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

Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients With Vaginal Bleeding and/or Endometrial Thickness

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.

Study Overview

• Status: Completed
• Conditions: Post-Menopausal Bleeding; Post-Menopausal Endometrial Thickness
• Intervention / Treatment: 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; Diagnostic test: Endometrial biopsy with the hysteroscopic alligator grasper

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catania, Italy, 95100
    • University of Catania
  • Varese, Italy, 21100
    • University of Insubria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New hysteroscopic grasper; Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws.	Diagnostic test: 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.
Active Comparator: Classic spoon grasper; Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper.	Diagnostic test: Endometrial biopsy with the hysteroscopic spoon grasper; Hysteroscopic endometrial biopsy performed through the spoon grasper.
Active Comparator: Classic alligator grasper; Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper.	Diagnostic test: Endometrial biopsy with the hysteroscopic alligator grasper; Hysteroscopic endometrial biopsy performed through the alligator grasper.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the hysteroscopy	Duration of the hysteroscopic procedure, expressed in minutes and seconds.	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".	During the hysteroscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of attempts	Number of attempts necessary to perform the biopsy	During the hysteroscopy
Size of the specimen	Size of the specimen obtained through biopsy, expressed in mm2	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".	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".	During the hysteroscopy

Collaborators and Investigators

• Sponsor: Università degli Studi dell'Insubria
• Investigators: Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria; Principal Investigator: Salvatore Giovanni Vitale, M.D., Ph.D., University of Catania

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Menopause; Hysteroscopy; Endometrial biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: HYGREB-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No