Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209076
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : October 16, 2019
Sponsor:
Collaborators:
Hospital de Câncer de Barretos
Hospital dos Servidores do Estado do Rio de Janeiro
Information provided by (Responsible Party):
Marcus Valadão, 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.


Condition or disease Intervention/treatment Phase
Rectal Neoplasms Sexual Dysfunction Urinary Incontinence Quality of Life Procedure: Robotic Procedure: Laparoscopic Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Robotic
Robotic low anterior resection
Procedure: Robotic
Robotic low anterior resection

Active Comparator: Laparoscopic
Laparoscopic low anterior resection
Procedure: Laparoscopic
Laparoscopic low anterior resection




Primary Outcome Measures :
  1. Urinary dysfunction [ Time Frame: Change from Before surgery to 3 months after surgery ]
    Urodynamic test


Secondary Outcome Measures :
  1. Sexual dysfunction [ Time Frame: Change from Before surgery to 3 months after surgery ]
    Quality of life questionnaire

  2. Post operative outcomes [ Time Frame: Within the first 30 days after the surgical procedure ]
    Post operative complications

  3. Costs [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209076


Contacts
Layout table for location contacts
Contact: Marcus Valadão, Dr 55 21 32071161 drmarcusvaladao@gmail.com

Locations
Layout table for location information
Brazil
Instituto Nacional de Câncer- INCA Recruiting
Rio de Janeiro, RJ, Brazil, 20230-130
Contact: Marcus Valadão, Dr    55 21 98103-9232    drmarcusvaladao@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
Hospital de Câncer de Barretos
Hospital dos Servidores do Estado do Rio de Janeiro
Investigators
Layout table for investigator information
Principal Investigator: Marcus Valadão, Dr Instituto Nacional de Câncer-INCA
Publications:
Layout table for additonal information
Responsible Party: Marcus Valadão, Principal Investigator, Instituto Nacional de Cancer, Brazil
ClinicalTrials.gov Identifier: NCT03209076    
Other Study ID Numbers: RAR Trial
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcus Valadão, Instituto Nacional de Cancer, Brazil:
rectal neoplasms
sexual dysfunctions
Urinary incontinence
Quality of life
robotic surgical procedures
laparoscopy
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Urinary Incontinence
Enuresis
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders