Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000425796
Ethics application status
Approved
Date submitted
6/04/2013
Date registered
16/04/2013
Date last updated
16/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Office hysteroscopy in the diagnosis of Cervical Intra-epithelial Neoplasia.
Scientific title
Office hysteroscopy in the diagnostic workup of cervical glandular intraepithelial neoplasia in patients with cervical intraepithelial neoplasia.
Secondary ID [1] 282210 0
none
Universal Trial Number (UTN)
U1111-1141-2377
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervix cancer screening 288730 0
Condition category
Condition code
Cancer 289086 289086 0 0
Cervical (cervix)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 286887 0
Early detection / Screening
Intervention code [2] 286888 0
Diagnosis / Prognosis
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289258 0
assessment of the ability of office hysteroscopy for diagnosis of endocervical lesions. The assessment based on visualization of the endocervical abnormalities by office hysteroscopy and after application of 5 % acetic acid to delineate the abnormalities. these finding will be compared to endocervical curettage.
Timepoint [1] 289258 0
At time of examination, all abnormalities will be recorded and will be compared with the results of endocervical curettage. At the end of the study the overall results of hysteroscopy will be compared with the overall results of endocervical curettage.
Secondary outcome [1] 302118 0
The prevalence of endocervical lesions in patents referred with abnormal cytology and/or abnormal visual inspection of the cervix after application of acetic acid (VIA) testing of the cervix.
Timepoint [1] 302118 0
At the end of the study. the percentage of histological proven endocervical abnormalities will be calculated.

Eligibility
Key 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)
Minimum age
21 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data analysis will be performed with statistical software (SPSS version 20, IBM Corporation, Armonk, NY). The data will be assessed with visual (histogram and probability plot) and analytical methods (Kolmogorov-Smirnov test) to evaluate
normal distribution. The ?² test (chi-square test) or Fisher exact test will be used to compare proportions of outcome grades in different groups. Pearson product moment correlation will be performed for correlations. Statistical significance is defined by P = .05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 4986 0
Egypt
State/province [1] 4986 0
Minia

Funding & Sponsors
Funding source category [1] 287030 0
Hospital
Name [1] 287030 0
Minia maternity University Hospital
Country [1] 287030 0
Egypt
Primary sponsor type
Hospital
Name
Minia Maternity University Hospital
Address
Minia- Minia University. Faculty of Medicine. Egypt.
Country
Egypt
Secondary sponsor category [1] 285810 0
None
Name [1] 285810 0
Address [1] 285810 0
Country [1] 285810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289066 0
scientific ethical committee of the department of Obstetrics and Gynecology
Ethics committee address [1] 289066 0
Ethics committee country [1] 289066 0
Egypt
Date submitted for ethics approval [1] 289066 0
Approval date [1] 289066 0
25/04/2011
Ethics approval number [1] 289066 0
Ethics committee name [2] 289067 0
Institutional Review Board of the University Hospital-Quality control unit of the Faculty of Medicine, Minia University
Ethics committee address [2] 289067 0
Ethics committee country [2] 289067 0
Egypt
Date submitted for ethics approval [2] 289067 0
Approval date [2] 289067 0
01/11/2012
Ethics approval number [2] 289067 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38846 0
Dr Ahmad Sameer Sanad
Address 38846 0
Minia University, Minia Maternity University Hospital. Misr -Aswan main road, Minia city, minia Governorate, postcode: 61111
Country 38846 0
Egypt
Phone 38846 0
+201000222994
Fax 38846 0
+2-086-2332666
Email 38846 0
[email protected]
Contact person for public queries
Name 38847 0
Ahmad Sameer Sanad
Address 38847 0
Minia University, Minia Maternity University Hospital, Misr -Aswan main road, Minia city, minia Governorate, postcode: 61111
Country 38847 0
Egypt
Phone 38847 0
+201000222994
Fax 38847 0
+2-086-2332666
Email 38847 0
[email protected]
Contact person for scientific queries
Name 38848 0
Ahmad Sameer Sanad
Address 38848 0
Minia University, Minia Maternity University Hospital, Misr -Aswan main road, Minia city, minia Governorate, postcode: 61111
Country 38848 0
Egypt
Phone 38848 0
+201000222994
Fax 38848 0
+2-086-2332666
Email 38848 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.