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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparotomy group | Patients in this group accepted laparotomic radical hysterectomy for cervical cancer. |
| |
| Laparoscopy group | Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparotomic radical hysterectomy | Procedure | Radical hysterectomy applied by laparotomy |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Proportion of patients who have been pregnant after the fertility-preserving radical trachelectomy | Five years |
Inclusion Criteria:
Exclusion Criteria:
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All patients pathological confirmed as uterine cervival cancer and receiving radical hysterectomy or trachelectomy would been included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Li, M.D. | Contact | 13911988831 | 86 | lileigh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Li | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32819996 | Derived | Chao X, Wu M, Ma S, Tan X, Zhong S, Song X, Li L. Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China. BMJ Open. 2020 Aug 20;10(8):e038020. doi: 10.1136/bmjopen-2020-038020. |
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All the data will be available to all researchers on the public websites
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Laparoscopic radical hysterectomy |
| Procedure |
Radical hysterectomy applied by laparoscopic |
|
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 |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |