Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer (RAR)

Instituto Nacional de Cancer, Brazil

Status: Unknown

Conditions: Quality of Life; Sexual Dysfunction; Rectal Neoplasms; Urinary Incontinence

Treatments: Procedure: Robotic; Procedure: Laparoscopic

Study type: Interventional

Funder types: Other

Identifiers

NCT03209076

RAR Trial

Details and patient eligibility

About

Prospective randomized trial comparing robotic versus laparoscopic Low anterior resection for rectal cancer.

Primary endpoint: Compare urinary dysfunction between robotic and laparoscopic approach.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

Robotic

Experimental group

Description:

Robotic low anterior resection

Treatment:

Procedure: Robotic

Laparoscopic

Active Comparator group

Description:

Laparoscopic low anterior resection

Treatment:

Procedure: Laparoscopic