Clinical trial NCT04373694: Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
Official title: Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leiomyoma of Uterus
Keywords: vaginoscopy
hysteroscopy morcellation
infertile population
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2020-05-04
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
timeFrame: immediately after intervention
Secondary outcomes:
measure: Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group
timeFrame: immediately after intervention
measure: Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group
timeFrame: immediately after surgery
measure: Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group
timeFrame: immediatly after surgery
measure: Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group
timeFrame: up to 1 year
measure: Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: CHUM - Clinique Médecine et biologie de la reproduction
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Carole KAMGA-NGANDE, MD
role: PRINCIPAL_INVESTIGATOR
References: