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

• Conditions: Uterine Cervical Neoplasms; Laparotomy; Recurrence; Mortality; Survival; Laparoscopy
• Interventions: Procedure: Laparoscopic radical hysterectomy; Procedure: Laparotomic radical hysterectomy

• Registration Number: NCT03738969
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Last Update Submitted: 2018-11-09
• Study Start: 2018-11-10
• Study First Posted: 2018-11-13
• Last Update Posted: 2018-11-14
• Primary Completion: 2022-12-23
• Study Completion: 2023-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopy group	Laparoscopic radical hysterectomy	Patients in this group accepted laparoscopic or robotic radical hysterectomy for cervical cancer.
Laparotomy group	Laparotomic radical hysterectomy	Patients in this group accepted laparotomic radical hysterectomy for cervical cancer.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Five years	Length of time during and after the treatment of cervical cancer, that a patient lives with the disease but it does not get worse

Secondary Outcome Measures

Name	Time	Method
Overall survival	Five years	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 a clinical trial, measuring the overall survival is one way to see how well a new treatment works.
Disease-free survival	Five years	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. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China