Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hologic, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
78 participants will be randomised in two groups:
In addition to pain perception, other outcomes includes: complication rates, time to continue fertility treatment, time to pregnancy
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard hysteroscopy | Active Comparator | morcellation hysteroscopy with intravenous sedation and paracervical bloc |
|
| Vaginoscopy | Experimental | morcellation hysteroscopy with only intravenous sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginoscopy | Procedure | vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carole KAMGA-NGANDE, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUM - Clinique Médecine et biologie de la reproduction | Montreal | Quebec | H2X 1P1 | Canada |
Not provided
| ID | Term |
|---|---|
| D047708 | Myofibroma |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| standard hysteroscopy | Procedure | speculum, paracervical block before hysteroscopy morcellation |
|
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 |
| 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 |
| 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 |
| 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 |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |