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

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

resection of endometrial polyps by hysteroscopy without anesthesia

polyps resection with Laser Diode

polyps resection with bipolar electrode

José Eduardo Arjona Berral, Gynecologist

Maria Dolores Lara, Gynecologist

Rafaela Dios Palomares, Engineer

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%

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

Hospital Universitario Reina Sofia de Cordoba

Universidad Nacional de Córdoba

Isabel Bejerano Blázquez

IMIBIC

Skin and Connective Tissue Diseases

Hemorrhage

Leiomyoma

Myofibroma

Uterine Hemorrhage

Menorrhagia

Endometrial sample obtained using the H Pipelle

Endometrial sample obtained with standard Pipelle

Endometrial biopsy taken on completion of office/outpatient diagnostic hysteroscopy

Endometrial biopsy

Adam Magos, BSc MD FRCOG

The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy

Royal Free Hampstead NHS Trust

Adam Magos BSc MB BS MD FRCOG, Consultant Gynaecologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparative Study of Endometrial Polypectomy Performed With Bipolar Electrode Versapoint and Laser Diode. A Randomised Controlled Trial.	NCT02126397	Endometrial Pol...	polyps resectio... polyps resectio...	18 Years -	Maimónides Biomedical Research Institute of Córdoba
Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy	NCT00755651	Abnormal Uterin...	Endometrial bio...	20 Years - 80 Years	Royal Free Hampstead NHS Trust

Spots Global Cancer Trial Database for endometrial polyps