Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer

Lei Li

Status: Unknown

Conditions: Mortality; Laparotomy; Uterine Cervical Neoplasms; Survival; Laparoscopy; Recurrence

Treatments: Procedure: Laparoscopic radical hysterectomy; Procedure: Laparotomic radical hysterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03738969

SACCC

Details and patient eligibility

About

This multi-center longitudinal study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between uterine cervical patients receiving different surgical routes (vaginal, laparotomy and laparoscopy), which is the primary study objective. All clinical and pathological data would be retracted from case reviews, and all survival data would be reached by clinic, telephone and mail follow-up. This study also would analyze the impact on survival outcomes of other factors, including nerve-sparing techniques, neoadjuvant chemotherapy, neoadjuvant radiotherapy and infection of human papillomavirus. The predictive effects of different following protocol and imaging plans will be also compared. Last, the influences of surgical routes on the fertility outcomes (pregnancy and its complications) and the ovarian reserve are important secondary study objectives.

Enrollment: 3,000 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathological confirmed as uterine cervical cancer
• Having definite clinical information
• Having received radical hysterectomy or trachelectomy

Exclusion criteria

• Not satisfying any of the inclusion criteria

Trial design

3,000 participants in 2 patient groups

Laparotomy group

Description:

Patients in this group accepted laparotomic radical hysterectomy for cervical cancer.

Treatment:

Procedure: Laparotomic radical hysterectomy

Laparoscopy group

Description:

Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer.

Treatment:

Procedure: Laparoscopic radical hysterectomy