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Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Sponsor
Binh Dan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03931980
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
29.3
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

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
  • Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
 N/A

Detailed Description

Rectal cancer is a common surgical disease

Study Design

Study Type:
Interventional
Actual 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 :
Jan 1, 2019
Actual Primary Completion Date :
Mar 4, 2021
Actual Study Completion Date :
Jun 11, 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 [1 day]

      the rate of conversion to open surgery

    Secondary Outcome Measures

    1. Time of surgery [1 day]

      Time of surgery on the robot compare to laparoscopic surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Binh Dan hospital Ho Chi Minh City Vietnam 70000

    Sponsors and Collaborators

    • Binh Dan Hospital

    Investigators

    • Study Director: Hung V Tran, PhD, Binh Dan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NGUYEN PHUC MINH, Medical Doctor, Binh Dan Hospital
    ClinicalTrials.gov Identifier:
    NCT03931980
    Other Study ID Numbers:
    • BD012019
    First Posted:
    Apr 30, 2019
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NGUYEN PHUC MINH, Medical Doctor, Binh Dan Hospital
    rectal cancer
    robotic surgery
    laparoscopic surgery
    Additional relevant MeSH terms:
    Rectal Neoplasms

    Study Results

    No Results Posted as of Mar 14, 2022