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

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Active, not recruiting

Conditions: Leiomyoma of Uterus

Treatments: Procedure: vaginoscopy; Procedure: standard hysteroscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04373694

19.380

Details and patient eligibility

About

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.

Full description

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

Enrollment: 78 estimated patients

Sex: Female

Ages: 18 to 52 years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• cervical stenosis
• polyp or fibroid more than 2 cm
• pregnancy
• blood dyscrasia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Standard hysteroscopy

Active Comparator group

Description:

morcellation hysteroscopy with intravenous sedation and paracervical bloc

Treatment:

Procedure: standard hysteroscopy

Vaginoscopy

Experimental group

Description:

morcellation hysteroscopy with only intravenous sedation

Treatment:

Procedure: vaginoscopy