Health Condition 1: K00-K95- Diseases of the digestive system Health Condition 2: E65-E68- Overweight, obesity and other hyperalimentation
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: BMR-5000 Surgical Robot: The main system includes Surgical Cart, Control Console, Lens Drive Robot, Tool Drive Robot, and Equipment Cabinet. The main system oper
Sponsors
Max Hospital Vaishali
Borns Medical Robotics Inc
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet the surgical indications and need minimally invasive cholecystectomy, appendectomy, abdominal hernia repair, bariatric or gastrointestinal surgery.Volunteered to participate in this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who cannot tolerate or establish pneumoperitoneum. 2. Severe heart, lung, liver, and kidney disease who cannot tolerate surgery. 3. Those who need emergency surgery due to illness. 4. History of continuous systemic corticosteroid or immunosuppressive therapy within the past 1 mon. 5. The patient is mentally incapable to understand the requirements and consequences of the study. 6. Pregnant and lactating women. 7. The patient is unwilling or unable to comply with the doctor orders. 8. Those who have participated in clinical trials within the past three months. 9. Extremes of age (Less than 18 years or more than 75 years) 10. Other conditions deemed inappropriate by the PI and medical staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, serious adverse events, and complications (i.e., surgery-related adverse events, device defects) Surgical success rate, which is the rate between the cases completed without unplanned change in surgical treatment (such as conversion to conventional laparoscopic /open surgery) and the total number of cases.Timepoint: Before surgery (Day -30) Operation period (Day 0) 24 hours after surgery Postoperative (Day 3) Postoperative (Day 7) After surgery (Day 14) Postoperative (Day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| operation time, intraoperative blood loss, device performance, physical status score (ECOG), cost analysis, etc.Timepoint: Operation period (Day 0) 24 hours after surgery Postoperative (Day 3) Postoperative (Day 7) After surgery (Day 14) Postoperative (Day 30) | — |
Countries
India
Contacts
Public ContactPawan Sharma
Max Super Speciality Hospital Vaishali
Outcome results
None listed