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A Clinical Study Evaluating the Safety and Efficacy of a Modular Surgical Robot in Laparoscopic Partial Gastrectomy

A Clinical Study Evaluating the Safety and Efficacy of a Modular Surgical Robot in Laparoscopic Partial Gastrectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108713
Enrollment
Unknown
Registered
2025-09-03
Start date
2025-09-15
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Gastric Cancer

Interventions

Intervention Group:Modular Robotic Surgery

Sponsors

Renji Hospital ,Shanghai Jiaotong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Participants must meet all of the following inclusion criteria: 1. Age between 18 and 80 years, regardless of sex; 2. Histologically and/or cytologically confirmed gastric tumor amenable to partial gastrectomy with curative intent; 3. Willingness to participate in this study and voluntary signing of informed consent; 4. Willingness and good compliance to complete study follow-up and related examinations; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 6. Absence of distant metastasis confirmed by preoperative chest-abdomen-pelvis CT or PET-CT.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they meet any of the following criteria: 1. Body mass index (BMI) =35 kg/m²; 2. Presence of severe cardiac, pulmonary, cerebral, hepatic, or renal disease rendering the patient unable to tolerate surgery or anesthesia; 3. Inability to tolerate pneumoperitoneum, or, in the investigator’s judgment, presence of extensive or severe intra-abdominal adhesions posing high risk for trocar insertion and establishment of pneumoperitoneum; 4. Severe coagulation disorders precluding tolerance of laparoscopic surgery; 5. Active pulmonary tuberculosis; 6. Presence of severe uncontrolled disease or acute infection; physical failure, massive ascites, intra-abdominal hemorrhage, or shock; 7. Lymph node metastasis from gastric cancer with conglomeration and encasement of major blood vessels; 8. History of abdominal or pelvic surgery, radiotherapy, or chemotherapy deemed unsuitable for laparoscopic surgery; 9. Pregnant or breastfeeding women; 10. Participation in other clinical trials involving investigational drugs or medical devices; 11. Any condition that, in the opinion of the investigator, renders the patient unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
rate of non-conversion to open surgery;Incidence of Perioperative Complications;

Secondary

MeasureTime frame
robotic system setup time;Robot-Assisted Operative Time;Evaluation of Instrument Performance;Evaluation of Intraoperative Physiological Workload of the Primary Surgeon;Evaluation of the Primary Surgeon’s Intraoperative Cognitive Workload;Time to First Postoperative Flatus;Postoperative Pain Score;

Countries

China

Contacts

Public ContactWang Zhen, Zhang Zizhen

Renji Hospital, Shanghai Jiao Tong University School of Medicine

zhangzizhen@renji.com+86 139 1787 9569

Outcome results

None listed

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