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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

Clinicaltrials.gov identifier NCT03931980

Recruitment Status Recruiting

First Posted April 30, 2019

Last update posted July 14, 2020

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:Rectal Cancer
  • Intervention/Treatment: Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
  • Phase: N/A
Detailed Description

Rectal cancer is a common surgical disease

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: February 2021
Arms and interventions
Arm Intervention/treatment
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
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
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
  • 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
Contacts

Contact: Minh P Nguyen, MD 084 0918151851 bsphucminh@gmail.com

Locations

Vietnam
Binh Dan hospital
Ho Chi Minh City

Sponsors and Collaborators

Binh Dan Hospital

Investigators

Study Director: Hung V Tran, PhD Binh Dan Hospital

More Information
  • Responsible Party: Binh Dan Hospital
  • ClinicalTrials.gov Identifier: NCT03931980 History of Changes
  • Other Study ID Numbers: BD012019
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: July 14, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • 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 Binh Dan Hospital: rectal cancer
    robotic surgery
    laparoscopic surgery
  • Additional relevant MeSH terms: Rectal Neoplasms