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| Name | Class |
|---|---|
| Hospital Universitario Reina Sofia de Cordoba | OTHER_GOV |
| Universidad Nacional de Córdoba | OTHER |
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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:
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%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| polyps resection with Laser Diode | Active Comparator | application of the laser diode by hysteroscopy to remove the endometrial polyp |
|
| polyps resection with bipolar electrode | Active Comparator | application of the bipolar electrode Versapoint by hysteroscopy to remove the endometrial polyp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyps resection with Laser Diode | Procedure | resection of endometrial polyps by hysteroscopy without anesthesia |
|
| Measure | Description | 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 |
| Measure | Description | 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. |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reina Sofia University Hospital | Córdoba | Cordoba | 14004 | Spain | ||
| Reina Sofía University Hospital |
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| Label | URL |
|---|---|
| Reina Sofia University Hospital in Cordoba, Spain | View source |
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| polyps resection with bipolar electrode | Procedure |
|
| 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 |
| 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. |
| Córdoba |
| Cordoba |
| 14004 |
| Spain |
| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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