Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2021-12-20

Brief Summary

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Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.

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Detailed Description

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Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies.

A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies

Conditions

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Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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5FR + 7FR

Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 5FR then 7 FR

Group Type OTHER

Endometrial sampling

Intervention Type DEVICE

Endometrial sampling with 2 different forceps

7FR + 5FR

Each woman is its own control and had biopsies with the 2 size of forceps. In this group first with 7FR then 5FR

Group Type OTHER

Endometrial sampling

Intervention Type DEVICE

Endometrial sampling with 2 different forceps

Interventions

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Endometrial sampling

Endometrial sampling with 2 different forceps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.

* Woman who speak and understand french
* Woman who give her written informed consent
* Woman covered by french medical insurance

Exclusion Criteria

* • Pregnant or breastfeeding patient

* Patient under guardianship, curators or safeguard of justice.
* Patient participating in another ongoing study.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No