Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Neoplasms
- Sponsor
- Instituto Nacional de Cancer, Brazil
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Urinary dysfunction
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Marcus Valadão
Principal Investigator
Instituto Nacional de Cancer, Brazil
Eligibility Criteria
Inclusion Criteria
- •Mid or low Rectal Adenocarcinoma
- •Performance Status (ECOG) 0 - 2
Exclusion Criteria
- •Metastatic disease
- •Congestive heart failure
- •Renal failure
- •Pregnancy
- •Neurologic disorders
- •Alfa blockers user
- •Patients who are candidates to APR ( Abdomino-perineal resection)
Outcomes
Primary Outcomes
Urinary dysfunction
Time Frame: Change from Before surgery to 3 months after surgery
Urodynamic test
Secondary Outcomes
- Sexual dysfunction(Change from Before surgery to 3 months after surgery)
- Post operative outcomes(Within the first 30 days after the surgical procedure)
- Costs(From the surgical procedure until the last follow up, which will be 24 months or the day of death.)