NCT03739944

Different Surgical Approaches in Patients of Early-stage Cervical Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Lei Li · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Uterine Cervical Neoplasm
• Laparotomy
• Laparoscopy
• Survival
• Mortality
• Morbidity
• Quality of Life
• Pelvic Floor Disorders
• Cost-Benefit Analysis

Interventions

Type	Name	Description
PROCEDURE	Laparotomic radical hysterectomy	Laparotomic radical hysterectomy for patients without fertility requirement
PROCEDURE	Laparotomic radical trachelectomy	Laparotomic radical hysterectomy for patients with fertility requirement
PROCEDURE	Laparoscopic radical hysterectomy	Laparoscopic radical hysterectomy for patients without fertility requirement
PROCEDURE	Laparoscopic radical trachelectomy	Laparoscopic radical hysterectomy for patients with fertility requirement

Timeline

• Start date: 2018-11-23
• Primary completion: 2022-11-23
• Completion: 2023-11-23
• First posted: 2018-11-14
• Last updated: 2018-12-28

Locations

1 site across 1 country: China