Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer
NCT ID: NCT03209076
Last Updated: 2019-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-02-01
2020-12-01
Brief Summary
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Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic
Robotic low anterior resection
Robotic
Robotic low anterior resection
Laparoscopic
Laparoscopic low anterior resection
Laparoscopic
Laparoscopic low anterior resection
Interventions
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Robotic
Robotic low anterior resection
Laparoscopic
Laparoscopic low anterior resection
Eligibility Criteria
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Inclusion Criteria
* Performance Status (ECOG) 0 - 2
Exclusion Criteria
* Congestive heart failure
* Renal failure
* Diabetes
* Pregnancy
* Neurologic disorders
* Alfa blockers user
* Patients who are candidates to APR ( Abdomino-perineal resection)
18 Years
70 Years
ALL
No
Sponsors
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Hospital de Câncer de Barretos
OTHER
Hospital dos Servidores do Estado do Rio de Janeiro
OTHER_GOV
Instituto Nacional de Cancer, Brazil
OTHER_GOV
Responsible Party
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Marcus Valadão
Principal Investigator
Principal Investigators
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Marcus Valadão, Dr
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Câncer-INCA
Locations
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Instituto Nacional de Câncer- INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RAR Trial
Identifier Type: -
Identifier Source: org_study_id
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