Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

Quality of Life Clinical Trial

— RAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209076
• Other study ID #: RAR Trial
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2019
• Source: Instituto Nacional de Cancer, Brazil
• Contact: Marcus Valadão, Dr
• Phone: 55 21 32071161
• Email: drmarcusvaladao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Enuresis
• Quality of Life
• Rectal Neoplasms
• Sexual Dysfunction
• Urinary Incontinence

Intervention

Procedure:
• Robotic
Robotic low anterior resection
• Laparoscopic
Laparoscopic low anterior resection

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Câncer- INCA	Rio de Janeiro	RJ

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Cancer, Brazil	Hospital de Câncer de Barretos, Hospital dos Servidores do Estado do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

de Jesus JP, Valadão M, de Castro Araujo RO, Cesar D, Linhares E, Iglesias AC. The circumferential resection margins status: A comparison of robotic, laparoscopic and open total mesorectal excision for mid and low rectal cancer. Eur J Surg Oncol. 2016 Jun;42(6):808-12. doi: 10.1016/j.ejso.2016.03.002. Epub 2016 Mar 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary dysfunction	Urodynamic test	Change from Before surgery to 3 months after surgery
Secondary	Sexual dysfunction	Quality of life questionnaire	Change from Before surgery to 3 months after surgery
Secondary	Post operative outcomes	Post operative complications	Within the first 30 days after the surgical procedure
Secondary	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.