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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Leiomyoma of Uterus
• Intervention / Treatment: Procedure: standard hysteroscopy; Procedure: vaginoscopy

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

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 1P1
      • CHUM - Clinique Médecine et biologie de la reproduction

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 52 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Hologic, Inc.
• Investigators: Principal Investigator: Carole KAMGA-NGANDE, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: vaginoscopy; hysteroscopy morcellation; infertile population
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: 19.380

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No