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

Leiomyoma of Uterus Clinical Trial

Official title:

Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04373694
• Other study ID #: 19.380
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma
• Leiomyoma of Uterus

Intervention

Procedure:
• vaginoscopy
vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)
• standard hysteroscopy
speculum, paracervical block before hysteroscopy morcellation

Locations

Country	Name	City	State
Canada	CHUM - Clinique Médecine et biologie de la reproduction	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Hologic, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in pain perception between vaginoscopy group and traditional hysteroscopy group	10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain	immediately after intervention
Secondary	Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group	length of time in minutes between start and end of procedure including morcellation	immediately after intervention
Secondary	Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group	Presence of jerky abnormal movements or a slow weak pulse rate associated to at least one symptoms: nausea, pale skin, blurred vision, warm feeling or cold sweat.	immediately after surgery
Secondary	Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group	presence of one or more signs during intervention: extension of the instrument goes beyong the limitation of the uterus, loss of resistance, sudden loss of vision, direct visualisation of the perforation	immediatly after surgery
Secondary	Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group	length of time in months to continue fertility treatment after procedure	up to 1 year
Secondary	Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group	length of time in months to be pregnant after procedure	up to 1 year