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

Not Applicable

Completed

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

• Registration Number: NCT03427957
• Lead Sponsor: Università degli Studi dell'Insubria

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 Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Study Start: 2019-06-01
• Primary Completion: 2020-01-30
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic alligator grasper	Endometrial biopsy with the hysteroscopic alligator grasper	Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic alligator grasper.
New hysteroscopic grasper	Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws	Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the new grasper with knurled terminal end and cutting jaws.
Classic spoon grasper	Endometrial biopsy with the hysteroscopic spoon grasper	Patients allocated in this group will undergo hysteroscopic endometrial biopsy through the classic spoon grasper.

Primary Outcome Measures

Name	Time	Method
Duration of the hysteroscopy	During the hysteroscopy	Duration of the hysteroscopic procedure, expressed in minutes and seconds.
Pain perceived by the patient	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 Outcome Measures

Name	Time	Method
Number of attempts	During the hysteroscopy	Number of attempts necessary to perform the biopsy
Size of the specimen	During the hysteroscopy	Size of the specimen obtained through biopsy, expressed in mm2
Feasibility assessment by the operator	During the hysteroscopy	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".
Precision	During the hysteroscopy	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".

Trial Locations

Locations (2)

University of Catania; 🇮🇹 Catania, Italy

University of Insubria; 🇮🇹 Varese, Italy