Leiomyoma of Uterus
Conditions
Keywords
vaginoscopy, hysteroscopy morcellation, infertile population
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
Interventions
PROCEDUREvaginoscopy
vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)
PROCEDUREstandard hysteroscopy
speculum, paracervical block before hysteroscopy morcellation
Sponsors
Hologic, Inc.
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
Countries
Canada
Outcome results
None listed