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

Centre hospitalier de l'Université de Montréal (CHUM)78 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leiomyoma of Uterus

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 52 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: immediately after intervention

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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