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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Low pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure..
Procedure/SurgeryLow pressure: Operative hysteroscopy without anesthesia with normal Saline medium in low pressure.. Operative hysteroscopy without anesthesia using normal Saline as medium with different pressure according to the arm allocated. The procedure is done for endometrial polyp removal, retained products of conception removal, intrauterine adhesyolisis and intrauterine device removal.
High pressure: Operative hysteroscopy without anesthesia with normal Saline medium in High pressure.
Procedure/SurgeryHigh pressure: Operative hysteroscopy without anesthesia with normal Saline medium at high pressure.
Treatment groups
Trial outcomes
Primary outcomes
To compare the rate of successful completion rate of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium.
The feasibility and success of the procedure would be evaluated by the surgeon using a questionnaire.
Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.
Feasibility and uterine cavity visibility of operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium. The feasibility of the procedure would be evaluated by the surgeon using a questionnaire.
Secondary outcomes
Patients' discomfort during operative hysteroscopy without anesthesia using low versus high pressure normal saline for distention medium.
Patients' discomfort during operative hysteroscopy without anesthesia using low pressure (100 mmHg) versus high pressure (150 mmHg) normal saline for distention medium measured by VAS.
Locations
Sponsors and contacts
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