Postpolypectomy Bleeding
Conditions
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-)
Interventions
DEVICEHemoclip
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
DEVICEConventional 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
Sponsors
Hospital Severo Ochoa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Polyps With Complications After Polypectomy (The Total Complication Rate) | Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding | 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
| Measure | Time frame | Description |
|---|---|---|
| Difficult to Place the Clip | During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted) | The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short. |
Countries
Spain
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 66 |
| Group B: Conventional Polipectomy In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique | 42 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 3 |
Baseline characteristics
| Characteristic | Group B: Conventional Polipectomy | Group A: Hemoclips | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 65 Participants | 106 Participants |
| Age Continuous | 65.55 years STANDARD_DEVIATION 12.68 | 64.05 years STANDARD_DEVIATION 10.99 | 64.5 years STANDARD_DEVIATION 11.24 |
| Region of Enrollment Spain | 42 participants | 66 participants | 108 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 24 Participants | 49 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 66 | 0 / 39 |
| serious Total, serious adverse events | 1 / 66 | 0 / 39 |
Outcome results
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
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hemoclip | The Number of Polyps With Complications After Polypectomy (The Total Complication Rate) | 7 polyps |
| Conventional Polipectomy | The Number of Polyps With Complications After Polypectomy (The Total Complication Rate) | 3 polyps |
Secondary
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)