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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    538
  • sponsor
    Southern Medical University, China
Updated on 29 January 2021

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.

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.

Details
Condition Cervical Cancer, Cervical Cancer, Disorders of cervix NOS, Uterine Cancer, Uterine Cancer, cervical neoplasm
Treatment QM-C Hysterectomy, QM-B Hysterectomy
Clinical Study IdentifierNCT04691453
SponsorSouthern Medical University, China
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have signed an approved Informed Consent
5BMI<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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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