comparator | In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemoclip | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Difficult to Place the Clip | The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short. | During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elvira M Quintanilla, MD | Hospital Universitario Severo Ochoa | Principal Investigator |
| Luis R Rábago, PhD | Hospital Universitario Severo Ochoa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23687606 | Derived | 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. | |
| 23687598 |
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Where more than one polyp was observed in a patient, all the polyps were included in the same randomization group, so that they all underwent the same technique (conventional or modified polypectomy). 3 patients were excluded for failing to meet the inclusion criteria since they involved semi-pedunculated polyps measuring less than 1cm.
From 2007 to 2010, the patients were selected at the digestive endoscopy unit.All of the consecutive patients referred for colonoscopy to the endoscopy office were informed of the aims of the ongoing research and were invited to take part in the study for which they gave their informed consent before the endoscopic procedure was performed
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Hemoclips | In group A, 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 |
| FG001 | Group B: Conventional Polipectomy | In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Hemoclips | In group A, 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 |
| BG001 | Group B: Conventional Polipectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Based on an anticipated decrease of at least 12% in the rate of adverse bleeding events between the group A and the group B, there was an alpha error of 0.05 and a statistical power of 80% with a patient inclusion rate of 1:1. The number of polyps required is 146 per group. Using the Fleiss correction, the final number is 164 per group. | Posted | Number | polyps | Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding | Polyps | Participants |
|
During the endoscopic procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A: Hemoclips | In group A, 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Surgical and medical procedures | Perforation | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucosal burn | Injury, poisoning and procedural complications | Mucosal burn | Non-systematic Assessment |
Not to reach the sample size established previously in the initial design, implies bias and decreases the strength of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra Elvira Quintanilla | Hospital Universitario Severo Ochoa | 34 914818000 | 8326 | elviramquintanilla@hotmail.com |
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| Conventional Polipectomy | Device | 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 |
|
| 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. |
In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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. In all the polypectomies that were assigned to group 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
| OG001 | Conventional Polipectomy | In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.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. |
|
|
| Secondary | Difficult to Place the Clip | The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short. | Not Posted | During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted) |
| 1 |
| 66 |
| 3 |
| 66 |
| EG001 | Group B: Conventional Polipectomy | In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique | 0 | 39 | 0 | 39 |
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