Rectal NeoplasmsRARNCT03209076
Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer
A study testing Robotic and Laparoscopic in people with Rectal Neoplasms and Sexual Dysfunction, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
Trial summary
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer. Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Neoplasms, Sexual Dysfunction, Urinary Incontinence
- What is being tested?
- Robotic and Laparoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 1 Dec 2020
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mid or low Rectal Adenocarcinoma
- Performance Status (ECOG) 0 - 2
Who cannot join
- Metastatic disease
- Congestive heart failure
- Renal failure
- Diabetes
- Pregnancy
- Neurologic disorders
- Alfa blockers user
- Patients who are candidates to APR ( Abdomino-perineal resection)
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Nacional de Câncer- INCA
Rio de Janeiro, Rio de Janeiro, 20230-130
Marcus Valadão, Dr, 55 21 98103-9232, drmarcusvaladao@gmail.com
About this study
Official title: Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.
Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.
Read the detailed description
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.
The Aim of the study is to compare two surgical approaches (robotic versus laparoscopic) for rectal cancer treatment regarding functional outcomes (sexual and urinary dysfunctions), quality of life, post operative outcomes and oncologic outcomes.
Patients with the diagnosis of T3 mid and low rectal cancer will be randomized to robotic or laparoscopic procedure after neoadjuvant chemoradiation. Quality of life questionnaires and Urodynamic test will be applied before and after the surgical procedures.
- Being tested
- Robotic, Laparoscopic
- Keywords
- rectal neoplasms, sexual dysfunctions, Urinary incontinence, Quality of life, robotic surgical procedures, laparoscopy
- Medical subject headings
- Rectal Neoplasms, Sexual Dysfunction, Physiological, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoboticProcedure or surgery
Robotic low anterior resection
LaparoscopicProcedure or surgery
Laparoscopic low anterior resection
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Experimental | Robotic low anterior resection Receives: Procedure: Robotic |
| Laparoscopic | Active comparator | Laparoscopic low anterior resection Receives: Procedure: Laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary dysfunction
Urodynamic test
Measured: Change from Before surgery to 3 months after surgery
Secondary outcomes (3)
Sexual dysfunction
Quality of life questionnaire
Measured: Change from Before surgery to 3 months after surgery
Post operative outcomes
Post operative complications
Measured: Within the first 30 days after the surgical procedure
Costs
Costs in Brazilian currency of each procedure
Measured: From the surgical procedure until the last follow up, which will be 24 months or the day of death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Feb 2018
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancer, Brazil
- Sponsor type
- Other government
- Collaborators
- Hospital de Câncer de Barretos, Hospital dos Servidores do Estado do Rio de Janeiro
- Responsible party
- Principal investigator, Marcus Valadão, Instituto Nacional de Cancer, Brazil
- Investigators
- Marcus Valadão, Dr, Principal investigator, Instituto Nacional de Câncer-INCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209076
- Sponsor's protocol ID
- RAR Trial
- Acronym
- RAR
- Status last verified
- Oct 2019
- First submitted
- 10 Apr 2017
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Jesus JP, Valadao M, de Castro Araujo RO, Cesar D, Linhares E, Iglesias AC. The circumferential resection margins status: A comparison of robotic, laparoscopic and open total mesorectal excision for mid and low rectal cancer. Eur J Surg Oncol. 2016 Jun;42(6):808-12. doi: 10.1016/j.ejso.2016.03.002. Epub 2016 Mar 23.
PubMed 27038996
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
- ClinicalTrials.gov ID
- NCT03209076
- Acronym / sponsor ID
- RAR / RAR Trial
- Keywords
- rectal neoplasms, sexual dysfunctions, Urinary incontinence, Quality of life, robotic surgical procedures, laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancer, BrazilOther government
- Collaborators
- Hospital de Câncer de Barretos, Hospital dos Servidores do Estado do Rio de Janeiro
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 6 Jul 2017 (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.
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.
Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.
Detailed description
Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.
The Aim of the study is to compare two surgical approaches (robotic versus laparoscopic) for rectal cancer treatment regarding functional outcomes (sexual and urinary dysfunctions), quality of life, post operative outcomes and oncologic outcomes.
Patients with the diagnosis of T3 mid and low rectal cancer will be randomized to robotic or laparoscopic procedure after neoadjuvant chemoradiation. Quality of life questionnaires and Urodynamic test will be applied before and after the surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Robotic | Experimental | Procedure: RoboticRobotic low anterior resection |
| Laparoscopic | Active comparator | Procedure: LaparoscopicLaparoscopic low anterior resection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mid or low Rectal Adenocarcinoma
- Performance Status (ECOG) 0 - 2
Key exclusion criteria (8 listed)
- Metastatic disease
- Congestive heart failure
- Renal failure
- Diabetes
- Pregnancy
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 |
|---|---|---|
| RoboticRobotic low anterior resection | Procedure or surgery | Robotic |
| LaparoscopicLaparoscopic low anterior resection | Procedure or surgery | Laparoscopic |
Primary outcome
Urinary dysfunction
Time frame: Change from Before surgery to 3 months after surgery
Urodynamic test
3 secondary outcomes
Sexual dysfunction
Time frame: Change from Before surgery to 3 months after surgery
Post operative outcomes
Time frame: Within the first 30 days after the surgical procedure
Costs
Time frame: From the surgical procedure until the last follow up, which will be 24 months or the day of death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Background: PubMed 27038996de Jesus JP, Valadao M, de Castro Araujo RO, Cesar D, Linhares E, Iglesias AC. The circumferential resection margins status: A comparison of robotic, laparoscopic and open total mesorectal excision for mid and low rectal cancer. Eur J Surg Oncol. 2016 Jun;42(6):808-12. doi: 10.1016/j.ejso.2016.03.002. Epub 2016 Mar 23.
- 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.
Marcus Valadão, Dr principal investigator
Instituto Nacional de Câncer-INCA
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 and Laparoscopic in people with Rectal Neoplasms and Sexual Dysfunction, run by Instituto Nacional de Cancer, Brazil at 1 site in Brazil.
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 8 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: status not confirmed, as of the sponsor's last update on 16 Oct 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Valadão, Dr (55 21 32071161, drmarcusvaladao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary dysfunction (time frame: Change from Before surgery to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209076, which also lists 1 linked publication.
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 16 Oct 2019.