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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:
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
History of Changes
Results First Received: March 28, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Postpolypectomy Bleeding
Interventions: Device: Hemoclip
Device: Conventional Polipectomy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Group A: Hemoclips     Group B: Conventional Polipectomy  
STARTED     66     42 [1]
COMPLETED     66 [2]   39  
NOT COMPLETED     0     3  
Physician Decision                 0                 3  
[1] 3 patients were excluded for failing to meet the inclusion criteria
[2] A total of 105 polypectomies were performed on 98 patients



  Baseline Characteristics
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Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Group A: Hemoclips     Group B: Conventional Polipectomy     Total  
Number of Participants  
[units: participants]
 		  66     42     108  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     65     41     106  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation 		  64.05  ± 10.99     65.55  ± 12.68     64.5  ± 11.24  
Gender  
[units: participants]
 		     
Female     17     18     35  
Male     49     24     73  
Region of Enrollment  
[units: participants]
 		     
Spain     66     42     108  



  Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   Difficult to Place the Clip   [ Time Frame: During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Not to reach the sample size established previously in the initial design, implies bias and decreases the strength of the study.  


Results Point of Contact:  
Name/Title: Dra Elvira Quintanilla
Organization: Hospital Universitario Severo Ochoa
phone: 34 914818000 ext 8326
e-mail: elviramquintanilla@hotmail.com


No publications provided


Responsible Party: Elvira Quintanilla, 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