Trials / Unknown
UnknownNCT04373694
Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
- Sex
- Female
- Age
- 18 Years – 52 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | vaginoscopy | vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps) |
| PROCEDURE | standard hysteroscopy | speculum, paracervical block before hysteroscopy morcellation |
Timeline
- Start date
- 2020-09-09
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2020-05-04
- Last updated
- 2023-01-12
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT04373694. Inclusion in this directory is not an endorsement.