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

Endometrial Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126397
• Other study ID #: 230485
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: July 8, 2014
• Start date: May 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

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%

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometrial Polyps
• Polyps
• Uterine Neoplasms

Intervention

Procedure:
• polyps resection with Laser Diode
resection of endometrial polyps by hysteroscopy without anesthesia
• polyps resection with bipolar electrode

Locations

Country	Name	City	State
Spain	Reina Sofia University Hospital	Cordoba
Spain	Reina Sofía University Hospital	Cordoba

Sponsors (3)

Lead Sponsor	Collaborator
Isabel Bejerano Blázquez	Hospital Universitario Reina Sofia, Universidad Nacional de Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Yes
Other	Compare the degree of patient satisfaction with the different methods		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.	Yes
Primary	To assess the tolerability of the laser diode in the treatment of endometrial polyps using a validated visual analogue pain scale		we we measure pain after resection of endometrial polyps, with 5 minutes for the patient thinks	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	To evaluate the safety of 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	Yes

External Links

•   laser diodo in Cordoba, Spain
•   protocol hysteroscopy in Spanish society of obstetrics and gynecology
•   Reina Sofia University Hospital in Cordoba, Spain