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A prospective, multicenter, single-arm study evaluating the safety and efficacy of endoscopic surgical systems for general surgery

A prospective, multicenter, single-arm study evaluating the safety and efficacy of endoscopic surgical systems for general surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078133
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-03-29
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

General surgery

Interventions

Experimental group:endoscopic surgical robotic system

Sponsors

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine (North Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age= 18 years old = 75 years old, and gender is not limited; 2. Minimally invasive gastrectomy (radical gastrectomy, partial gastrectomy), bowel resection (radical colorectal resection) and cholecystectomy are planned; 3. For gastric cancer patients, it is necessary to meet: (1) primary gastric cancer stage I./II./III.; (2) Clinical and imaging examinations without distant metastases such as liver or lungs; 4. For colorectal cancer patients, preoperative diagnosis is required for stage I./II./III. colorectal cancer; 5. Patients fully understand the benefits and risks of this trial, and are willing to participate in this trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have severe heart, lung, brain, liver and kidney diseases, unable to tolerate surgery or anesthesia; 2. Inability to tolerate pneumoperitoneum; 3. Severe anemia, coagulation dysfunction; 4. Patients with active tuberculosis; 5. Extensive metastasis in the abdomen-pelvic cavity of the tumor; 6. Colorectal cancer obstruction with obvious abdominal distention; 7. Emergency surgery such as acute obstruction, perforation, and heavy bleeding of tumors; 8. Tumor perforation combined with acute peritonitis; 9. Extensive and severe adhesions in the abdominal cavity, etc., resulting in the inability to puncture to establish pneumoperitoneum, and difficult to separate the storm exposed lesions; Includes history of major abdominal surgery and abdominal radiotherapy, as judged by the investigator Situations where there is a risk of extensive adhesions; 10. Physical failure, massive abdominal effusion, internal bleeding or shock; 11. Gastric cancer lymph node metastases fuse and enclose important blood vessels; 12. Pregnant and lactating women; 13. Severe obesity with BMI = 30 kg/m2; 14. Those with a history of epilepsy or psychiatric illness or cognitive impairment; 15. Participated in clinical trials of other drugs or devices within 3 months before surgery; 16. Other conditions deemed unsuitable by the investigator to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Secondary

MeasureTime frame
Blood loss;Operation time;Hospital stays;Postoperation pain score;Surgeon's satisfaction socre ;Blood transfusion rate;

Countries

China

Contacts

Public ContactZhao Ren

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

1217909635@qq.com+86 25 8680 2480

Outcome results

None listed

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