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

NCT04373694 | Unknown

• 1 other identifier: 19.380
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyoma of Uterus

Keywords

vaginoscopy; hysteroscopy morcellation; infertile population

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group

  immediately after intervention

• Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group

  immediately after surgery

• Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group

  immediatly after surgery

• Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group

  up to 1 year

• Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group

  up to 1 year

Study Arms (2)

Standard hysteroscopy

ACTIVE COMPARATOR

morcellation hysteroscopy with intravenous sedation and paracervical bloc

Procedure: standard hysteroscopy

Vaginoscopy

EXPERIMENTAL

morcellation hysteroscopy with only intravenous sedation

Procedure: vaginoscopy

Interventions

vaginoscopy PROCEDURE

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

Vaginoscopy

standard hysteroscopy PROCEDURE

speculum, paracervical block before hysteroscopy morcellation

Standard hysteroscopy

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• cervical stenosis
• polyp or fibroid more than 2 cm
• pregnancy
• blood dyscrasia

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Hologic, Inc.: collaborator

Study Sites (1)

CHUM - Clinique Médecine et biologie de la reproduction

Montreal, Quebec, H2X 1P1, Canada

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carole KAMGA-NGANDE, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 4, 2020
• Study Start: September 9, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

CA (1)