A Cohort Study for the Following up of Conization

Study Overview
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Brief Summary
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This study is to investigate the oncologic and obstetric outcomes in patients with conization for uterine cervical lesions from January 1, 2000 to January 1, 2019 in Peking Union Medical College Hospital. The primary objectives consist of following: The cumulative incidences of precancerous lesions and cancers of lower genital tract in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009) The cumulative pregnancy rates in patients sparing the fertility The secondary objectives consist of following: The effects of surgical protocols (modified Sturmdorf method and 8 figure suture) and energy equipment (cold knife and monopolar electrical cautery) on the oncologic and obstetric outcomes, and on the histological components. A full description of histological components of the conization specimens The cytological and virus outcomes after conization, based on the thin prep liquid-based cytology test (TCT) and high-risk human papillomavirus (HPV) testing

Official Title
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Oncologic and Obstetric Outcomes After Conization for Uterine Cervical Lesion: A Cohort Study

Conditions
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Precancerous Lesions, Conization, High Grade Intraepithelial Neoplasia, Uterine Cervical Cancer, Fertility, Pregnancy, Human Papillomavirus Infection

Intervention / Treatment
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* Diagnostic Test: High-risk HPV
* Diagnostic Test: TCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accepting conization in the study center Aged 18 years or older Exclusion Criteria: Not meeting any of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: High-risk HPV|High-risk HPV testing for the cytology of lower genital tract|
|Diagnostic Test: TCT|Thin prep liquid-based cytology test for the cytology of lower genital tract|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cumulative incidences of precancerous lesions or cancers | The cumulative incidences of precancerous lesions and cancers of lower genital track in patients who accepted conization for high grade intraepithelial neoplasia (HSIL), carcinoma in situ and stage IA1 cancer (FIGO 2009) | Five years | 
| The cumulative pregnancy rates | The cumulative pregnancy rates in patients sparing the fertility | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cytological results after conization | The cytological after conization based on the thin prep liquid-based cytology test (TCT) | Five years | 
| The virus outcomes after conization | The virus outcomes after conization high-risk human papillomavirus (HPV) testing | Five years | 
| The cumulative pregnancy loss rates | The cumulative pregnancy loss rates in patients sparing the fertility | Five years | 
| The cumulative live birth rates | The cumulative live birth rates in patients sparing the fertility | Five years |