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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.
Hysteroscopic endometrial biopsy performed through the spoon grasper.
Hysteroscopic endometrial biopsy performed through the alligator grasper.
University of Catania
Catania, Italy
University of Insubria
Varese, Italy
Duration of the hysteroscopy
Duration of the hysteroscopic procedure, expressed in minutes and seconds.
Time frame: 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".
Time frame: During the hysteroscopy
Number of attempts
Number of attempts necessary to perform the biopsy
Time frame: During the hysteroscopy
Size of the specimen
Size of the specimen obtained through biopsy, expressed in mm2
Time frame: 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".
Time frame: 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".
Time frame: During the hysteroscopy
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