Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer. Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Robotic low anterior resection
Laparoscopic low anterior resection
Instituto Nacional de Câncer- INCA
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGUrinary dysfunction
Urodynamic test
Time frame: Change from Before surgery to 3 months after surgery
Sexual dysfunction
Quality of life questionnaire
Time frame: Change from Before surgery to 3 months after surgery
Post operative outcomes
Post operative complications
Time frame: Within the first 30 days after the surgical procedure
Costs
Costs in Brazilian currency of each procedure
Time frame: From the surgical procedure until the last follow up, which will be 24 months or the day of death.
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