Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

The patients will receive laparoscopic or robotic assisted radical hysterectomy with improved surgery details: 1) Uterine manipulator type Cup-shaped uterine manipulator is prohibited, uterus hanging wire is allowed. 2) Avoid tumor cells shedding into the pelvis: A. Cut the vagina with the transvaginal method, B. Cut the vagina after closed loop ligation of the vagina. After the surgery, they will receive adjuvant therapy according to the pathological risk factors refer to the 2018 NCCN guidelines.

The patients will receive traditional radical hysterectomy.After the surgery, they will receive adjuvant therapy according to the pathological risk factors refer to the 2018 NCCN guidelines.

Laparoscopic or robotic assisted radical hysterectomy

minimally invasive surgery

Traditional open abdominal radical hysterectomy

open abdominal surgery

Ding Ma, MD;PHD

Ding Ma, MD,PHD

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.

Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer

Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer, A Multicenter, Prospective and Non-Randomized Controlled Trial

The individual participants data will be preserved in the hospital, and all the chemical or physical examination results will be kept in the medical records, the researches, ethics committee and the drug administration will be permitted to look up all the records as we planned. And all the reports or papers about this research will not relate to the patients' identity. But we do not decide whether the information be available to others, the final decision maybe decided by all the patients in this research.

DFS was definite as the time from surgery to disease recurrence

OS was defined as time from surgery to death by any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer	NCT03955185	Uterine Cervica...	minimally invas... open abdominal ...	18 Years - 65 Years	Huazhong University of Science and Technology
Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer	NCT03955185	Uterine Cervica...	minimally invas... open abdominal ...	18 Years - 65 Years	Huazhong University of Science and Technology

Spots Global Cancer Trial Database for open abdominal surgery