Back to resultsRobotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, robotic surgery, laparoscopic surgery
Eligibility Criteria
Inclusion Criteria:
- able to provide written informed consent
- Diagnosis of rectal cancer amenable to curative surgery by anterior resection, low anterior resection, ultra-low anterior resection, abdominal perineal resection, staged T1-T4a, N0-2, M0
Exclusion Criteria:
- Advanced cancer not amenable to curative surgery
- patient did not agree to participate in research
Sites / Locations
- Binh Dan hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Robotic surgery
Laparoscopic surgery
Arm Description
Patients undergoing robotic surgery for removal of rectal cancer.
Patients undergoing laparoscopic for removal of rectal cancer
Outcomes
Primary Outcome Measures
Conversion to open surgery
the rate of conversion to open surgery
Secondary Outcome Measures
Time of surgery
Time of surgery on the robot compare to laparoscopic surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03931980
Brief Title
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Official Title
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 4, 2021 (Actual)
Study Completion Date
June 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Binh Dan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Colorectal cancer is a common malignancy in Viet Nam. Laparoscopic surgery becomes a standard treatment in many centers. Today, robotic surgery is a new option for treating colorectal cancer with some advantages such as magnified 3D view, precise movements.
Answer on safety and feasibility of robotic surgery for colorectal cancer are not available in Viet Nam. Therefore, the investigators conducted a study " Robotic versus Laparoscopic Approach for Rectal Cancer Surgery".
Detailed Description
Rectal cancer is a common surgical disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, robotic surgery, laparoscopic surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic surgery
Arm Type
Experimental
Arm Description
Patients undergoing robotic surgery for removal of rectal cancer.
Arm Title
Laparoscopic surgery
Arm Type
Experimental
Arm Description
Patients undergoing laparoscopic for removal of rectal cancer
Intervention Type
Procedure
Intervention Name(s)
Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
Other Intervention Name(s)
Laparoscopic rectal cancer resection, Da Vinci robotic system, Rectal cancer surgery, Robotic rectal cancer surgery
Intervention Description
we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
Primary Outcome Measure Information:
Title
Conversion to open surgery
Description
the rate of conversion to open surgery
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time of surgery
Description
Time of surgery on the robot compare to laparoscopic surgery
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
able to provide written informed consent
Diagnosis of rectal cancer amenable to curative surgery by anterior resection, low anterior resection, ultra-low anterior resection, abdominal perineal resection, staged T1-T4a, N0-2, M0
Exclusion Criteria:
Advanced cancer not amenable to curative surgery
patient did not agree to participate in research
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung V Tran, PhD
Organizational Affiliation
Binh Dan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Binh Dan hospital
City
Ho Chi Minh City
ZIP/Postal Code
70000
Country
Vietnam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
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