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

October 14, 2019 updated by: Marcus Valadão, Instituto Nacional de Cancer, Brazil

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

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Recruiting
        • Instituto Nacional de Câncer- INCA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Collaborators

Hospital de Câncer de Barretos
Hospital dos Servidores do Estado do Rio de Janeiro

Investigators

  • Principal Investigator: Marcus Valadão, Dr, Instituto Nacional de Cancer-INCA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 14, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAR Trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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