Appendicitis, Cholecystolithiasis, Colon Cancer, Gastric Bypass, Gastric Cancer, Gastric Ulcer With Perforation But Without Obstruction, Rectal Cancer, Sleeve Gastrectomy
Conditions
Brief summary
Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named Micro Hand S in 2013. Recently, as the domestic surgical robot research project's main section, this new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University.
Detailed description
One surgeon perform these surgical trials using the robot Micro Hand S. All of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. In addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.
Interventions
PROCEDUREMicro Hand S robotic surgery
20-70 patients undergo Micro Hand S robotic surgeries
PROCEDURElaparoscopic surgery
20-70 patients undergo laparoscopic surgeries
PROCEDUREda Vinci robotic surgery
20-70 patients undergo da Vinci robotic surgeries
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively * 18years\<age\<65years * male or female
Exclusion criteria
* patients with a history of open abdominal surgery * unstable psychiatric illness * an inability or reluctance to cooperate during long-term follow-up * alcohol or drug addiction * or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complication | within 30 days after surgery | type of complication/grade of complication |
| intraoperative outcomes | up to 1 week after operation | surgical procedure/operative time/console time/blood loss/conversion |
| postoperative outcomes | up to 1 month after operation | Time to first flatus/intake/hospital stay |
| pathological outcomes | up to 1 month after operation | resection margin/harvested lymph node/mesorectal grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| functional outcomes | at least12 months after operation | wexner/ipss/iief score |
| recurrence | at least 12 months after operation | local recurrence and metastasis |
| survival | at least 12 months yesra after operation | disease free survival/overall survival |
| change of blood and biochemiacl | within 1 month after operation | wbc/hgb/albumin/cea |
Countries
China
Outcome results
None listed