Comparison of Two Hysteroscopy Approaches
Primary Purpose
Menorrhagia
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
vaginoscopic hysteroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Menorrhagia focused on measuring Menorrhagia, intrauterine diagnosis, visual analogue scale
Eligibility Criteria
Inclusion Criteria:adult female, referred for outpatient diagnostic hysteroscopy, subscriber to Maccabe health maintenance organization - Exclusion Criteria:heavy vaginal bleeding; severe cervical stenosis; patients refusing the examination on an outpatient basis. -
Sites / Locations
- Maccabe Health Maintenance Organization
Outcomes
Primary Outcome Measures
Visual analogue scale for pain
Patient satisfaction
Secondary Outcome Measures
Full Information
NCT ID
NCT00319410
First Posted
April 27, 2006
Last Updated
November 27, 2006
Sponsor
Wolfson Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00319410
Brief Title
Comparison of Two Hysteroscopy Approaches
Official Title
A New Approach to Office Hysteroscopy Compared With Traditional Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
5. Study Description
Brief Summary
This randomized clinical trial compares two methods of diagnostic hysteroscopy: vaginoscopic hysteroscopy vs. traditional method. Pain intensity was estimated using a visual analogue scale (VAS), and patient satisfaction was evaluated. These endpoints were compared by treatment assignment. Vaginoscopic hysteroscopy was associated with significantly lower VAS scores, indicating reduced experience of pain in this treatment group; however, this was not associated with improved patient satisfaction.
Detailed Description
OBJECTIVE: To compare the vaginoscopic approach of diagnostic hysteroscopy without anesthesia with the traditional diagnostic hysteroscopy after intracervical injection of Mepivacaine Hydrochloride 3%.
METHODS: A total of 130 women undergoing diagnostic hysteroscopy were included in the study and were randomized, using a computer-generated randomization list, into two groups with a ratio of 2:1. Eighty three women underwent vaginoscopy without speculum, tenaculum or anesthesia. Forty seven women received intracervical anesthesia with 10 ml of 3% mepivacaine hydrochloride solution injected at two sites (3:00 and 9:00 positions) and underwent traditional hysteroscopy using a speculum and tenaculum. Hysteroscopy was performed using a rigid 3.7 mm hysteroscope in a medium of 0.9% saline, and the image was transmitted to a screen visible to the patient. A Visual Scale Analogue (VAS) consisting of a 10 cm line was used to assess the intensity of pain experienced during and after the procedure. Overall patient satisfaction was assessed during, immediately after, 15 minutes later, and three days post hysteroscopy.
RESULTS: The mean pain score was significantly lower in the vaginoscopy group (3.8±2.7 vs 5.34±3.23, p=0.01). Patient satisfaction rate was similar in both groups.
CONCLUSION: Patients reported significantly less pain with the vaginoscopic approach to diagnostic hysteroscopy even without anesthesia compared to patients undergoing the traditional procedure with anesthesia. This new approach should therefore be considered as a replacement for the traditional hysteroscopic technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
Menorrhagia, intrauterine diagnosis, visual analogue scale
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
vaginoscopic hysteroscopy
Primary Outcome Measure Information:
Title
Visual analogue scale for pain
Title
Patient satisfaction
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:adult female, referred for outpatient diagnostic hysteroscopy, subscriber to Maccabe health maintenance organization -
Exclusion Criteria:heavy vaginal bleeding; severe cervical stenosis; patients refusing the examination on an outpatient basis.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Sagiv, M.D.
Organizational Affiliation
E. Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maccabe Health Maintenance Organization
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
16880310
Citation
Sagiv R, Sadan O, Boaz M, Dishi M, Schechter E, Golan A. A new approach to office hysteroscopy compared with traditional hysteroscopy: a randomized controlled trial. Obstet Gynecol. 2006 Aug;108(2):387-92. doi: 10.1097/01.AOG.0000227750.93984.06.
Results Reference
result
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Comparison of Two Hysteroscopy Approaches
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