RecruitingNot ApplicableNCT04929769

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)


Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

780 participants

Start Date

May 7, 2021

Study Type

INTERVENTIONAL

Conditions

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 IB1, IB2, IIA1).


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares laparoscopic (minimally invasive, keyhole) surgery to traditional open abdominal surgery for removing the uterus and surrounding tissue in cervical cancer patients at stages IB1, IB2, and IIA1. **You may be eligible if...** - You have been diagnosed with cervical cancer at stage IB1, IB2, or IIA1 - You are between 21 and 70 years old - Your blood counts and organ function (liver, kidneys) are within normal ranges - You have no history of other cancers - You are not pregnant - You are in reasonably good physical health (Karnofsky score at least 60) **You may NOT be eligible if...** - Your cancer is at a different stage than those listed - You have had a previous cancer (other than the current diagnosis) - You are pregnant - You have a psychiatric condition that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTotal Laparoscopic or Robotic Radical Hysterectomy

Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.

OTHERTotal Abdominal Radical Hysterectomy

Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.


Locations(1)

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT04929769


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