NCT04934982

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

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 690 (estimated)
• Sponsor: Hua Jiang · Academic / Other
• Sex: Female
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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)

Detailed description

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IA1 with LVSI, IA2), by a multicenter stratified randomized controlled study, mainly including the following aspects: 1. To compare the differences in PFS and OS between patients receiving LRH and ARH. 2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. To assess postoperative complications and quality of survival.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-09-24
• Primary completion: 2024-06-01
• Completion: 2026-06-01
• First posted: 2021-06-22
• Last updated: 2021-11-10

Locations

1 site across 1 country: China