Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Detailed Description

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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%

Conditions

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Endometrial Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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polyps resection with Laser Diode

application of the laser diode by hysteroscopy to remove the endometrial polyp

Group Type ACTIVE_COMPARATOR

polyps resection with Laser Diode

Intervention Type PROCEDURE

resection of endometrial polyps by hysteroscopy without anesthesia

polyps resection with bipolar electrode

application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp

Group Type ACTIVE_COMPARATOR

polyps resection with bipolar electrode

Intervention Type PROCEDURE

Interventions

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polyps resection with Laser Diode

resection of endometrial polyps by hysteroscopy without anesthesia

Intervention Type PROCEDURE

polyps resection with bipolar electrode

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes