Health Condition 1: K929- Disease of digestive system, unspecified
Conditions
Interventions
Intervention1: BMR-5000 Surgical Robot: The main system includes
Surgical Cart, Control Console,
Lens Drive Robot, Tool Drive
Robot, and Equipment Cabinet.
The main system operates the
robotic instrum
Sponsors
Devki Devi Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1) Age 18 to 75 years (including 18 and 75 years). 2) Gender is not limited. 3) Patients who meet the indications for general surgery and are planned for laparoscopic/ endoscopic gastro-intestinal surgery, bariatric surgery, hepatobiliary surgery, splenic surgery, abdominal hernia repair are included in the study. Cholecystectomy/ CBD exploration Ventral and inguinal hernia repair Solid organ surgery (liver, spleen, adrenal) Sleeve gastrectomy 4) Volunteered to participate in this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Those who cannot tolerate or have established pneumoperitoneum. 2) Lymph node metastases fused and surrounded by important blood vessels. 3) Patients with extensive infiltration of tumor and surrounding tissues are not suitable for minimally invasive surgery. 4.Those with poor general condition that cannot be corrected despite preoperative treatment. 5.Severe heart, lung, liver, and kidney disease who cannot tolerate surgery. 6.Those who need emergency surgery due to illness. 7.History of continuous systemic corticosteroid or immunosuppressive therapy within the past 1 month. 8.The patient is mentally incapable or unable to understand the requirements of participating in the study. 9.Pregnant and lactating women. 10.The patient isunwilling or unable to comply with the doctors orders. 11. Those who have participated in clinical trials within the past three months 12.Other conditions deemed inappropriate by the PI and medical staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of complications related to the test device that meet the Clavien Dindo grading system level III a or higher criteria from the first incision to 14 or 30 days after surgery depending on the type of surgery. Timepoint: Visit 1 Screening Period Visit 2 Operation Period (Day 0). Visit 3 24 hours after surgery. Visit 4: postoperative follow-up (day 7±2) on-site or by phone. Visit 5: postoperative follow-up (Group A: day 14±2, Group B: day 30±5). | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary endpoints of the study will encompass the following parameters: Surgical times, blood loss during intraoperative procedures, performance of the device along with the overall function & stability. Timepoint: Visit 1 Screening Period Visit 2 Operation Period (Day 0). Visit 3 24 hours after surgery. Visit 4: postoperative follow-up (day 7±2) on-site or by phone. Visit 5: postoperative follow-up (Group A: day 14±2, Group B: day 30±5). | — |
Countries
India
Contacts
Public ContactDr Vivek Bindal
Max Super Speciality Hospital Vaishali
Outcome results
None listed