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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New hysteroscopic grasper | Experimental | Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws. |
|
| Classic spoon grasper | Active Comparator | Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper. |
|
| Classic alligator grasper | Active Comparator | Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws | Diagnostic Test | Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Simone Laganà , M.D., Ph.D. | Università degli Studi dell'Insubria | Principal Investigator |
| Salvatore Giovanni Vitale, M.D., Ph.D. | University of Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Catania | Catania | 95100 | Italy | |||
| University of Insubria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33686708 | Derived | Vitale SG, Lagana AS, Caruso S, Garzon S, Vecchio GM, La Rosa VL, Casarin J, Ghezzi F. Comparison of three biopsy forceps for hysteroscopic endometrial biopsy in postmenopausal patients (HYGREB-1): A multicenter, single-blind randomized clinical trial. Int J Gynaecol Obstet. 2021 Dec;155(3):425-432. doi: 10.1002/ijgo.13669. Epub 2021 Apr 4. |
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Randomized controlled trial
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Patients will be blinded to the type of grasper used to perform hysteroscopic endometrial biopsy.
| Endometrial biopsy with the hysteroscopic spoon grasper | Diagnostic Test | Hysteroscopic endometrial biopsy performed through the spoon grasper. |
|
| Endometrial biopsy with the hysteroscopic alligator grasper | Diagnostic Test | Hysteroscopic endometrial biopsy performed through the alligator grasper. |
|
| 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 |
| Varese |
| 21100 |
| Italy |