Comparison of Two Hysteroscopy Approaches
|ClinicalTrials.gov Identifier: NCT00319410|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : November 28, 2006
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia||Procedure: vaginoscopic hysteroscopy||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A New Approach to Office Hysteroscopy Compared With Traditional Hysteroscopy|
|Study Start Date :||July 2005|
|Estimated Study Completion Date :||December 2005|
- Visual analogue scale for pain
- Patient satisfaction
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319410
|Maccabe Health Maintenance Organization|
|Tel Aviv, Israel|
|Principal Investigator:||Ron Sagiv, M.D.||E. Wolfson Medical Center|