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Prospective clinical study on preoperative evaluation, operative mode selection and long-term outcome of low-risk endometrial carcinoma

Prospective clinical study on preoperative evaluation, operative mode selection and long-term outcome of low-risk endometrial carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016311
Enrollment
Unknown
Registered
2018-05-24
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial carcinoma

Interventions

experimental group:The mode of operation is Laparoscopic hysterectomy plus bilateral adnexectomy
control group:The mode of operation is Laparoscopic hysterectomy + bilateral adnexal resection + pelvic lymphadenectomy plus para aortic lymph node dissection

Sponsors

the Third Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Preoperative hysteroscopy or curettage histopathology: endometrial adenocarcinoma and tumor cell differentiation were G1-G2; 2. Blood test: tumor marker (CA125 < 35U/L); 3. Preoperative MRI images suggested that muscular infiltration was less than 1/2, no lymph node enlargement (short axis < 1cm), no extrauterine metastasis, and no cervical stromal involvement; 4. Intraoperative exploration: no suspicious lymph node metastasis; no extrauterine metastasis; 5. Hysterectomy was performed: muscular infiltration was less than 1/2, and there was no cervical interstitial involvement.

Exclusion criteria

Exclusion criteria: 1. General condition is poor, can not tolerate surgery, choose other treatment methods; 2. Preoperative evaluation revealed high risk factors, such as the following 1 items: high-risk endometrial carcinoma : The pathological grade was G3; The pathological type was non endometrioid adenocarcinoma; The depth of myometrial invasion was more than 1/2 before operation or during operation; Preoperative evaluation or intraoperative section of the uterus and cervical stromal involvement; 3. Patients with other malignant tumors (excluding skin cancer and thyroid cancer) within 5 years; 4. At the same time combined with other difficult to control serious diseases, absolute surgical contraindication; 5. Those who refuse to participate in clinical research or refuse to sign informed consent.

Design outcomes

Primary

MeasureTime frame
blood loss;Intraoperative complications;Postoperative complications;length of stay;Cost;Postoperative pathology;Relapse;Tumor free survival;progression-free survival;survival rate;Surgical complication rate;mortality;Reoperation rate;Readmission rate at 30 days after operation;Quality of life score;

Secondary

MeasureTime frame
age;Operation time;

Countries

China

Contacts

Public ContactGuangwu Xiong

the Third Affiliated Hospital of Chongqing Medical University

xiong-gw@163.com+86 13391766141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026