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

NCT06620978 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-02

No results posted yet for this study

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.

Conditions

  • Endometrial Polyps
  • Retained Products of Conception
  • Lysis of Intrauterine Adhesions
  • Removal of Retained Intrauterine Device

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.

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Principal Investigators

  • Neta Eisenberg Kogan · Assaf-Harofeh Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-09-01
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620978 on ClinicalTrials.gov