Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer

Study Overview
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Brief Summary
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This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.

Official Title
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Longitudinal Study of Different Surgical Approaches in Chinese Patients of Cervical Cancer

Conditions
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Uterine Cervical Neoplasms, Laparotomy, Laparoscopy, Survival, Mortality, Recurrence

Intervention / Treatment
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* Procedure: Laparotomic radical hysterectomy
* Procedure: Laparoscopic radical hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological confirmed as uterine cervical cancer Having definite clinical information Having received radical hysterectomy or trachelectomy Exclusion Criteria: Not satisfying any of the inclusion criteria
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparotomy group<br>Patients in this group accepted laparotomic radical hysterectomy for cervical cancer. | Procedure: Laparotomic radical hysterectomy<br>* Radical hysterectomy applied by laparotomy<br>|
| Laparoscopy group<br>Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer. | Procedure: Laparoscopic radical hysterectomy<br>* Radical hysterectomy applied by laparoscopic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. | Five years | 
| Disease-free survival | In cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works. | Five years |