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

N/ANot Yet RecruitingNCT06759480

International Peace Maternity and Child Health Hospital500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Locally Advanced Cervical Cancer

Interventions

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 20 to 70 years 2. Preoperative clinical diagnosis was FIGO 2018 stage IB3 or IIA2 cervical cancer; 3. Patients who received standard Querleu-Morrow type C radical hysterectomy (including ARH or LRH based on space anatomy) and pelvic lymphadenectomy; 4. no preoperative suspected lymph nodes metastasis, parametrial involvement or lower 1/3 vagina involvement. Exclusion Criteria: 1. patients who had active double cancer or uncontrolled serious concurrent disease that might compromise prognosis; 2. pregnancy; 3. incomplete radical surgery; 4. follow-up time less than 6 months or lost to follow-up

Outcomes

Primary Outcomes

Overall survival

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

Time frame: 5 years

Progression-free survival

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

Time frame: 5 years

Secondary Outcomes

Surgery complication rate

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

Time frame: Intraoperative or within 2 weeks after surgery

Intraoperative blood loss

Time frame: Intraoperative blood loss