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NOT YET RECRUITING
NCT06620978
NA

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

Sponsor: Assaf-Harofeh Medical Center

View on ClinicalTrials.gov

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.

Official title: Operative Hysteroscopy Without Anaesthesia: Impact of Different Distention Medium Pressure (Using Normal Saline) on Visibility, Feasibility and Patients' Discomfort

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2024-11-01

Completion Date

2025-12-31

Last Updated

2024-10-02

Healthy Volunteers

No

Interventions

PROCEDURE

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

Low 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.

PROCEDURE

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

High pressure: Operative hysteroscopy without anesthesia with normal Saline medium at high pressure.