Domestic Surgical Robot Clinical Study

C

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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