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NCT Number: NCT02126397

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

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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Key information

Conditions

Endometrial Polyps

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Reina Sofia University Hospital, Córdoba, Cordoba, Spain

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About this study

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%

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polyps resection with Laser Diode

Procedure

resection of endometrial polyps by hysteroscopy without anesthesia

polyps resection with bipolar electrode

Procedure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Isabel Bejerano Blázquez

Other

Collaborators

  • Hospital Universitario Reina Sofia de Cordoba
  • Universidad Nacional de Córdoba

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 30, 2014
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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