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

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.

Trial Description

Primary Outcome:

  • Difference in pain perception between vaginoscopy group and traditional hysteroscopy group
Secondary Outcome:
  • Difference in length of time of procedure between vaginoscopy group and traditional hysteroscopy group
  • Difference in proportion of vasovagal syncope between vaginoscopy group and traditional hysteroscopy group
  • Difference in proportion of uterine perforation between vaginoscopy group and traditional hysteroscopy group
  • Difference in length of time to continue fertility treatment between vaginoscopy group and traditional hysteroscopy group
  • Difference in length of time to pregnancy between vaginoscopy group and traditional hysteroscopy group
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

View this trial on ClinicalTrials.gov

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Resources

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