A New Alternative to Traditional Hysteroscopy

Study Overview
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Brief Summary
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Hysteroscopy is a procedure designed for the diagnosis and the treatment of intra-uterine diseases. The development of smaller hysteroscopes allowed to change the approach to the intra-uterine lesions unifying the diagnostic and operative time. Recently Gubbini et al. developed a mini-resectoscope feasible for see&treat hysteroscopy. The objective of the study is to compare the new 16 Fr mini28 resectoscope by Gubbini with Traditional 22 Fr resectoscope and Bettocchi 15 Fr hysteroscope for the treatment of uterine cavitary lesions. The investigators enrolled 401 women affected by endometrial polyps and/or G0 myomas, randomly allocated to receive the treatment with traditional resectoscope (127 women), with mini-resectoscope by Gubbini (142 women) and Bettocchi hysteroscope (132 women). Operating time, distension media delivered, dismiss time and discomfort experienced were recorded.

Official Title
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New Mini-resectoscope as Alternative to Traditional Hysteroscopy in the Treatment of Uterine Lesions

Conditions
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Intrauterine Diseases, Myomas, Polyps

Intervention / Treatment
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* Procedure: resectoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women between 18-75 years of age endometrial polyps and/or G0 myomas smaller than 3 cm of diameter

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mini-resectoscope<br> | Procedure: resectoscopy<br>* hysteroscopy for myomas G0 and/or polyps<br>|
| Active Comparator: tradiorional resectoscope<br> | Procedure: resectoscopy<br>* hysteroscopy for myomas G0 and/or polyps<br>|
| Active Comparator: bettocchi resectoscope<br> | Procedure: resectoscopy<br>* hysteroscopy for myomas G0 and/or polyps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the whole group of 401 patients | Operating time (min), distension media used (ml), dismiss time (hours), patients discomfort (VAS) | sixteen months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of the treatment with mini-resectoscope in comparison with the traditional hysteroscopy in the treatment of intrauterine lesions larger than 1,5cm in diameter | Operating time(min), distension media used (ml), dismiss time (hours), patients discomfort (VAS) | sixteen months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrial pathology