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Not yet recruiting NCT06759480

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

Observational Locally Advanced Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laparoscopic radical hysterectomy based on space anatomy, Abdominal radical hysterectomy.
Who it may be relevant to
Registry conditions: Locally Advanced Cervical Cancer. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Procedure Laparoscopic radical hysterectomy based on space anatomy
    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.
  • Procedure Abdominal radical hysterectomy
    This producre is a classic and traditional radical hysterectomy.

Primary outcome measures

  • Overall survival [Time frame: 5 years]
  • Progression-free survival [Time frame: 5 years]
Secondary outcome measures (2)
  • Surgery complication rate [Time frame: Intraoperative or within 2 weeks after surgery]
  • Intraoperative blood loss [Time frame: Intraoperative blood loss]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06759480 · GKLW-A-2024-111-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗