QM-B and QM-C Hysterectomy for Early Cervical Cancer

Not Applicable

Recruiting

• Conditions: Uterine Cervical Neoplasms
• Interventions: Procedure: QM-B Hysterectomy; Procedure: QM-C Hysterectomy

• Registration Number: NCT04691453
• Lead Sponsor: Southern Medical University, China

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.

Study Timeline

• Study First Submitted: 2020-10-20
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31
• Study Start: 2021-01-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 538

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QM-B Hysterectomy	QM-B Hysterectomy	QM-B Hysterectomy
QM-C Hysterectomy	QM-C Hysterectomy	QM-C Hysterectomy

Primary Outcome Measures

Name	Time	Method
Rate of overall survival	5 years from surgery	Compare treatment equivalence
Rate of disease-free survival	5 years from surgery	Compare treatment equivalence

Secondary Outcome Measures

Name	Time	Method
Rate of intraoperative complications	Intra-operatively	Compare intraoperative complications between groups
Operation time	Intra-operatively	Compare operation time between groups by timer
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.
Costs	6 months from surgery	Compare costs between groups
Volume of blood loss	Intra-operatively	Compare blood loss between groups by assessment
Rate of blood transfusion	Intra-operatively	Compare rate of blood transfusion between groups
Rate of postoperative complications	6 months from surgery	Compare postoperative complications between groups
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.

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, No. 1838, Guangzhou Avenue, Guangzhou 510515; 🇨🇳 Guangzhou, Guangdong, China