gynecologic malignancies
Conditions
Interventions
Experimental group:Telerobotic gynecologic oncology surgery using the MP2000 system.
Control group:On-site robotic surgery using using the MP2000 system.
Sponsors
The Seventh Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Cervical cancer: ages 18–70; endometrial cancer: ages 18–80; female; 2. BMI: 18–40 kg/m^2; 3. Histopathologically confirmed endometrial or cervical cancer, with relevant surgical indications: (1) Enrollment criteria for cervical cancer patients: 1) Pathological type: squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2) FIGO 2018 staging: IA1 with LVSI ( ) with lymphovascular tumor thrombus ( ), IA2, IB1; (2) Enrollment criteria for endometrial cancer patients: 1) Pathological type: endometrioid carcinoma; 2) FIGO 2009 staging: Stage I, Stage II; 4. Physiological condition suitable for laparoscopic surgery; 5. Willing to cooperate and complete study follow-up and related examinations; 6. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe cardiovascular or circulatory system diseases and unable to tolerate surgery; 2. Patients who wish to preserve fertility; 3. Pregnancy or breastfeeding; 4. History of epilepsy or psychiatric disorders; 5. Severe allergies or suspected/confirmed alcohol or drug addiction; 6. Unable to understand the study requirements or unable to complete the study follow-up plan; 7. Considered by the researcher as unsuitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| surgical success rate;incidence of Grade >=3 complications;Reoperation rate (%);Mortality (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall complication rate;Operative time (minutes);Estimated intraoperative blood loss (mL);Positive surgical margin rate (%);Postoperative pain score on POD1;Surgeon satisfaction;Length of hospital stay (days);Transfusion rate (%);Readmission rate (%);Device malfunction/defect incidence;Adverse event (AE) incidence;Serious adverse event (SAE) incidence;Telesurgical operation assessment;overall survival;disease-free survival; | — |
Countries
China
Contacts
Public ContactMeng Yuanguang
The Seventh Medical Center of Chinese PLA General Hospital
Outcome results
None listed