About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients who clinically diagnosed with IB3 and IIA2 cervical cancer are retrospectively collected from electronic medical records of four tertiary medical center from January 2012 to January 2022
Trial design
Cohort
Retrospective
Treatments tested in this trial
Laparoscopic radical hysterectomy based on space anatomy
Procedure/SurgeryThis 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/SurgeryThis producre is a classic and traditional radical hysterectomy.
Treatment groups
Trial outcomes
Primary outcomes
Overall survival
The time from end of surgery to death from any cause.
Progression-free survival
The time from end of surgery to either the first documented disease progression or death from any cause.
Secondary outcomes
Surgery complication rate
Including the rates of ureter or bladder injury, colon injury, deep vein thrombosis event and infection.
Intraoperative blood loss
Locations
Sponsors and contacts
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