Clinical trial NCT02126397: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Polyps
Keywords: endometrial polyp
resection of endometrial polyps
hysteroscopy
bipolar electrode Versapoint
Laser Diode
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Reina Sofia de Cordoba
name: Universidad Nacional de Córdoba
First posted: 2014-04-30
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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%

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

Primary outcomes:
measure: To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale
timeFrame: we we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks
Secondary outcomes:
measure: Determine if complete resection of polyps is achieved with both methods.
timeFrame: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
measure: Compare the time spent on the removal of the polyp.
timeFrame: the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes
measure: To evaluate the safety of both methods
timeFrame: 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:
measure: Assess the recurrence of polyps after 3 months of resection (another hysteroscopy).
timeFrame: 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.
measure: Compare the degree of patient satisfaction with the different methods
timeFrame: 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.
Locations:
city: Cordoba
country: Spain
facility: Reina Sofia University Hospital
city: Cordoba
country: Spain
facility: Reina Sofía University Hospital
Study officials:
affiliation: Head of the Department of Obstetrics and Gynecology at the University Hospital Reina Sofia
name: José Eduardo Arjona Berral, Gynecologist
role: STUDY_DIRECTOR
affiliation: Physician specializing in obstetrics and gynecology.
name: Maria Dolores Lara, Gynecologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Córdoba
name: Rafaela Dios Palomares, Engineer
role: STUDY_CHAIR
References: