Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Laparotomy group Patients in this group accepted laparotomic radical hysterectomy for cervical cancer. |
Procedure: Laparotomic radical hysterectomy
Radical hysterectomy applied by laparotomy
|
| Laparoscopy group Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer. |
Procedure: Laparoscopic radical hysterectomy
Radical hysterectomy applied by laparoscopic
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [Five years]
Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse
Secondary Outcome Measures
- Overall survival [Five years]
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.
- Disease-free survival [Five years]
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.
Other Outcome Measures
- Pregnancy rate [Five years]
Proportion of patients who have been pregnant after the fertility-preserving radical trachelectomy
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lei Li | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Lei Li
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SACCC