Cost-Benefit Analysis, Laparoscopy, Laparotomy, Morbidity, Mortality, Pelvic Floor Disorders, Quality of Life, Survival, Uterine Cervical Neoplasm
Conditions
Brief summary
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.
Interventions
PROCEDURELaparotomic radical hysterectomy
Laparotomic radical hysterectomy for patients without fertility requirement
PROCEDURELaparotomic radical trachelectomy
Laparotomic radical hysterectomy for patients with fertility requirement
PROCEDURELaparoscopic radical hysterectomy
Laparoscopic radical hysterectomy for patients without fertility requirement
PROCEDURELaparoscopic radical trachelectomy
Laparoscopic radical hysterectomy for patients with fertility requirement
Sponsors
Lei Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix * FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1 * Type II or III radical hysterectomy or trachelectomy * Performance status of ECOG 0-1 * Aged 18 years or older * Signed an approved informed consents
Exclusion criteria
* Not satisfying any of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Five years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Morbidity rate | Six months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Urodynamics | Five years | Urinary functions are measured by dynamic tests before and after surgeries |
| Sex function | Five years | Sex function measured by academic questionnaire before and after surgeries |
| Rectal functions | Five years | Rectal functions are measured by dynamic tests before and after surgeries |
| Cost-effectiveness of different surgical routes | One year | The direct cost of different surgical routes |
| Quality of life | Three years | The quality of life measured by academic questionnaire |
Countries
China
Contacts
Primary ContactLei Li, M.D.
Outcome results
None listed