Rectal Neoplasms, Sexual Dysfunction, Urinary Incontinence, Quality of Life
Conditions
Keywords
rectal neoplasms, sexual dysfunctions, Urinary incontinence, Quality of life, robotic surgical procedures, laparoscopy
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.
Interventions
PROCEDURERobotic
Robotic low anterior resection
PROCEDURELaparoscopic
Laparoscopic low anterior resection
Sponsors
Hospital de Câncer de Barretos
Hospital dos Servidores do Estado do Rio de Janeiro
Instituto Nacional de Cancer, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Mid or low Rectal Adenocarcinoma * Performance Status (ECOG) 0 - 2
Exclusion criteria
* Metastatic disease * Congestive heart failure * Renal failure * Diabetes * Pregnancy * Neurologic disorders * Alfa blockers user * Patients who are candidates to APR ( Abdomino-perineal resection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary dysfunction | Change from Before surgery to 3 months after surgery | Urodynamic test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual dysfunction | Change from Before surgery to 3 months after surgery | Quality of life questionnaire |
| Post operative outcomes | Within the first 30 days after the surgical procedure | Post operative complications |
| Costs | From the surgical procedure until the last follow up, which will be 24 months or the day of death. | Costs in Brazilian currency of each procedure |
Countries
Brazil
Contacts
Primary ContactMarcus Valadão, Dr
Outcome results
None listed