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

Primary Purpose

Leiomyoma of Uterus

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
vaginoscopy
standard hysteroscopy
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma of Uterus focused on measuring vaginoscopy, hysteroscopy morcellation, infertile population

Eligibility Criteria

18 Years - 52 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHUM - Clinique Médecine et biologie de la reproduction

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard hysteroscopy

Vaginoscopy

Arm Description

morcellation hysteroscopy with intravenous sedation and paracervical bloc

morcellation hysteroscopy with only intravenous sedation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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
Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
length of time in months to be pregnant after procedure

Full Information

First Posted
April 23, 2020
Last Updated
January 11, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Hologic, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04373694
Brief Title
Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial
Official Title
Pain Perception During Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Hologic, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma of Uterus
Keywords
vaginoscopy, hysteroscopy morcellation, infertile population

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard hysteroscopy
Arm Type
Active Comparator
Arm Description
morcellation hysteroscopy with intravenous sedation and paracervical bloc
Arm Title
Vaginoscopy
Arm Type
Experimental
Arm Description
morcellation hysteroscopy with only intravenous sedation
Intervention Type
Procedure
Intervention Name(s)
vaginoscopy
Intervention Description
vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)
Intervention Type
Procedure
Intervention Name(s)
standard hysteroscopy
Intervention Description
speculum, paracervical block before hysteroscopy morcellation
Primary Outcome Measure Information:
Title
Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
Description
10 point visual analog pain scale: 0 for no pain to 10 for unbearable pain
Time Frame
immediately after intervention
Secondary Outcome Measure Information:
Title
Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group
Description
length of time in minutes between start and end of procedure including morcellation
Time Frame
immediately after intervention
Title
Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group
Description
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.
Time Frame
immediately after surgery
Title
Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group
Description
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
Time Frame
immediatly after surgery
Title
Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group
Description
length of time in months to continue fertility treatment after procedure
Time Frame
up to 1 year
Title
Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
Description
length of time in months to be pregnant after procedure
Time Frame
up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carole KAMGA-NGANDE, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUM - Clinique Médecine et biologie de la reproduction
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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