An interventional study of QM-C Hysterectomy and QM-B Hysterectomy in Uterine Cervical Neoplasms, sponsored by Southern Medical University, China. Status unknown at 1 site in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-12-31.
Sponsored by Southern Medical University, China · Not applicable, Interventional, and Treatment
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.
1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.
This study's planned enrollment of 538 is above the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Southern Medical University, China is the lead sponsor of 31 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
QM-C Hysterectomy
Procedure: QM-C Hysterectomy
QM-B Hysterectomy
Procedure: QM-B Hysterectomy
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.
Also known as: Type III radical hysterectomy, Radical hysterectomy, Type C radical hysterectomy
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.
Also known as: Type II radical hysterectomy, Modified radical hysterectomy, Type B radical hysterectomy
Rate of overall survival
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Time frame: 5 years from surgery
Rate of disease-free survival
Compare treatment equivalence
Time frame: 5 years from surgery
Operation time
Compare operation time between groups by timer
Time frame: Intra-operatively
Volume of blood loss
Compare blood loss between groups by assessment
Time frame: Intra-operatively
Rate of blood transfusion
Compare rate of blood transfusion between groups
Time frame: Intra-operatively
Rate of intraoperative complications
Compare intraoperative complications between groups
Time frame: Intra-operatively
Rate of postoperative complications
Compare postoperative complications between groups
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
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
Plan to share: No
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This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Southern Medical University, China