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

Study Overview

• Status: Completed
• Conditions: Endometrial Polyps
• Intervention / Treatment: Procedure: polyps resection with Laser Diode; Procedure: polyps resection with bipolar electrode

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%

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cordoba, Spain, 14004
    • Reina Sofia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: polyps resection with Laser Diode; application of the laser diode by hysteroscopy to remove the endometrial polyp	Procedure: polyps resection with Laser Diode; resection of endometrial polyps by hysteroscopy without anesthesia
Active Comparator: polyps resection with bipolar electrode; application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp	Procedure: polyps resection with bipolar electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time 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 methods	the duration of the polyp resection, subsequent assessment of the patient and her general condition. Time is measured, between 15 to 30 minutes

Other Outcome Measures

Outcome Measure	Time 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 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.

Collaborators and Investigators

• Sponsor: Isabel Bejerano Blázquez
• Collaborators: Hospital Universitario Reina Sofia de Cordoba; Universidad Nacional de Córdoba
• Investigators: Study Director: José Eduardo Arjona Berral, Gynecologist, Head of the Department of Obstetrics and Gynecology at the University Hospital Reina Sofia; Principal Investigator: Maria Dolores Lara, Gynecologist, Physician specializing in obstetrics and gynecology.; Study Chair: Rafaela Dios Palomares, Engineer, Universidad de Córdoba

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: hysteroscopy; endometrial polyp; resection of endometrial polyps; bipolar electrode Versapoint; Laser Diode
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Pathological Conditions, Anatomical; Polyps; Uterine Neoplasms
• Other Study ID Numbers: 230485