Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application

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Brief Title

Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application

Official Title

Depth of Necrosis in Normal Cervical Epithelium After 85% Trichloroacetic Acid (TCA) Application

Brief Summary

      Early detection and treatment of precancerous lesions are the pillars of cervical cancer
      prevention. Cervical Intraepithelial Neoplasia (CIN) is a precancerous lesion that
      histologically can be found in one of three stages of development; CIN-I (low grade), CIN-II,
      or CIN-III (collectively called high grade), depending on the proportion of the depth of the
      lesion to the thickness of the cervical epithelium. The higher the degree of CIN, the deeper
      the pre-cancerous lesions are found in the epithelial lining of the cervix. Therefore, from
      the point of view of precancerous lesions treatment, its effectiveness will be determined by
      the ability to eradicate all high-grade lesions. In other words, it has an effect that can
      reach depths beyond the depth of the high grade lesion.

      According to a study in the US (1982), as many as 99.7% of CIN-III cases had a lesion depth
      of less than 4.8 millimeter. Furthermore, a Netherlands study (1990) stated that as many as
      99.7% of CIN-III cases had a maximum lesion depth of 3.6 millimeters. While in subjects from
      developing countries, study from Peru (2018) showed that 93.5% of CIN-III cases have a lesion
      depth of less than 5 millimeters. Based on the results of these studies, a treatment for CIN
      can only be said to be effective if it can create a therapeutic effect which can reach depths
      of 4-5 millimeters in cervix epithelial.

      Trichloroacetic acid (TCA) is an acetic acid analogue, which has long been known as a
      chemical peel and also frequently used to treat genital ward and precancerous skin lesions.
      The effect of TCA therapy is the destruction of the epithelium forming epithelial necrosis,
      followed by re-epithelialization of the supporting tissue and stimulation of collagen
      synthesis within approximately in 24 hours. There are no studies regarding the depth of
      cervical necrosis that can be achieved by application of this solution to the cervix
      epithelial.
    

Detailed Description

      Primary Objectives:

      The purpose of this study is to determine the depth of epithelial necrosis in cervical tissue
      specimen after 85 percent TCA application on clinically normal cervix.

      Procedure:

      Patients will receive a single administration of 1-2 milliliter of 85 percent TCA in 24 hours
      before elective total hysterectomy surgery on indication other than cervical pathology. The
      85 percent TCA will be applied topically onto the ectocervix and the endocervix canal with a
      cotton swab for 1-2 minutes. After surgery, cervical specimen will be fixated in formalin and
      sent for histopathologic examination.
    


Study Type

Interventional


Primary Outcome

Depth of Cervical Epithelial Ablation

Secondary Outcome

 Pain Scores

Condition

Cervix; Intraepithelial Neoplasia

Intervention

85% TCA Solution

Study Arms / Comparison Groups

 85% TCA Group
Description:  Participants are subject who will undergo an elective total hysterectomy procedure for indications of gynecological organ abnormalities, whether benign, pre-cancerous, or malignant other than cervical pathology.
The 85 percent TCA solution will be applied to participants cervical tissue 24 hours before surgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

April 15, 2021

Completion Date

October 2021

Primary Completion Date

August 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Normal cervix without significant changes and must be tested negative for Visual
             Inspection Acetic-Acid (VIA) test (no acetowhite lesions are found)

          -  Participants are willing to participate voluntarily in this research by signing a
             consent form.

        Exclusion Criteria:

          -  Patients who finally have undergone sub-total or supra-vaginal hysterectomy.

          -  Any abnormalities found in postoperative cervical histopathology results.
      

Gender

Female

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Laila Nuranna, Professor, +628122436967, [email protected]

Location Countries

Indonesia

Location Countries

Indonesia

Administrative Informations


NCT ID

NCT04911075

Organization ID

21020134


Responsible Party

Principal Investigator

Study Sponsor

Indonesia University

Collaborators

 Dr Cipto Mangunkusumo General Hospital

Study Sponsor

Laila Nuranna, Professor, Principal Investigator, Indonesia University


Verification Date

June 2021