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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02126397
Enrollment
98
Registered
2014-04-30
Start date
2013-05-31
Completion date
2014-05-31
Last updated
2014-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Polyps

Keywords

endometrial polyp, resection of endometrial polyps, hysteroscopy, bipolar electrode Versapoint, Laser Diode

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%

Interventions

PROCEDUREpolyps resection with Laser Diode

resection of endometrial polyps by hysteroscopy without anesthesia

PROCEDUREpolyps resection with bipolar electrode

Sponsors

Hospital Universitario Reina Sofia de Cordoba
CollaboratorOTHER_GOV
Universidad Nacional de Córdoba
CollaboratorOTHER
Isabel Bejerano Blázquez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scalewe we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks

Secondary

MeasureTime frame
Determine if complete resection of polyps is achieved with both methods.the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
Compare the time spent on the removal of the polyp.the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
To evaluate the safety of both methodsthe duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes

Other

MeasureTime frame
Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).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.
Compare the degree of patient satisfaction with the different methods3 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026