Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

Not Applicable

• Conditions: Sexual Dysfunction; Rectal Neoplasms; Quality of Life; Urinary Incontinence
• Interventions: Procedure: Robotic; Procedure: Laparoscopic

• Registration Number: NCT03209076
• Lead Sponsor: Instituto Nacional de Cancer, Brazil

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.

Study Timeline

• Study First Submitted: 2017-04-10
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2018-02-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-16
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic	Robotic	Robotic low anterior resection
Laparoscopic	Laparoscopic	Laparoscopic low anterior resection

Primary Outcome Measures

Name	Time	Method
Urinary dysfunction	Change from Before surgery to 3 months after surgery	Urodynamic test

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Nacional de Câncer- INCA; 🇧🇷 Rio de Janeiro, RJ, Brazil