Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2024-12-31

Brief Summary

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This study is a randomized controlled trial take place in a fertility outpatient clinic in an academic hospital. Women between 18 and 52 years old requiring polypectomy or myomectomy by hysteroscopy morcellation for abnormal uterine bleeding or for fertility issue are included. The aim is to evaluate pain perception between vaginal and traditional hysteroscopy for hysteroscopic morcellation. The investigator's hypothesis is that pain perception is lower using vaginoscopy compared to traditional hysteroscopy.

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Detailed Description

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78 participants will be randomised in two groups:

1. traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%.
2. Vaginal hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after vaginal cleansing using vaginal distension with saline solution

In addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy

Conditions

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Leiomyoma of Uterus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard hysteroscopy

morcellation hysteroscopy with intravenous sedation and paracervical bloc

Group Type ACTIVE_COMPARATOR

standard hysteroscopy

Intervention Type PROCEDURE

speculum, paracervical block before hysteroscopy morcellation

Vaginoscopy

morcellation hysteroscopy with only intravenous sedation

Group Type EXPERIMENTAL

vaginoscopy

Intervention Type PROCEDURE

vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)

Interventions

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vaginoscopy

vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)

Intervention Type PROCEDURE

standard hysteroscopy

speculum, paracervical block before hysteroscopy morcellation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* polyp or fibroid previously diagnosed by hysteroscopy
* polyp less than 2 cm
* submucosal fibroid (type 0 or 1 according to the 2011 FIGO uterine fibroid classification) less than 2 cm
* if more than 1 fibroid: total fibroid have to be less or equal 4 cm