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

Not yet recruiting

• Conditions: Locally Advanced Cervical Cancer

• Registration Number: NCT06759480
• Lead Sponsor: International Peace Maternity and Child Health Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-27
• Study First Submitted: 2024-12-28
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-01-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	5 years	The time from end of surgery to death from any cause.
Progression-free survival	5 years	The time from end of surgery to either the first documented disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Surgery complication rate	Intraoperative or within 2 weeks after surgery	Including the rates of ureter or bladder injury, colon injury, deep vein thrombosis event and infection.
Intraoperative blood loss	Intraoperative blood loss