NCT03931980

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2021

Completed
Last Updated

March 14, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

April 3, 2019

Last Update Submit

March 10, 2022

Conditions

Rectal Cancer

Keywords

rectal cancerrobotic surgerylaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Conversion to open surgery

    the rate of conversion to open surgery

    1 day

Secondary Outcomes (1)

  • Time of surgery

    1 day

Study Arms (2)

Robotic surgery

EXPERIMENTAL

Patients undergoing robotic surgery for removal of rectal cancer.

Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection

Laparoscopic surgery

EXPERIMENTAL

Patients undergoing laparoscopic for removal of rectal cancer

Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection

Interventions

Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resectionPROCEDURE

we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer

Also known as: Laparoscopic rectal cancer resection, Da Vinci robotic system, Rectal cancer surgery, Robotic rectal cancer surgery
Laparoscopic surgeryRobotic surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Advanced cancer not amenable to curative surgery
  • patient did not agree to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binh Dan hospital

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Hung V Tran, PhD

    Binh Dan Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 30, 2019

Study Start

January 1, 2019

Primary Completion

March 4, 2021

Study Completion

June 11, 2021

Last Updated

March 14, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)