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Different Surgical Approaches in Patients of Early-stage Cervical Cancer

NCT03739944 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2018-12-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-23
Primary Completion
2022-11-23
Completion
2023-11-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739944 on ClinicalTrials.gov