Trial Outcomes & Findings for The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps (NCT NCT01565993)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

108 participants

Primary outcome timeframe

Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding

Results posted on

2012-05-25

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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	Group B: Conventional Polipectomy In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
Overall Study STARTED	66	42
Overall Study COMPLETED	66	39
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Group B: Conventional Polipectomy In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
Overall Study Physician Decision	0	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: Hemoclips n=66 Participants 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	Group B: Conventional Polipectomy n=42 Participants In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants	41 Participants n=7 Participants	106 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	64.05 years STANDARD_DEVIATION 10.99 • n=5 Participants	65.55 years STANDARD_DEVIATION 12.68 • n=7 Participants	64.5 years STANDARD_DEVIATION 11.24 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	24 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment Spain	66 participants n=5 Participants	42 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Hemoclip n=66 Polyps 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	Conventional Polipectomy n=39 Polyps 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.
The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)	7 polyps	3 polyps

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Group A: Hemoclips

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Group B: Conventional Polipectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A: Hemoclips n=66 participants at risk 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	Group B: Conventional Polipectomy n=39 participants at risk In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
Surgical and medical procedures Perforation	1.5% 1/66 • Number of events 1 • During the endoscopic procedure	0.00% 0/39 • During the endoscopic procedure

Other adverse events

Other adverse events
Measure	Group A: Hemoclips n=66 participants at risk 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	Group B: Conventional Polipectomy n=39 participants at risk In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
Injury, poisoning and procedural complications Mucosal burn	4.5% 3/66 • Number of events 3 • During the endoscopic procedure	0.00% 0/39 • During the endoscopic procedure

Additional Information

Dra Elvira Quintanilla

Hospital Universitario Severo Ochoa

Phone: 34 914818000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place