Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study

Conditions
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Rectal Neoplasms, Sexual Dysfunction, Urinary Incontinence, Quality of Life

Intervention / Treatment
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* Procedure: Robotic
* Procedure: Laparoscopic


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic<br>Robotic low anterior resection | Procedure: Robotic<br>* Robotic low anterior resection<br>|
| Active Comparator: Laparoscopic<br>Laparoscopic low anterior resection | Procedure: Laparoscopic<br>* Laparoscopic low anterior resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary dysfunction | Urodynamic test | Change from Before surgery to 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual dysfunction | Quality of life questionnaire | Change from Before surgery to 3 months after surgery | 
| Post operative outcomes | Post operative complications | Within the first 30 days after the surgical procedure | 
| Costs | Costs in Brazilian currency of each procedure | From the surgical procedure until the last follow up, which will be 24 months or the day of death. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal neoplasms, sexual dysfunctions, Urinary incontinence, Quality of life, robotic surgical procedures, laparoscopy