Domestic Surgical Robot Clinical Study
Primary Purpose
Gastric Ulcer With Perforation But Without Obstruction, Colon Cancer, Cholecystolithiasis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Micro Hand S robotic surgery
laparoscopic surgery
da Vinci robotic surgery
Sponsored by
About this trial
This is an interventional other trial for Gastric Ulcer With Perforation But Without Obstruction
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
Sites / Locations
- The Third Xiangya Hospital of Central South University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
Micro Hand S robotic group
laparoscopic surgery
da Vinci robotic group
Arm Description
Micro Hand S robotic surgery group
laparoscopic surgery group
da Vinci robotic robotic group
Outcomes
Primary Outcome Measures
intraoperative outcomes
surgical procedure/operative time/console time/blood loss/conversion
postoperative outcomes
Time to first flatus/intake/hospital stay
pathological outcomes
resection margin/harvested lymph node/mesorectal grade
complication
type of complication/grade of complication
Secondary Outcome Measures
functional outcomes
wexner/ipss/iief score
recurrence
local recurrence and metastasis
survival
disease free survival/overall survival
change of blood and biochemiacl
wbc/hgb/albumin/cea
Full Information
NCT ID
NCT02752698
First Posted
June 15, 2015
Last Updated
March 29, 2021
Sponsor
The Third Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT02752698
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2015 (undefined)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Xiangya Hospital of Central South University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer With Perforation But Without Obstruction, Colon Cancer, Cholecystolithiasis, Appendicitis, Sleeve Gastrectomy, Gastric Bypass, Gastric Cancer, Rectal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Micro Hand S robotic group
Arm Type
Experimental
Arm Description
Micro Hand S robotic surgery group
Arm Title
laparoscopic surgery
Arm Type
Other
Arm Description
laparoscopic surgery group
Arm Title
da Vinci robotic group
Arm Type
Other
Arm Description
da Vinci robotic robotic group
Intervention Type
Procedure
Intervention Name(s)
Micro Hand S robotic surgery
Intervention Description
20-70 patients undergo Micro Hand S robotic surgeries
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Intervention Description
20-70 patients undergo laparoscopic surgeries
Intervention Type
Procedure
Intervention Name(s)
da Vinci robotic surgery
Intervention Description
20-70 patients undergo da Vinci robotic surgeries
Primary Outcome Measure Information:
Title
intraoperative outcomes
Description
surgical procedure/operative time/console time/blood loss/conversion
Time Frame
up to 1 week after operation
Title
postoperative outcomes
Description
Time to first flatus/intake/hospital stay
Time Frame
up to 1 month after operation
Title
pathological outcomes
Description
resection margin/harvested lymph node/mesorectal grade
Time Frame
up to 1 month after operation
Title
complication
Description
type of complication/grade of complication
Time Frame
within 30 days after surgery
Secondary Outcome Measure Information:
Title
functional outcomes
Description
wexner/ipss/iief score
Time Frame
at least12 months after operation
Title
recurrence
Description
local recurrence and metastasis
Time Frame
at least 12 months after operation
Title
survival
Description
disease free survival/overall survival
Time Frame
at least 12 months yesra after operation
Title
change of blood and biochemiacl
Description
wbc/hgb/albumin/cea
Time Frame
within 1 month after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shaihong zhu, MD
Organizational Affiliation
The Third Xiangya Hospital of Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34846614
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.
Results Reference
derived
PubMed Identifier
34046424
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.
Results Reference
derived
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Domestic Surgical Robot Clinical Study
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