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.

Status Completed

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

Clinical Trial 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 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

• NCT number: NCT02126397
• Study type: Interventional
• Source: Maimónides Biomedical Research Institute of Córdoba
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Completion date: May 2014