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

NCT02126397 | Completed DMC

• 1 other identifier: 230485
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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

Conditions

Endometrial Polyps

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 Outcomes (2)

• 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.

Study Arms (2)

polyps resection with Laser Diode

ACTIVE COMPARATOR

application of the laser diode by hysteroscopy to remove the endometrial polyp

Procedure: polyps resection with Laser Diode

polyps resection with bipolar electrode

ACTIVE COMPARATOR

application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp

Procedure: polyps resection with bipolar electrode

Interventions

polyps resection with Laser Diode PROCEDURE

resection of endometrial polyps by hysteroscopy without anesthesia

polyps resection with Laser Diode

polyps resection with bipolar electrode PROCEDURE

polyps resection with bipolar electrode

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Isabel Bejerano Blázquez: lead
• Hospital Universitario Reina Sofia de Cordoba: collaborator
• Universidad Nacional de Córdoba: collaborator

Study Sites (2)

Reina Sofia University Hospital

Córdoba, Cordoba, 14004, Spain

Location

Reina Sofía University Hospital

Córdoba, Cordoba, 14004, Spain

Location

Related Links

• Reina Sofia University Hospital in Cordoba, Spain

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• José Eduardo Arjona Berral, Gynecologist

  Head of the Department of Obstetrics and Gynecology at the University Hospital Reina Sofia

  STUDY DIRECTOR

• Maria Dolores Lara, Gynecologist

  Physician specializing in obstetrics and gynecology.

  PRINCIPAL INVESTIGATOR

• Rafaela Dios Palomares, Engineer

  Universidad de Córdoba

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: IMIBIC

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: April 30, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 10, 2014

Record last verified: 2014-07

Locations

ES (2)