Borns Robotic Surgery System Clinical Study
- Conditions
- Health Condition 1: K00-K95- Diseases of the digestive systemHealth Condition 2: E65-E68- Overweight, obesity and other hyperalimentation
- Registration Number
- CTRI/2023/03/050470
- Lead Sponsor
- Max Hospital Vaishali
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events, serious adverse events, and complications (i.e., surgery-related adverse events, device defects) <br/ ><br> <br/ ><br>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) <br/ ><br>Operation period (Day 0) <br/ ><br>24 hours after surgery <br/ ><br>Postoperative (Day 3) <br/ ><br>Postoperative (Day 7) <br/ ><br>After surgery (Day 14) <br/ ><br>Postoperative (Day 30)
- Secondary Outcome Measures
Name Time Method operation time, intraoperative blood loss, device performance, physical status score (ECOG), cost analysis, etc.Timepoint: Operation period (Day 0) <br/ ><br>24 hours after surgery <br/ ><br>Postoperative (Day 3) <br/ ><br>Postoperative (Day 7) <br/ ><br>After surgery (Day 14) <br/ ><br>Postoperative (Day 30)