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

Not Applicable

Active, not recruiting

• Conditions: Leiomyoma of Uterus

• Registration Number: NCT04373694
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-04
• Study Start: 2020-09-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in pain perception between vaginoscopy group and traditional hysteroscopy group	immediately after intervention	10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain

Secondary Outcome Measures

Name	Time	Method
Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group	immediately after intervention	length of time in minutes between start and end of procedure including morcellation
Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group	immediatly after surgery	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
Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group	up to 1 year	length of time in months to continue fertility treatment after procedure
Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group	immediately after surgery	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.
Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group	up to 1 year	length of time in months to be pregnant after procedure

Trial Locations

Locations (1)

CHUM - Clinique Médecine et biologie de la reproduction; 🇨🇦 Montreal, Quebec, Canada