Mini-hysteroscopy Versus Conventional Office Hysteroscopy in Nulliparous Patients Undergoing Diagnostic Office Hysteroscopy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Cairo University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Intensity of pain
Study Overview
Brief Summary
The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
Detailed Description
The results of the studies comparing the pain experienced by the patients undergoing conventional office hysteroscopy or mini-hysteroscopy were mixed. Several studies revealed that mini-hysteroscopy significantly reduced the procedure related pain and other studies revealed that the use of mini-hysteroscope was not associated with significant reduction in the procedure related pain. The aim of this study is to evaluate the effect of hysteroscope diameter on the pain experienced by nulliparous patients undergoing diagnostic office hysteroscopy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Nulliparous patients
Exclusion Criteria
- •Parous patients, menopausal status, cervical pathology, and previous cervical surgery
Outcomes
Primary Outcomes
Intensity of pain
Time Frame: up to 30 minutes
Intensity of pain assessed by the Visual Analog Scale (VAS)"
Secondary Outcomes
- Duration of procedure(intraoperative)
Investigators
Usama M Fouda
M.D, PhD
Cairo University