An observational study in Locally Advanced Cervical Cancer, sponsored by International Peace Maternity and Child Health Hospital. Not yet recruiting. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by International Peace Maternity and Child Health Hospital · Observational
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 500 is above the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →International Peace Maternity and Child Health Hospital is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
In this group, patients received a modified laparoscopic radical hysterectomy(LRH) based on space antomy.
Procedure: Laparoscopic radical hysterectomy based on space anatomy
In this group, patients received a traditional abdominal radical hysterectomy(ARH). ARH group is defined as a control group.
Procedure: Abdominal radical hysterectomy
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.
This producre is a classic and traditional radical hysterectomy.
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
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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International Peace Maternity and Child Health Hospital