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

Università degli Studi dell'Insubria

Status: Completed

Conditions: Post-Menopausal Bleeding; Post-Menopausal Endometrial Thickness

Treatments: Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper; 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

Study type: Interventional

Funder types: Other

Identifiers

NCT03427957

HYGREB-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

New hysteroscopic grasper

Experimental group

Description:

Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws.

Treatment:

Diagnostic Test: Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws

Classic spoon grasper

Active Comparator group

Description:

Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper.

Treatment:

Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasper

Classic alligator grasper

Active Comparator group

Description:

Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper.

Treatment:

Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper