Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer

Study Overview
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Brief Summary
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The purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary complications.

Detailed Description
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The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). The anterior leaf of the VUL in the type C resection group was sent to pathological biopsy separately, and the metastasis rate was further clarified by the pathological ultrastaging method. By comparing the clinicopathological characteristics of patients with metastasis and non-metastasis, the potential risk factors of VUL metastasis were analyzed. The oncological outcomes of patients with different resection range of the anterior VUL were compared. At the same time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table was used to evaluate cervical cancer patients after surgery. The relevant factors that may affect the quality of life score are included in the multiple linear regression analysis to obtain independent risk factors that affect the quality of life of the patient after surgery.

Official Title
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Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma) Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis Stage IA2-IIA2 ( FIGO 2018) Treated initially or just underwent cervical conization before Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team Underwent the bilateral type C AL-VUL resection during the surgery The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Not stage IA2-IIA2 ( FIGO 2018) History of abdominal or pelvic radiotherapy Evidence of metastatic disease detected by PECT, MRI or CT The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery Patients with other mailgnant tumors except cervical cancer Incompetence of the clinical, surgical and pathological data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type B resection<br>The patients reviced type B resection of the antierior leaf of vesicouterine ligament | Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)<br>* The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter).<br>|
| Type C resection<br>The patients reviced type C resection of the antierior leaf of vesicouterine ligament | Procedure: Type B resection or type C resection of the anterior leaf of vesicouterine ligament during the radical hysterectomy (type C)<br>* The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metastatic rate of the anterior leaf of vesicouterine ligament | The metastasis rate of anterior leaf of VUL (%) = (case number of positive metastatic lesion detected by H&E staining + case number of positive metastatic lesion diagnosed by ultrastaging) / Total number of the patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the samesurgical team ×100% | 1 year (Postoperative pathological confirmation date) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL | Clinical data | 1 year after surgery | 
| Incidence of postoperative urinary dysfunction in two groups | Follow-up and subjective description | 1 year after surgery | 
| Postoperative quality of life scores in two groups | The Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table | 1，2，3 years after surgery | 
| DFS | Disease-free survival | 3 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer, Radical hysterectomy, Ultrastaging, Vesicouterine ligament