Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients

Study Overview
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Brief Summary
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Hysteroscopic endometrial biopsy is usually performed through the classic spoon grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients. This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.

Detailed Description
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Diagnostic hysteroscopy is currently the gold standard method to evaluate uterine cavity and tubal ostia, allowing also the visualization of vaginal walls and the cervical canal. Compared to the other available diagnostic techniques, hysteroscopy has the advantage of directly visualization the anatomical area to be investigated and allows to perform biopsy. The possibility of hysteroscopy-guided biopsy sampling is particularly important in order to get histological diagnosis. As recently suggested, the hysteroscopic biopsy of the endometrium has diagnostic accuracy of 90% for post-menopausal endometrial cancer. Currently, most diagnostic hysteroscopies are performed in outpatient setting, without anesthesia, using modern hysteroscopes with a 1.67 mm working channel. In particular, endometrial biopsy is usually performed through the classic spoon grasper or alligator grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients. This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.

Official Title
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Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness

Conditions
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Post-Menopausal Bleeding, Post-Menopausal Endometrial Thickness

Intervention / Treatment
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* Diagnostic Test: Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws
* Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasper
* Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physiologic menopause Vaginal bleeding or endometrial thickness (>5 mm) Exclusion Criteria: Hormonal replacement therapies Other known causes of vaginal/cervical bleeding Suspected or known cancer(s) Premature or iatrogenic menopause Uterine cervix stenosis

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 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
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New hysteroscopic grasper<br>Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws. | Diagnostic Test: Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws<br>* Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.<br>|
| Active Comparator: Classic spoon grasper<br>Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper. | Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasper<br>* Hysteroscopic endometrial biopsy performed through the spoon grasper.<br>|
| Active Comparator: Classic alligator grasper<br>Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper. | Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper<br>* Hysteroscopic endometrial biopsy performed through the alligator grasper.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the hysteroscopy | Duration of the hysteroscopic procedure, expressed in minutes and seconds. | During the hysteroscopy | 
| Pain perceived by the patient | Subjective evaluation of the pain perceived by the patient during the procedure, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means No pain and 10 The worst imaginable pain. | During the hysteroscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts | Number of attempts necessary to perform the biopsy | During the hysteroscopy | 
| Size of the specimen | Size of the specimen obtained through biopsy, expressed in mm2 | During the hysteroscopy | 
| Feasibility assessment by the operator | Subjective assessment by the operator of the feasibility of performing the biopsy, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means No feasible at all and 10 The most feasible event I could imagine. | During the hysteroscopy | 
| Precision | Subjective assessment by the operator of the precision of the biopsy, expressed through a 0-10 Visual Analogue Scale (VAS) score, where 0 means No precise at all and 10 The most precise event I could imagine. | During the hysteroscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysteroscopy, Endometrial biopsy, Menopause