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Safety and effectiveness of domestic single-hole robotic surgical system for abdominal surgery in pediatric surgery

Safety and effectiveness of domestic single-hole robotic surgical system for abdominal surgery in pediatric surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076351
Enrollment
Unknown
Registered
2023-10-06
Start date
2023-10-06
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

Abdominal diseases in children

Interventions

Sponsors

Guangzhou Women and Children Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Under 18 years old, above 1 year old, height 74cm or above. 2. Abdominal surgery is required, including but not limited to radical choledochal cyst resection, cholecystectomy, splenectomy, abdominal mass resection, enterectomy enterostomy, appendectomy and other pediatric surgical abdominal surgery. 3. Patients classified as Class I-III by the American Society of Anesthesiologists (ASA) Physical Status Classification system. 4. Be able to cooperate with the plan to complete the visit and related inspection. 5. The subject voluntarily participates in the clinical trial and agrees or the guardian agrees to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients in need of emergency surgical intervention; Anaesthesia assessment of patients who cannot tolerate pneumoperitoneum 2. There is a history of other underlying diseases and the investigator considers it unsuitable for inclusion in this study. 3. Patients who had previously received other abdominal surgery and were assessed by the investigators as unfit to participate in this study. 4. HIV antibody positive; Hepatitis B surface antigen (HbsAg) positive and hepatitis B virus DNA (HBV-DNA) copy number higher than the lower limit of detection or normal range; Hepatitis C virus (HCV) antibody positive; Patients who are antibody positive for treponema pallidum and have been judged by researchers to be at greater risk of infection. 5. Patients with serious systemic diseases who are judged by researchers to be unsuitable for surgical treatment. 6. Long-term use of anticoagulant and antiplatelet drugs (antiplatelet aggregation drugs stopped less than 1 week before surgery), with a history of hemorrhagic disease or hematopoietic dysfunction or coagulation dysfunction. 7. People with severe allergies and suspected or confirmed addiction to alcohol, drugs or drugs. 8. Patients with a history of epilepsy or mental illness or cognitive impairment. 9. Those who are participating in other interventional clinical trials. 10. Other conditions that the investigator considers inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Success rate of operation;

Secondary

MeasureTime frame
Complication rate;

Countries

China

Contacts

Public ContactWen zhe

Guangzhou Women and Children Medical Center

wenzhe2005@163.com+86 136 3230 1880

Outcome results

None listed

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