Rectal CancerNCT03931980
Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
A study testing Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection in people with Rectal Cancer, run by Binh Dan Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2019to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Advanced cancer not amenable to curative surgery
- patient did not agree to participate in research
Trial locations and contacts
1 site in 1 country.
About this study
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".
Read the detailed description
Rectal cancer is a common surgical disease
- Conditions
- Rectal Cancer
- Being tested
- Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection
- Keywords
- rectal cancer, robotic surgery, laparoscopic surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resectionProcedure or surgery
Also called Laparoscopic rectal cancer resection, Da Vinci robotic system, Rectal cancer surgery, Robotic rectal cancer surgery
we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery | Experimental | Patients undergoing robotic surgery for removal of rectal cancer. Receives: Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection |
| Laparoscopic surgery | Experimental | Patients undergoing laparoscopic for removal of rectal cancer Receives: Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to open surgery
the rate of conversion to open surgery
Measured: 1 day
Secondary outcomes (1)
Time of surgery
Time of surgery on the robot compare to laparoscopic surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Jan 2019
- Primary completion4 Mar 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binh Dan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NGUYEN PHUC MINH, Binh Dan Hospital
- Investigators
- Hung V Tran, PhD, Study director, Binh Dan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931980
- Sponsor's protocol ID
- BD012019
- Status last verified
- Mar 2022
- First submitted
- 3 Apr 2019
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Laparoscopic Approach for Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03931980
- Acronym / sponsor ID
- BD012019
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, robotic surgery, laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Binh Dan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Detailed description
Rectal cancer is a common surgical disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery | Experimental | Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resectionPatients undergoing robotic surgery for removal of rectal cancer. |
| Laparoscopic surgery | Experimental | Procedure: Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resectionPatients undergoing laparoscopic for removal of rectal cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Advanced cancer not amenable to curative surgery
- patient did not agree to participate in research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resectionAlso: Laparoscopic rectal cancer resection, Da Vinci robotic system, Rectal cancer surgery, Robotic rectal cancer surgerywe perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer | Procedure or surgery | Laparoscopic surgery, Robotic surgery |
Primary outcome
Conversion to open surgery
Time frame: 1 day
the rate of conversion to open surgery
1 secondary outcome
Time of surgery
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung V Tran, PhD study director
Binh Dan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection in people with Rectal Cancer, run by Binh Dan Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion to open surgery (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.