Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06759480

Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer

Radical hysterectomy is an effect treatment for FIGO IB3 and IIA2 cervical cancer patients who refuse to receive radical concurrent chemoradiotherapy. However, due to the large tumor size, both patients and surgeons encountered the risk of substantial bleeding, urinary tract damage, and unsatisfactory resection during surgery. Therefore, the exploration of effective and safe surgical treatments is crucial in enhancing the quality of life and prognosis for patients. Laparoscopic radical hysterectomy (LRH) offers the advantages of reduced bleeding and accelerated recovery, thereby minimizing patient discomfort and enhancing their quality of life. However, the prognosis of patients who received LRH or traditional abdominal radical hysterectomy (ARH) remains controversial. We proposed a modified LRH skill based on new space anatomy concept. In our previous single-center study, the result demonstrates that LRH based on space anatomy leads to less intraoperative blood loss and decreased ureteral injury rate compared with traditional skill. The benefits of this new method for patient survival remain uncertain. In this multicenter retrospective study, we aim to assess clinical prognosis and safety of this new LRH compared with traditional abdominal radical hysterectomy (ARH) in FIGO IB3 and IIA2 cervical cancer.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 20 to 70 years
  • Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer;
  • Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy;
  • no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement.

Exclusion criteria

  • patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis;
  • pregnancy;
  • incomplete radical surgery;
  • follow-up time less than 6 months or lost to follow-up

Treatment and study plan

Laparoscopic radical hysterectomy based on space anatomy

Procedure

This is a modified laparoscopic radical hysterectomy based on space anatomy. By identifying the vesicouterine ligament and four associated special spaces, the ureter can be completely liberated from the external aspect of the uterus. This skill not only reduces rate of surgical complications but also facilitates optimal tumor resection.

Abdominal radical hysterectomy

Procedure

This producre is a classic and traditional radical hysterectomy.

Primary outcomes

  1. Overall survival

    Time frame: 5 years

    The time from end of surgery to death from any cause.

  2. Progression-free survival

    Time frame: 5 years

    The time from end of surgery to either the first documented disease progression or death from any cause.

Secondary outcomes

  1. Surgery complication rate

    Time frame: Intraoperative or within 2 weeks after surgery

    Including the rates of ureter or bladder injury, colon injury, deep vein thrombosis event and infection.

  2. Intraoperative blood loss

    Time frame: Intraoperative blood loss

Study contacts

Contact information is provided by the study sponsor or research team.

Sibang Chen

CONTACT

[email protected]

+86 18721757863

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study title

Comparison Between Laparoscopic Radical Hysterectomy Based on Space Anatomy and Abdominal Radical Hysterectomy for Stage IB3 and IIA2 Cervical Cancer: a Multicenter Retrospective Cohort Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.