Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 75
- Locations
- 4
- Primary Endpoint
- Duration of the hysteroscopy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Patients will be blinded to the type of grasper used to perform hysteroscopic endometrial biopsy.
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Duration of the hysteroscopy
Time Frame: During the hysteroscopy
Duration of the hysteroscopic procedure, expressed in minutes and seconds.
Pain perceived by the patient
Time Frame: 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 Outcomes
- Number of attempts(During the hysteroscopy)
- Size of the specimen(During the hysteroscopy)
- Feasibility assessment by the operator(During the hysteroscopy)
- Precision(During the hysteroscopy)
Investigators
Antonio Simone Laganà
Medical Doctor
Università degli Studi dell'Insubria