Endometrial Polyps Clinical Trial
Official title:
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
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%
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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