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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
200
20-70 patients undergo Micro Hand S robotic surgeries
20-70 patients undergo laparoscopic surgeries
20-70 patients undergo da Vinci robotic surgeries
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
intraoperative outcomes
surgical procedure/operative time/console time/blood loss/conversion
Time frame: up to 1 week after operation
postoperative outcomes
Time to first flatus/intake/hospital stay
Time frame: up to 1 month after operation
pathological outcomes
resection margin/harvested lymph node/mesorectal grade
Time frame: up to 1 month after operation
complication
type of complication/grade of complication
Time frame: within 30 days after surgery
functional outcomes
wexner/ipss/iief score
Time frame: at least12 months after operation
recurrence
local recurrence and metastasis
Time frame: at least 12 months after operation
survival
disease free survival/overall survival
Time frame: at least 12 months yesra after operation
change of blood and biochemiacl
wbc/hgb/albumin/cea
Time frame: within 1 month after operation
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