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

Study Overview
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Brief Summary
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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
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78 participants will be randomised in two groups: traditional hysteroscopy: under intravenous sedation, hysteroscopic morcellation is perform after speculum insertion, vaginal cleansing, and paracervical anesthesia with xylocain 1%. 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

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

Conditions
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Leiomyoma of Uterus

Intervention / Treatment
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* Procedure: vaginoscopy
* Procedure: standard hysteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard hysteroscopy<br>morcellation hysteroscopy with intravenous sedation and paracervical bloc | Procedure: standard hysteroscopy<br>* speculum, paracervical block before hysteroscopy morcellation<br>|
| Experimental: Vaginoscopy<br>morcellation hysteroscopy with only intravenous sedation | Procedure: vaginoscopy<br>* vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginoscopy, hysteroscopy morcellation, infertile population