Clinical Trial

Impact of Different Saline Pressures During Hysteroscopy on Visibility, Feasibility and Patients' Discomfort

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Record status
This record was last updated October 2, 2024 (before its estimated September 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Diagnostic procedures are often performed without anaesthesia (in the office setting) and operative procedures are performed either under general anaesthesia or without anaesthesia (in the office setting). It depends on the patients' characteristics and preferences, and surgical indications. 80%-100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity. In the current study, the investigators will compare the use of two different pressure setting of the liquid media during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure and patient's discomfort, with the aim of determining the optimal pressure setting.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-27.
Trial Details
NCT Number NCT06620978
Lead Sponsor Assaf-Harofeh Medical Center
Conditions Endometrial Polyps, Retained Products of Conception, Lysis of Intrauterine Adhesions, Removal of Retained Intrauterine Device
Enrollment 100 participants
Start Date 2024-11-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-02