Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery

March 10, 2022 updated by: NGUYEN PHUC MINH, Binh Dan Hospital

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rectal cancer is a common surgical disease

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Binh Dan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion to open surgery
Time Frame: 1 day
the rate of conversion to open surgery
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of surgery
Time Frame: 1 day
Time of surgery on the robot compare to laparoscopic surgery
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Binh Dan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

March 4, 2021

Study Completion (ACTUAL)

June 11, 2021

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (ACTUAL)

April 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 14, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD012019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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