Uterine Cervical Neoplasm Clinical Trial
Official title:
Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer, A Multicenter, Prospective and Non-Randomized Controlled Trial
Cervical cancer is the most common cause of death from gynecological cancer world-wide. With
technological innovation, minimally invasive or even non-invasive medical treatment has
become a trend. Since the first cases of laparoscopic radical hysterectomy of cervical cancer
have been reported in 1992, many single-center observational cohort studies have shown that
compared to open abdominal surgery ,minimally invasive surgery (laparoscopic or robotic
radical hysterectomy) showed advantages of less blood loss, shorter hospital stay and fewer
intraoperative complications, while the 5-year survival and disease-free survival were
similar. The NCCN guidelines and ESGO recommendations also clearly indicated that patients
with FIGO stage IA2 -IIA cervical cancer could undergo open or laparoscopic/robotic radical
hysterectomy. However, in October 2018, the results of two studies published in the《New
England Journal of Medicine》have subverted our traditional perception of minimally invasive
surgery and caused widespread controversy in the field of gynecologic oncology treatment.
Both studies showed that the survival rate in the minimally invasive surgery group was lower
than that in the open surgery group.
The results of these two studies have brought unprecedented doubts and challenges to the
minimally invasive surgery for cervical cancer. The MD Anderson Cancer Center has even
stopped minimally invasive surgery for cervical cancer. Several hospitals in Hong Kong have
responded similarly. The NCCN guidelines are also quickly updated based on the results of
those studies: patients should be informed of the results of this study and doctors should
respect the patient's choices. The above research results have also attracted the attention
of many gynecological oncologists in the mainland China. Some experts questioned the design
of this study design as well as surgical skills. We need to look at these findings
cautiously. So, we launched a real-world study of clinical outcomes affected by different
surgical treatment for patients of early stage cervical cancer. We plan to recruit 2000
patients with early cervical cancer from 20-30 selected surgical centers nationwide and
perform surgery on patients with qualified and experienced doctors.We will inform the
patients current status of the study in detail, divide the patients into different
observational group according to their choices on surgical methods. The patients will be
followed up closely after surgery. We will compare the differences in clinical outcomes
between the two surgical methods and conduct subgroup and stratified analysis. We hope that
this study can truly reflect the actual status and clinical l level of early cervical cancer
treatment in China, and provide a high level of clinical evidence for the treatment of
cervical cancer in China .
The study is a non-randomized, prospective, multi-center, clinical study.Patients with early cervical cancer who were enrolled will be divided into two groups: minimally invasive surgery group (group A) and open abdominal surgery group (group B) according to the patient's choice on surgical methods.We will standardize the surgery details according to the factors that may affect the prognosis of cancer treatment in the minimally invasive surgery of cervical cancer, such as : emphasizing the tumor-free principle of surgery; using a ligation band to tighten the vagina before cutting the vagina; avoiding the use of the cup-shaped uterine manipulator;reducing frequent changes in CO2 abdominal pressure;or using a laparoscope-assist transvaginal hysterectomy and other methods to avoid the risk of tumor tissue shedding. Patients with high risk factors after surgery will receive follow-up treatment according to the 2018 NCCN guidelines. ;
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