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

NCT03427957 | Completed

• 1 other identifier: HYGREB-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Menopausal Bleeding; Post-Menopausal Endometrial Thickness

Keywords

Hysteroscopy; Endometrial biopsy; Menopause

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of attempts

  During the hysteroscopy

• Size of the specimen

  During the hysteroscopy

• Feasibility assessment by the operator

  During the hysteroscopy

• Precision

  During the hysteroscopy

Study Arms (3)

New hysteroscopic grasper

EXPERIMENTAL

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

Classic spoon grasper

ACTIVE COMPARATOR

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

Diagnostic Test: Endometrial biopsy with the hysteroscopic spoon grasper

Classic alligator grasper

ACTIVE COMPARATOR

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

Diagnostic Test: Endometrial biopsy with the hysteroscopic alligator grasper

Interventions

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

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

New hysteroscopic grasper

Endometrial biopsy with the hysteroscopic spoon grasper DIAGNOSTIC_TEST

Hysteroscopic endometrial biopsy performed through the spoon grasper.

Classic spoon grasper

Endometrial biopsy with the hysteroscopic alligator grasper DIAGNOSTIC_TEST

Hysteroscopic endometrial biopsy performed through the alligator grasper.

Classic alligator grasper

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physiologic menopause
• Vaginal bleeding or endometrial thickness (\>5 mm)

You may not qualify if:

• Hormonal replacement therapies
• Other known causes of vaginal/cervical bleeding
• Suspected or known cancer(s)
• Premature or iatrogenic menopause
• Uterine cervix stenosis

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (2)

University of Catania

Catania, 95100, Italy

Location

University of Insubria

Varese, 21100, Italy

Location

Related Publications (1)

• 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.

  PMID: 33686708 DERIVED

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

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

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to the type of grasper used to perform hysteroscopic endometrial biopsy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 9, 2018
• Study Start: June 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: March 1, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)