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This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparotomic radical hysterectomy | Active Comparator |
| |
| Laparotomic radical trachelectomy | Active Comparator |
| |
| Laparoscopic radical hysterectomy | Active Comparator |
| |
| Laparoscopic radical trachelectomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparotomic radical hysterectomy | Procedure | Laparotomic radical hysterectomy for patients without fertility requirement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | The length of time during and after the treatment of a disease, such as 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. | Five years |
| Disease-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness of different surgical routes | The direct cost of different surgical routes | One year |
| Quality of life | The quality of life measured by academic questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|
| 33317612 | Derived | Chao X, Li L, Wu M, Wu H, Ma S, Tan X, Zhong S, Lang J. Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China. Trials. 2020 Dec 14;21(1):1022. doi: 10.1186/s13063-020-04938-3. | |
| 32502439 | Derived | Ferrandina G, Corrado G, Scambia G. Minimally invasive surgery and quality of life in cervical cancer. Lancet Oncol. 2020 Jun;21(6):746-748. doi: 10.1016/S1470-2045(20)30161-3. No abstract available. |
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The data will be available to all the researches via public websites.
The data will be available once the papers were accepted and be available for ever
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| Laparotomic radical trachelectomy | Procedure | Laparotomic radical hysterectomy for patients with fertility requirement |
|
| Laparoscopic radical hysterectomy | Procedure | Laparoscopic radical hysterectomy for patients without fertility requirement |
|
| Laparoscopic radical trachelectomy | Procedure | Laparoscopic radical hysterectomy for patients with fertility requirement |
|
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.
| Five years |
| Morbidity rate | Refers to having a disease or a symptom of disease, or to the amount of disease within a population. In this study, morbidity of six months from the surgery is defined according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Six months |
| Three years |
| Sex function | Sex function measured by academic questionnaire before and after surgeries | Five years |
| Urodynamics | Urinary functions are measured by dynamic tests before and after surgeries | Five years |
| Rectal functions | Rectal functions are measured by dynamic tests before and after surgeries | Five years |
| 31362966 | Derived | Chao X, Li L, Wu M, Ma S, Tan X, Zhong S, Lang J, Cheng A, Li W. Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China. BMJ Open. 2019 Jul 29;9(7):e029055. doi: 10.1136/bmjopen-2019-029055. |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D059952 | Pelvic Floor Disorders |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
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