Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Uterine Cervical Neoplasms

Pelvic Floor Disorders

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for laparotomic radical trachelectomy