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Office hysteroscopy in the diagnosis of Cervical Intra-epithelial Neoplasia.

Office hysteroscopy in the diagnostic workup of cervical glandular intraepithelial neoplasia in patients with cervical intraepithelial neoplasia.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000425796
Enrollment
140
Registered
2013-04-16
Start date
2013-05-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of our study is to evaluate the role of office hysteroscopy (endocervicoscopy) as a new technique for the diagnostic work-up of cervical intraepithelial neoplasia. This technique combines, conventional hysteroscopic instrumentation with the colposcopic classification system for the evaluation of the endocervical mucosa

Interventions

Office hysteroscopy for evaluation of endocervix in cases with CIN The office hysteroscopic procedure is carried out with: 1. A 4-mm continuous-flow office operative hysteroscope with a 30-degree rod lens 1.9-mm optic. 2. A xenon light source of 175 W. Because the endocervix is generally small-sized, the light intensity should be as low as possible to avoid the reflection phenomenon, which may hamper the identification of the acetowhite areas. 3. A digital endo-camera 4. A high resolution monit

Office hysteroscopy for evaluation of endocervix in cases with CIN The office hysteroscopic procedure is carried out with: 1. A 4-mm continuous-flow office operative hysteroscope with a 30-degree rod lens 1.9-mm optic. 2. A xenon light source of 175 W. Because the endocervix is generally small-sized, the light intensity should be as low as possible to avoid the reflection phenomenon, which may hamper the identification of the acetowhite areas. 3. A digital endo-camera 4. A high resolution monitor . 5. Distension of the endocervix is obtained using saline solution. The next step is the application of 2 mL of 5% acetic acid on the endocervix through the operative channel. a vaginoscopic approach may be used. The vagina may be distended by introducing the fluid distention medium through the hysteroscope placed into the lower vagina at the same pressure used for the subsequent distention of the uterine cavity. As soon as the external uterine orifice is visualized, the irrigation of saline is stopped and a syringe with 2 mL of 5% acetic acid is connected to the inflow channel of the hysteroscope. In this way the impregnation of the cervix may be directly and clearly visualized, provided that a few minutes elapse before reconnecting the continuous-flow irrigation to the hysteroscope the duration of patient observations depending on the results of gold standard histopathology (period from diagnostic hysteroscopy till results of histopathology) The observation period of the trial will be 6 months

Sponsors

Minia Maternity University Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1- negative pregnancy test. 2- histopathologically proven SIL. 3- Had a satisfactory colposcopic examination (visualization of the squamocolumnar junction and the entire lesion)

Exclusion criteria

1- Suspicion or evidence of invasive lesions on Papanicolaou smear, biopsy, or colposcopic examination. 2- Positive pregnancy test. 3- Current pelvic inflammatory disease, cervicitis, or other gynecological infection 4- Poor compliance.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026