Clinical trial NCT03427957: Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients
Official title: Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Menopausal Bleeding
Post-Menopausal Endometrial Thickness
Keywords: Hysteroscopy
Endometrial biopsy
Menopause
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 75
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of the hysteroscopy
timeFrame: During the hysteroscopy
measure: Pain perceived by the patient
timeFrame: During the hysteroscopy
Secondary outcomes:
measure: Number of attempts
timeFrame: During the hysteroscopy
measure: Size of the specimen
timeFrame: During the hysteroscopy
measure: Feasibility assessment by the operator
timeFrame: During the hysteroscopy
measure: Precision
timeFrame: During the hysteroscopy
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
city: Varese
country: Italy
facility: University of Insubria
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Catania
name: Salvatore Giovanni Vitale, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.