Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
538 participants
INTERVENTIONAL
2021-01-01
2025-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QM-C Hysterectomy
QM-C Hysterectomy
QM-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.
QM-B Hysterectomy
QM-B Hysterectomy
QM-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.
Interventions
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QM-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.
QM-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
FEMALE
No
Sponsors
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Southern Medical University, China
OTHER
Responsible Party
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Chen Chunlin
Director, Head of Obstetrics and Gynecology, Principal Investigator, Clinical Professor
Principal Investigators
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Chunlin Chen, Doctor
Role: STUDY_CHAIR
Nanfang Hospital, Southern Medical University
Locations
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Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Chunlin Chen, Doctor
Role: primary
Other Identifiers
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NFEC-2020-175
Identifier Type: -
Identifier Source: org_study_id