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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Recruiting

CT.gov ID

NCT04373694

Collaborator

Hologic, Inc. (Industry)

Enrollment

Location

Arms

20.7

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma of Uterus	Procedure: vaginoscopy Procedure: standard hysteroscopy	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 9, 2020

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Standard hysteroscopy

morcellation hysteroscopy with intravenous sedation and paracervical bloc

Procedure: standard hysteroscopy

speculum, paracervical block before hysteroscopy morcellation

Experimental: Vaginoscopy

morcellation hysteroscopy with only intravenous sedation

Procedure: vaginoscopy

vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 52 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHUM - Clinique Médecine et biologie de la reproduction	Montreal	Quebec	Canada	H2X 1P1

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)
Hologic, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre hospitalier de l'Université de Montréal (CHUM)

ClinicalTrials.gov Identifier:

NCT04373694

Other Study ID Numbers:

19.380

First Posted:

May 4, 2020

Last Update Posted:

Aug 6, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)

vaginoscopy

hysteroscopy morcellation

infertile population

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Study Results

No Results Posted as of Aug 6, 2021