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

NCT ID: NCT03427957

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-03-01

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.

Conditions

Post-Menopausal Bleeding; Post-Menopausal Endometrial Thickness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

New hysteroscopic grasper

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.

Classic spoon grasper

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

Group Type: ACTIVE_COMPARATOR

Endometrial biopsy with the hysteroscopic spoon grasper

Intervention Type: DIAGNOSTIC_TEST

Hysteroscopic endometrial biopsy performed through the spoon grasper.

Classic alligator grasper

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

Group Type: ACTIVE_COMPARATOR

Endometrial biopsy with the hysteroscopic alligator grasper

Intervention Type: DIAGNOSTIC_TEST

Hysteroscopic endometrial biopsy performed through the alligator grasper.

Interventions

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

Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.

Intervention Type: DIAGNOSTIC_TEST

Endometrial biopsy with the hysteroscopic spoon grasper

Hysteroscopic endometrial biopsy performed through the spoon grasper.

Intervention Type: DIAGNOSTIC_TEST

Endometrial biopsy with the hysteroscopic alligator grasper

Hysteroscopic endometrial biopsy performed through the alligator grasper.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Antonio Simone Laganà

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Simone Laganà, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Salvatore Giovanni Vitale, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

University of Catania

Catania, , Italy

University of Insubria

Varese, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 33686708 (View on PubMed)

Other Identifiers

HYGREB-1

Identifier Type: -

Identifier Source: org_study_id