The goal of this clinical research study is to compare the long-term outcomes and safety of Querleu-Morrow-B(QM-B) and Querleu-Morrow-C(QM-C) hysterectomy for early cervical cancer. In this study, the surgical approach for QM-B and QM-C hysterectomy will be abdominal.
Primary Objective: To compare 5-year overall survival and 5-year disease-free survival amongst patients who undergo a QM-B hysterectomy versus those who undergo a QM-C hysterectomy for early stage cervical cancer. Secondary Objectives: Compare operation time between arms. Compare blood loss between arms. Compare blood transfusion between arms. Compare intraoperative complications between arms. Compare postoperative complications between arms. Compare quality of lifes between arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
538
This operation corresponds to the classical radical hysterectomy. The lateral border is defined as the medial aspect of the internal iliac artery and vein. Transection of the rectovaginal and rectouterine ligaments is performed at the rectum. Transection of the ventral parametrium ligament is performed at the bladder. Both the vesicouterine and vesicovaginal ligaments are resected. The ureter is completely mobilized and lateralized. The length of the vaginal cuff is adjusted to the vaginal extent of the tumor.
Type B is the modified radical hysterectomy. The ureter is unroofed and mobilized laterally, permitting transection of the paracervix at the level of the ureteral tunnel. Partial resection of the uterosacral peritoneal fold of the rectouterine ligament (dorsal parametrium) and the vesicouterine (ventral parametrium) ligament also is a standard component of this resection. Approximately 10 mm of the vagina from the caudal edge of the cervix or tumor is resected, without intent to radically resect the paravaginal tissues.
Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
Guangzhou, Guangdong, China
RECRUITINGRate of overall survival
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Time frame: 5 years from surgery
Rate of disease-free survival
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Time frame: 5 years from surgery
Operation time
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Time frame: Intra-operatively
Volume of blood loss
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Time frame: Intra-operatively
Rate of blood transfusion
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Time frame: Intra-operatively
Rate of intraoperative complications
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Time frame: Intra-operatively
Rate of postoperative complications
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Time frame: 6 months from surgery
Quality of life Questionnaires
Compare quality of lifes between groups by questionnaire: EORTC CX24. EORTC CX24 for symptom experience, body imageand sexual/vaginal functioning. The scores of EORTC CX24 range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame: 6 months from surgery
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Pelvic Floor Distress Inventory Questionnaire
Compare PFDI between groups by questionnaire PFDI-20. The calculation of the total scores of PFDI-20 range from 0 to 300; the higher the score the greater the perceived impact that pelvic floor dysfuntion has on a patient's life.
Time frame: 5 years from surgery
Costs
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Time frame: 6 months from surgery