Clinical trial NCT02752698: Domestic Surgical Robot Clinical Study
Official title: Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Ulcer With Perforation But Without Obstruction
Colon Cancer
Cholecystolithiasis
Appendicitis
Sleeve Gastrectomy
Gastric Bypass
Gastric Cancer
Rectal Cancer
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: intraoperative outcomes
timeFrame: up to 1 week after operation
measure: postoperative outcomes
timeFrame: up to 1 month after operation
measure: pathological outcomes
timeFrame: up to 1 month after operation
measure: complication
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: functional outcomes
timeFrame: at least12 months after operation
measure: recurrence
timeFrame: at least 12 months after operation
measure: survival
timeFrame: at least 12 months yesra after operation
measure: change of blood and biochemiacl
timeFrame: within 1 month after operation
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: shaihong zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lei Y, Jiang J, Zhu S, Yi B, Li J. Comparison of the short-term efficacy of two types of robotic total mesorectal excision for rectal cancer. Tech Coloproctol. 2022 Jan;26(1):19-28. doi: 10.1007/s10151-021-02546-0. Epub 2021 Nov 30.
citation: Zeng Y, Wang G, Li Z, Lin H, Zhu S, Yi B. The Micro Hand S vs. da Vinci Surgical Robot-Assisted Surgery on Total Mesorectal Excision: Short-Term Outcomes Using Propensity Score Matching Analysis. Front Surg. 2021 May 11;8:656270. doi: 10.3389/fsurg.2021.656270. eCollection 2021.