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A prospective, multicenter, randomized, single-blind, parallel-controlled study to evaluate the efficacy and safety of laparoscopic surgical equipment in clinical practice

A prospective, multicenter, randomized, single-blind, parallel-controlled study to evaluate the efficacy and safety of laparoscopic surgical equipment in clinical practice

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063848
Enrollment
Unknown
Registered
2022-09-19
Start date
2022-09-19
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Total hysterectomy ± bilateral adnexectomy ± lymph node resection

Interventions

Experimental group:Subjects in the experimental group were operated with WG-NST600T
Control group:Control subjects underwent surgery using an endoscopic surgical instrument control system made by Intuitive Surgical.

Sponsors

The First Affiliated Hospital of Xi 'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75, female; 2. Body mass index (BMI) within 18-30 Kg/m2; 3. Patients who were evaluated by the investigator for total hysterectomy, bilateral adnexectomy and lymphadenectomy; 4. The patient fully understands the benefits and risks of the study and is willing to participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Metastatic tumor or other kinds of malignant tumor other than gynecological tumor; 2. Serious and uncontrolled disease or acute infection; 3. Patients with cardiovascular and cerebrovascular diseases, blood system diseases or poor blood sugar and blood pressure control, who are unable to tolerate anesthesia or increase the risk of surgery as assessed by doctors; 4. The patient has drug abuse, epilepsy, schizophrenia, dementia and other problems, and the researcher determines that the patient cannot complete the test according to the research plan; 5. Women who planned their families, or were breastfeeding or pregnant during the entire clinical study period; 6. Patients who have participated or are participating in clinical studies of other drugs, biological agents or medical devices in the last 3 months; 7. Other conditions considered unsuitable for participation in this study by the researcher.

Design outcomes

Primary

MeasureTime frame
Achievement ratio of operation;

Secondary

MeasureTime frame
Operation time, system setup time, operation time (unit: min);Intraoperative blood loss;Postoperative hospital stay;Assessment of operator's physiological load;Mental stress assessment of surgeon;Instrument satisfaction evaluation;

Countries

China

Contacts

Public ContactRuifang An

The First Affiliated Hospital of Xi 'an Jiaotong University

xinyuanyang2022@163.com+86 18991232090

Outcome results

None listed

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