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I have found it is quite difficult to conduct the work without changing some detail in original protocol. So we would like to re-start the study again with some modification.
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To evaluate the efficacy of topical 95% TCA in the treatment of CIN 1 or less after low grade abnormality of screening test
The patients meeting inclusion criteria were initially divided into two groups which are no lesion and having lesion at cervix on colposcopic examination.
Participant in no lesion group were divided into two group, recieving 95% Trichloroacetic acid (intervention) plus aceteic acid (commonly apply at cervix during colposcopic examination) applying to the cervix at T-zone and Acetic acid alone group.
We follow-up each group for 6 months to evaluate the outcome using cytologic examination, HPV testing and colposcopic examination (also biopsy if lesion is seen) compare to previous result (before treatment)
In the group having lesion at cervix, we initially biopsy the lesion and wait for pathologic result. If the pathologic results are high-grade lesion e.g. HSIL, we exclude them from this study. On the contrary, if the pathologic result s are low-grade lesion, we divided them into two group, normal pathologic exam and low-grade abnormality on pathologic examination. Both of them are divided into two groups and follow-up for 6 months, similar to the no lesion group
* During colposcopic examination, we also repeat cytologic examination and HPV testing as well
** Pregnancy test is done before applying 95%Trichloroacetic acid and at the time of follow-up. If positive at any point of time, participants are excluded from the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCA plus acetic acid 1 | Experimental | No lesion group, |
|
| Acetic acid 1 | No Intervention | No lesion group, Applying acetic acid which normally used during colposcopic examination at transformation zone during colposcopic examination | |
| TCA plus acetic acid 2 | Experimental | Having lesion with normal pathologic examination |
|
| Acetic acid 2 | No Intervention | Having lesion with normal pathologic examination, Applying acetic acid which normally used during colposcopic examination at transformation zone and lesion during colposcopic examination | |
| TCA plus acetic acid 3 | Experimental | Having lesion with low-grade abnomality on pathologic examination, |
|
| Acetic acid 3 | No Intervention | Having lesion with low-grade abnomality on pathologic examination, Applying acetic acid which normally used during colposcopic examination at transformation zone and lesion during colposcopic examination |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trichloroacetic acid | Drug | Applying Trichloroacetic acid 95 % topical solution plus acetic acid at the transformation zone or lesion (if have) of the cervix during colposcopic examination (95% topical trichloroacetic acid is used just before finishing examination, while acetic acid is used normally when perform colposcopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with cytologic examination, HPV testing and colposcopic examination with biopsy ( Efficacy of 95%Trichloroacetic acid in the treatment of CIN1 or less) | using cytologic examination, HPV testing and colposcopic examination with biopsy (if having lesion) compare to previous results If all of the test's results are normal, we consider it as remission of CIN1 or less *normal means: Cytologic examination = Negative for intraepithelial lesion or malignancy HPV testing = no HPV detected Colposcopic examination not seen any lesion = normal (not perform biopsy) Colposcopic examination with biopsy = normal pathlogic result | 6 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Pain after treatment which evaluated by using visual analogue scale | Sides effect of 95%Trichloroacetic acid | immediately after intervention, up to 2 weeks after intervention |
| Having leukorrhea or not? which is recorded by questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi hospital | Phaya Thai | Bangkok | 10400 | Thailand |
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| ID | Term |
|---|---|
| D014238 | Trichloroacetic Acid |
| D019342 | Acetic Acid |
| ID | Term |
|---|---|
| D062845 | Chloroacetates |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
|
Sides effect of 95%Trichloroacetic acid
| immediately after intervention, up to 2 weeks after intervention |
| Having abnormal vaginal bleeding or not? which is recorded by questionnaire | Sides effect of 95%Trichloroacetic acid | immediately after intervention, up to 2 weeks after intervention |
| D009930 |
| Organic Chemicals |
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |