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Spots Global Cancer Trial Database for Vaginoscopy Compared to Traditional Hysteroscopy for Hysteroscopy Morcellation in Outpatient Clinic. A Randomized Trial

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Trial Identification

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 ID: NCT04373694

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: 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

CHUM - Clinique Médecine et biologie de la reproduction, Montreal, Quebec, Canada

Contact Details

Name: Carole KAMGA-NGANDE, MD

Affiliation: Centre hospitalier de l'Université de Montréal (CHUM)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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