Domestic Surgical Robot Clinical Study

Central South University

Status: Unknown

Conditions: Gastric Bypass; Appendicitis; Gastric Cancer; Cholecystolithiasis; Gastric Ulcer With Perforation But Without Obstruction; Colon Cancer; Sleeve Gastrectomy; Rectal Cancer

Treatments: Procedure: Micro Hand S robotic surgery; Procedure: laparoscopic surgery; Procedure: da Vinci robotic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02752698

XY3-DSRCS1507A01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Micro Hand S robotic group

Experimental group

Description:

Micro Hand S robotic surgery group

Treatment:

Procedure: Micro Hand S robotic surgery

laparoscopic surgery

Other group

Description:

laparoscopic surgery group

Treatment:

Procedure: laparoscopic surgery

da Vinci robotic group

Other group

Description:

da Vinci robotic robotic group

Treatment:

Procedure: da Vinci robotic surgery