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出境医 / 临床实验 / Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

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".


Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection Not Applicable

Detailed Description:
Rectal cancer is a common surgical disease
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : March 4, 2021
Estimated Study Completion Date : April 28, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Robotic surgery
Patients undergoing robotic surgery for removal of rectal cancer.
 Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
Other Names:
  • Laparoscopic rectal cancer resection
  • Da Vinci robotic system
  • Rectal cancer surgery
  • Robotic rectal cancer surgery
Experimental: Laparoscopic surgery
Patients undergoing laparoscopic for removal of rectal cancer
 Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
Other Names:
  • Laparoscopic rectal cancer resection
  • Da Vinci robotic system
  • Rectal cancer surgery
  • Robotic rectal cancer surgery
Outcome Measures
Primary Outcome Measures :
  1. Conversion to open surgery [ Time Frame: 1 day ]
    the rate of conversion to open surgery


Secondary Outcome Measures :
  1. Time of surgery [ Time Frame: 1 day ]
    Time of surgery on the robot compare to laparoscopic surgery


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Vietnam
Binh Dan hospital
Ho Chi Minh City, Vietnam, 70000
Sponsors and Collaborators
Binh Dan Hospital
Investigators
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Study Director: Hung V Tran, PhD Binh Dan Hospital
Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date March 5, 2021
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date March 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		Conversion to open surgery [ Time Frame: 1 day ]
the rate of conversion to open surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		Time of surgery [ Time Frame: 1 day ]
Time of surgery on the robot compare to laparoscopic surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
Official Title  ICMJE Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
Other Names:
  • Laparoscopic rectal cancer resection
  • Da Vinci robotic system
  • Rectal cancer surgery
  • Robotic rectal cancer surgery
Study Arms  ICMJE
  • Experimental: Robotic surgery
    Patients undergoing robotic surgery for removal of rectal cancer.
    Intervention: Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
  • Experimental: Laparoscopic surgery
    Patients undergoing laparoscopic for removal of rectal cancer
    Intervention: Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2021
Actual Primary Completion Date March 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931980
Other Study ID Numbers  ICMJE BD012019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party NGUYEN PHUC MINH, Binh Dan Hospital
Study Sponsor  ICMJE Binh Dan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hung V Tran, PhD Binh Dan Hospital
PRS Account Binh Dan Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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