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

NCT04691453UNKNOWNNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Southern Medical University, China

Enrollment

538

Start Date

2021-01-01

Completion Date

2025-01-01

Study Type

INTERVENTIONAL

Official Title

Randomized Clinical Trial Comparing the Oncology Outcome and Safety of QM-B and QM-C Hysterectomy for Early Cervical Cancer

Interventions

QM-C HysterectomyQM-B Hysterectomy

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Rate of overall survival

Compare treatment equivalence

Time frame: 5 years from surgery

Rate of disease-free survival

Compare treatment equivalence

Time frame: 5 years from surgery

Secondary Outcomes

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

Compare costs between groups

Time frame: 6 months from surgery

Locations

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

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

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