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Trial record 3 of 5 for:    colon cancer | ( Map: Vietnam )

Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

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ClinicalTrials.gov Identifier: NCT03931980
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
NGUYEN PHUC MINH, Binh Dan Hospital

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

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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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 28, 2021

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931980


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

Locations
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Vietnam
Binh Dan hospital Recruiting
Ho Chi Minh City, Vietnam, 70000
Contact: Minh P Nguyen, MD         
Sponsors and Collaborators
Binh Dan Hospital
Investigators
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Study Director: Hung V Tran, PhD Binh Dan Hospital

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Responsible Party: NGUYEN PHUC MINH, Medical Doctor, 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: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NGUYEN PHUC MINH, Binh Dan Hospital:
rectal cancer
robotic surgery
laparoscopic surgery

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases