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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssaf-Harofeh Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

Women age >18 years

Willing to undergo operative hysteroscopy without anesthesia for

Disqualifiers

Contraindication for hysteroscopy including: suspected pregnancy, heavy concomitant vaginal bleeding, known genital tract malignancy, suspected concurrent genital tract infection.

Unable to sign informed consent

Unable to read/write Hebrew

Trial design

Treatments tested in this trial

  • Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..
  • High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators