Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.
Primary Purpose
Endometrial Polyps
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
polyps resection with Laser Diode
polyps resection with bipolar electrode
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Polyps focused on measuring endometrial polyp, resection of endometrial polyps, hysteroscopy, bipolar electrode Versapoint, Laser Diode
Eligibility Criteria
Inclusion Criteria:
- patients previously diagnosed of endometrial polyps that can be resected. The diagnosis will be made hysteroscopically. The patient must be informed about the study, and sign the informed consent.
Exclusion Criteria:
- the usual exclusion criteria for surgical techniques, pregnant patients, patiens under 18 patients who did not sign the informed consent
Sites / Locations
- Reina Sofia University Hospital
- Reina Sofía University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
polyps resection with Laser Diode
polyps resection with bipolar electrode
Arm Description
application of the laser diode by hysteroscopy to remove the endometrial polyp
application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp
Outcomes
Primary Outcome Measures
To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale
Secondary Outcome Measures
Determine if complete resection of polyps is achieved with both methods.
Compare the time spent on the removal of the polyp.
To evaluate the safety of both methods
Full Information
NCT ID
NCT02126397
First Posted
January 28, 2014
Last Updated
July 8, 2014
Sponsor
Isabel Bejerano Blázquez
Collaborators
Hospital Universitario Reina Sofia de Cordoba, Universidad Nacional de Córdoba
1. Study Identification
Unique Protocol Identification Number
NCT02126397
Brief Title
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.
Official Title
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Isabel Bejerano Blázquez
Collaborators
Hospital Universitario Reina Sofia de Cordoba, Universidad Nacional de Córdoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hysteroscopy today is considered the gold standard for the diagnosis and treatment of endometrial polyps. In recent years we have used the bipolar energy for resection of polyps by hysteroscopy, becoming a routine clinical practice and universally accepted.
Resection of endometrial polyps laser energy has recently begun to be used with satisfactory results, so studies are needed to analyze these results and compare it with the usual techniques .
This time in advance of medicine, it is appropriate to introduce minimally invasive procedures , allowing resection of endometrial polyps on an outpatient basis without anesthesia and acceptable to most patients.
These procedures assume a lower cost and are associated with a lower surgical risk due to their realization without anesthesia .
Hypothesis: Resection of polyps outpatient laser diode has a similar or superior to that of the bipolar electrode tolerability. The diode laser is a viable , quick , simple technique with a high percentage of resection and high degree of satisfaction of patients
Detailed Description
Main objective: To assess the tolerability of diode laser in the treatment of endometrial polyps using a visual analogue pain scale.
Secondary objectives:
Determine if complete resection of polyps is achieved with both methods.
Compare the time spent on the removal of the polyp in each of the hysteroscopic methods.
To evaluate the safety of the laser diode with respect to the bipolar electrode (vagal syndrome, uterine perforation, infection, bleeding).
Assess the recurrence of polyps after 3 months of resection (via hysteroscopy).
Compare the degree of patient satisfaction with the different methods.
Design: randomized single blind clinical trial corresponds to an experimental analytical study. The patients randomly into 2 groups will include: Group A bipolar electrode treatment Versapoint and Group B diode laser treatment. Randomization was performed using a random table with 2 groups, generated in Microsoft Office Excel. The sample size needed to detect a difference in visual analog pain scale of a point with respect to the laser diode bipolar electrode is calculated; assuming a standard deviation of 1.75, a sample size of 49 patients in each group (98 would be needed in total), to a level of significance of 5% (0.05 α) with a power of 0.80 (beta 0.20). Assuming a loss of individuals from 5 to 10%
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Polyps
Keywords
endometrial polyp, resection of endometrial polyps, hysteroscopy, bipolar electrode Versapoint, Laser Diode
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
polyps resection with Laser Diode
Arm Type
Active Comparator
Arm Description
application of the laser diode by hysteroscopy to remove the endometrial polyp
Arm Title
polyps resection with bipolar electrode
Arm Type
Active Comparator
Arm Description
application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp
Intervention Type
Procedure
Intervention Name(s)
polyps resection with Laser Diode
Intervention Description
resection of endometrial polyps by hysteroscopy without anesthesia
Intervention Type
Procedure
Intervention Name(s)
polyps resection with bipolar electrode
Primary Outcome Measure Information:
Title
To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale
Time Frame
we we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Secondary Outcome Measure Information:
Title
Determine if complete resection of polyps is achieved with both methods.
Time Frame
the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Title
Compare the time spent on the removal of the polyp.
Time Frame
the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Title
To evaluate the safety of both methods
Time Frame
the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Other Pre-specified Outcome Measures:
Title
Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).
Time Frame
3 months after resection of the polyp, repeat hysteroscopy to assess recurrence, in 10 to 15 minutes. the patient is satisfied if foretaste and whether they would recommend the procedure.
Title
Compare the degree of patient satisfaction with the different methods
Time Frame
3 months after resection of the polyp, repeat hysteroscopy to assess recurrence, in 10 to 15 minutes. the patient is satisfied if foretaste and whether they would recommend the procedure.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients previously diagnosed of endometrial polyps that can be resected. The diagnosis will be made hysteroscopically. The patient must be informed about the study, and sign the informed consent.
Exclusion Criteria:
the usual exclusion criteria for surgical techniques, pregnant patients, patiens under 18 patients who did not sign the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Eduardo Arjona Berral, Gynecologist
Organizational Affiliation
Head of the Department of Obstetrics and Gynecology at the University Hospital Reina Sofia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Dolores Lara, Gynecologist
Organizational Affiliation
Physician specializing in obstetrics and gynecology.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rafaela Dios Palomares, Engineer
Organizational Affiliation
Universidad de Córdoba
Official's Role
Study Chair
Facility Information:
Facility Name
Reina Sofia University Hospital
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Reina Sofía University Hospital
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://www.juntadeandalucia.es/servicioandaluzdesalud/hrs3/index.php?id=investigacion
Description
Reina Sofia University Hospital in Cordoba, Spain
URL
http://www.prosego.com/index.php?option=content&task=view&id=598&Itemid=97
Description
protocol hysteroscopy in Spanish society of obstetrics and gynecology
Learn more about this trial
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.
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