Post-Menopausal Bleeding, Post-Menopausal Endometrial Thickness
Conditions
Keywords
Hysteroscopy, Endometrial biopsy, Menopause
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTEndometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws
Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.
DIAGNOSTIC_TESTEndometrial biopsy with the hysteroscopic spoon grasper
Hysteroscopic endometrial biopsy performed through the spoon grasper.
DIAGNOSTIC_TESTEndometrial biopsy with the hysteroscopic alligator grasper
Hysteroscopic endometrial biopsy performed through the alligator grasper.
Sponsors
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to the type of grasper used to perform hysteroscopic endometrial biopsy.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the hysteroscopy | During the hysteroscopy | Duration of the hysteroscopic procedure, expressed in minutes and seconds. |
| Pain perceived by the patient | During the hysteroscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts | During the hysteroscopy | Number of attempts necessary to perform the biopsy |
| Size of the specimen | During the hysteroscopy | Size of the specimen obtained through biopsy, expressed in mm2 |
| Feasibility assessment by the operator | During the hysteroscopy | 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. |
| Precision | During the hysteroscopy | 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. |
Countries
Italy
Outcome results
None listed