Comparison of Two Hysteroscopy Approaches

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ClinicalTrials.gov Identifier: NCT00319410

Recruitment Status : Completed

First Posted : April 27, 2006

Last Update Posted : November 28, 2006

Sponsor:

Information provided by:

Wolfson Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Menorrhagia	Procedure: vaginoscopic hysteroscopy	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	130 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	A New Approach to Office Hysteroscopy Compared With Traditional Hysteroscopy
Study Start Date :	July 2005
Study Completion Date :	December 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Visual analogue scale for pain
Patient satisfaction

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319410

Locations


Israel
Maccabe Health Maintenance Organization
Tel Aviv, Israel

Sponsors and Collaborators

Wolfson Medical Center

Investigators


Principal Investigator:	Ron Sagiv, M.D.	E. Wolfson Medical Center

More Information

Publications of Results:

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.


ClinicalTrials.gov Identifier:	NCT00319410 History of Changes
Other Study ID Numbers:	EWMCgyn-1
First Posted:	April 27, 2006 Key Record Dates
Last Update Posted:	November 28, 2006
Last Verified:	April 2006

Keywords provided by Wolfson Medical Center:


Menorrhagia intrauterine diagnosis visual analogue scale

Additional relevant MeSH terms:


Menorrhagia Uterine Hemorrhage Uterine Diseases	Genital Diseases, Female Menstruation Disturbances Pathologic Processes

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