Uterine Cervical Neoplasms
Conditions
Keywords
Cervical cancer, QM-B, QM-C, Oncology outcome, Safety, Hysterectomy, Radical Hysterectomy, Abdominal
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREQM-C 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.
PROCEDUREQM-B 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.
Sponsors
Southern Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have signed an approved Informed Consent * 18.5≤BMI\<28 * Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix; * Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, stage IB1, stage IB2, or stage IIA1 disease(FIGO 2018). * Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1. * Patients undergoing the Non-Fertility-Sparing surgery. * Patients undergoing abdominal surgery.
Exclusion criteria
* The life expectancy of the patient is less than 6 months. * Patients with serious medical diseases. * Patients with contraindications to surgery or anesthesia. * Preoperative imaging studies suggest metastasis to pelvic lymph nodes or para-aortic lymph nodes. * Patient asks to preserve fertility. * The patient requested direct radiation therapy. * Patients with adjuvant radiotherapy or chemotherapy before surgery. * Patients judged by the investigator to be unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall survival | 5 years from surgery | Compare treatment equivalence |
| Rate of disease-free survival | 5 years from surgery | Compare treatment equivalence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of blood transfusion | Intra-operatively | Compare rate of blood transfusion between groups |
| Rate of intraoperative complications | Intra-operatively | Compare intraoperative complications between groups |
| Rate of postoperative complications | 6 months from surgery | Compare postoperative complications between groups |
| Operation time | Intra-operatively | Compare operation time between groups by timer |
| Pelvic Floor Distress Inventory Questionnaire | 5 years from surgery | 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. |
| Costs | 6 months from surgery | Compare costs between groups |
| Quality of life Questionnaires | 6 months from surgery | 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. |
| Volume of blood loss | Intra-operatively | Compare blood loss between groups by assessment |
Countries
China
Contacts
Primary ContactChunlin Chen, Doctor
Outcome results
None listed