- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02752698
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
-
-
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
|
20-70 patients undergo Micro Hand S robotic surgeries
|
Other: laparoscopic surgery
laparoscopic surgery group
|
20-70 patients undergo laparoscopic surgeries
|
Other: da Vinci robotic group
da Vinci robotic robotic group
|
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.
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
- 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.
- 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.
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
- Digestive System Diseases
- Infections
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Peptic Ulcer
- Duodenal Diseases
- Gallbladder Diseases
- Biliary Tract Diseases
- Cecal Diseases
- Intraabdominal Infections
- Calculi
- Appendicitis
- Stomach Ulcer
- Gallstones
- Cholelithiasis
- Cholecystolithiasis
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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