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

Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.

Total Laparoscopic or Robotic Radical Hysterectomy

Total Abdominal Radical Hysterectomy

Hua Jiang, PHD

Xin Wu, PHD

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB3, IIA2), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
3. To assess postoperative complications and quality of survival.

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

Compare these between groups(The continuous outcomes include operative duration(min), anesthesia time(min), blood loss during operation(ml), postoperative pain score and postoperative hospital stay(day). The outcomes with normal distribution will be summarised using mean and standard deviation (SD), while the outcomes with non-normal distribution will be summarised using median and interquartile. The differences in the outcomes and 95% CIs will be analysed by generalised linear model (GLM) with treatment as fixed effect and with normal distribution and identity link function.)

Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event. The differences in the outcomes and 95% CIs will be analysed by GLM with treatment as fixed effect and with binomial distribution and identity link function.)

Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups.

Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)

The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.

Children's Hospital of Fudan University

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai Zhongshan Hospital

RenJi Hospital

Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences

First Affiliated Hospital of Wenzhou Medical University

Obstetrics & Gynecology Hospital of Fudan University

Behaviors and Mental Disorders

Pelvic Floor Disorders

Male Urogenital Diseases

Quality of Life

Laparotomic radical hysterectomy for patients without fertility requirement

Laparotomic radical hysterectomy

Laparotomic radical hysterectomy for patients with fertility requirement

Laparotomic radical trachelectomy

Laparoscopic radical hysterectomy for patients without fertility requirement

Laparoscopic radical hysterectomy

Laparoscopic radical hysterectomy for patients with fertility requirement

Laparoscopic radical trachelectomy

Lei Li, M.D.

Lei Li, MD

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.

Different Surgical Approaches in Patients of Early-stage Cervical Cancer

Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer

The data will be available to all the researches via public websites.

The direct cost of different surgical routes

The quality of life measured by academic questionnaire

Sex function measured by academic questionnaire before and after surgeries

Urinary functions are measured by dynamic tests before and after surgeries

Rectal functions are measured by dynamic tests before and after surgeries

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.

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 cancer, the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

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

Lei Li

Professor

Jiang Hua, PHD

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
3. To assess postoperative complications and quality of survival.

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

Compare these between groups(The continuous outcomes include operative duration, anesthesia time, blood loss during operation, postoperative pain score and postoperative hospital stay.)

Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event.)

Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.

Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\~2 cm of the parametrium and 1\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IA1 with LVSI, IA2)

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IA1 with LVSI, IA2), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
3. To assess postoperative complications and quality of survival.

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)	NCT04939831	Cervical Cancer	Total Laparosco... Total Abdominal...	21 Years - 70 Years	Obstetrics & Gynecology Hospital of Fudan University
Different Surgical Approaches in Patients of Early-stage Cervical Cancer	NCT03739944	Uterine Cervica... Laparotomy Laparoscopy Survival Mortality Morbidity Quality of Life Pelvic Floor Di... Cost-Benefit An...	Laparotomic rad... Laparotomic rad... Laparoscopic ra... Laparoscopic ra...	18 Years -	Peking Union Medical College Hospital
Different Surgical Approaches in Patients of Early-stage Cervical Cancer	NCT03739944	Uterine Cervica... Laparotomy Laparoscopy Survival Mortality Morbidity Quality of Life Pelvic Floor Di... Cost-Benefit An...	Laparotomic rad... Laparotomic rad... Laparoscopic ra... Laparoscopic ra...	18 Years -	Peking Union Medical College Hospital
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)	NCT04929769	Cervical Cancer	Total Laparosco... Total Abdominal...	21 Years - 70 Years	Obstetrics & Gynecology Hospital of Fudan University
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)	NCT04934982	Cervical Cancer	Total Laparosco... Total Abdominal...	21 Years - 70 Years	Obstetrics & Gynecology Hospital of Fudan University

Spots Global Cancer Trial Database for laparoscopic radical hysterectomy