None listed
Conditions
Brief summary
Outpatient hysteroscopy stands out as a safe, effective, and well-tolerated modality for investigating and treating intrauterine pathology. However, despite its advantages, outpatient hysteroscopy accounts for less than 0.5% of all hysteroscopies performed in Australia, largely due to the prohibitive upfront capital costs associated with setting up these services. This study aims to overcome this barrier by evaluating the LiNA OperaScope, an innovative all-in-one single-use hysteroscope device, to determine its patient and clinician acceptability and its cost-effectiveness compared to traditional methods. We hypothesise that single use hysteroscopy will be comparable to reusable hysteroscopy in effectiveness and may provide a most cost-effective option for clinicians to offer outpatient hysteroscopy to their patients.
Interventions
The intervention being examined is the use of a single use compared with a reusable hysteroscope in the context of outpatient diagnostic hysteroscopy procedures. Participants will be recruited from the outpatient hysteroscopy service prior to or on the day of planned procedure. After screening the medical record ensuring conditions of inclusion and exclusion criteria are met, a member of the research team or clinician will gain informed consent from the participant and complete the enrolment form. Once enrolled in the study and after consent, participants will be randomly allocated 1:1 to have outpatient hysteroscopy using the single use device or conventional outpatient hysteroscopy. The procedure will be performed by a consultant gynaecologist from the Endosurgery Unit or a RANZCOG trainee level 5 or above who has performed at least 10 outpatient hysteroscopies in the preceding 12 months. Hysteroscopy will be performed using either conventional hysteroscopic device or single use device using a vaginoscopic approach where the hysteroscope is passed through the vagina and into the cervical canal using normal saline as distension medium. If a vaginoscopic technique is unsuccessful, local anaesthetic spray to the cervix or injection for intracervical or paracervical block may be administered to allow cervical dilatation for access the cavity. The findings at hysteroscopy are documented with intraoperative photographs. Any additional procedures such as removal of an endometrial polyp, endometrial sampling or an intrauterine device (IUD) insertion may be performed once hysteroscope is complete. Information for any operative procedure, sampling or IUD insertion will not be analysed for the purpose of this study, only the information for the diagnostic hysteroscopy procedure will be assessed. The procedure takes approximately 5-10 minutes. For patients allocated to have their procedure with a single use hysteroscope, this will be performed with LiNA OperaScope. The LiNA OperaScope is a single-use, battery operated hysteroscopy device with a Liquid-crystal (LCD) display. It comes in a sterilised set with separate instruments available for biopsy and polyp removal available. A recording module can use used alongside the hysteroscope to allow for image capture and video recording of the procedure. An operative report is documented for every procedure performed. For the purposes of the study, an audit of all reusable and disposable items will be recorded.
Sponsors
Study design
Eligibility
Inclusion criteria
• Age 18 years or above • Planned outpatient hysteroscopy • Patient consent • English speakers
Exclusion criteria
• Planned operative hysteroscopic procedure for myomectomy or large polypectomy (when procedure is planned to commence with operative scope and Myosure XL) • Symptoms of or confirmed infection • Pregnancy • Previous failed outpatient hysteroscopic access • Previous vasovagal reaction with cervical procedures or outpatient hysteroscopy