Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)

NCT04934982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 690

Last updated 2021-11-10

No results posted yet for this study

Summary

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IA1 with LVSI, IA2)

Conditions

Interventions

OTHER

Total Laparoscopic or Robotic Radical Hysterectomy

Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\~2 cm of the parametrium and 1\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).

OTHER

Total Abdominal Radical Hysterectomy

Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1\~2 cm of the parametrium and 1\~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    collaborator OTHER
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Shanghai Zhongshan Hospital

    collaborator OTHER
  • RenJi Hospital

    collaborator OTHER
  • Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences

    collaborator UNKNOWN
  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Hua Jiang

    lead OTHER

Principal Investigators

  • Hua Jiang, PHD · The Obstetrics and Gynecology Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2024-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

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 NCT04934982 on ClinicalTrials.gov