search
Back to results

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
Isabel Bejerano Blázquez
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

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
search

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.

We'll reach out to this number within 24 hrs