Domestic Surgical Robot Clinical Study

March 29, 2021 updated by: The Third Xiangya Hospital of Central South University

Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Micro Hand S robotic group
Micro Hand S robotic surgery group
Procedure: Micro Hand S robotic surgery
20-70 patients undergo Micro Hand S robotic surgeries
Other: laparoscopic surgery
laparoscopic surgery group
Procedure: laparoscopic surgery
20-70 patients undergo laparoscopic surgeries
Other: da Vinci robotic group
da Vinci robotic robotic group
Procedure: da Vinci robotic surgery
20-70 patients undergo da Vinci robotic surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative outcomes
Time Frame: up to 1 week after operation
surgical procedure/operative time/console time/blood loss/conversion
up to 1 week after operation
postoperative outcomes
Time Frame: up to 1 month after operation
Time to first flatus/intake/hospital stay
up to 1 month after operation
pathological outcomes
Time Frame: up to 1 month after operation
resection margin/harvested lymph node/mesorectal grade
up to 1 month after operation
complication
Time Frame: within 30 days after surgery
type of complication/grade of complication
within 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional outcomes
Time Frame: at least12 months after operation
wexner/ipss/iief score
at least12 months after operation
recurrence
Time Frame: at least 12 months after operation
local recurrence and metastasis
at least 12 months after operation
survival
Time Frame: at least 12 months yesra after operation
disease free survival/overall survival
at least 12 months yesra after operation
change of blood and biochemiacl
Time Frame: within 1 month after operation
wbc/hgb/albumin/cea
within 1 month after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: shaihong zhu, MD, The Third Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XY3-DSRCS1507A01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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