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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QM-C Hysterectomy | Active Comparator | QM-C Hysterectomy |
|
| QM-B Hysterectomy | Experimental | QM-B Hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QM-C Hysterectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall survival | Compare treatment equivalence | 5 years from surgery |
| Rate of disease-free survival | Compare treatment equivalence | 5 years from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Compare operation time between groups by timer | Intra-operatively |
| Volume of blood loss | Compare blood loss between groups by assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlin Chen, Doctor | Contact | 008613725263051 | jieru@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunlin Chen, Doctor | Nanfang Hospital, Southern Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515 | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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|
|
| QM-B Hysterectomy | Procedure | 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. |
|
|
| Intra-operatively |
| Rate of blood transfusion | Compare rate of blood transfusion between groups | Intra-operatively |
| Rate of intraoperative complications | Compare intraoperative complications between groups | Intra-operatively |
| Rate of postoperative complications | Compare postoperative complications between groups | 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. | 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. | 5 years from surgery |
| Costs | Compare costs between groups | 6 months from surgery |
|
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |