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

Primary Purpose

Rectal Neoplasms, Sexual Dysfunction, Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Robotic
Laparoscopic
Sponsored by
Instituto Nacional de Cancer, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal neoplasms, sexual dysfunctions, Urinary incontinence, Quality of life, robotic surgical procedures, laparoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Instituto Nacional de Câncer- INCARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic

Laparoscopic

Arm Description

Robotic low anterior resection

Laparoscopic low anterior resection

Outcomes

Primary Outcome Measures

Urinary dysfunction
Urodynamic test

Secondary Outcome Measures

Sexual dysfunction
Quality of life questionnaire
Post operative outcomes
Post operative complications
Costs
Costs in Brazilian currency of each procedure

Full Information

First Posted
April 10, 2017
Last Updated
October 14, 2019
Sponsor
Instituto Nacional de Cancer, Brazil
Collaborators
Hospital de Câncer de Barretos, Hospital dos Servidores do Estado do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT03209076
Brief Title
Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer
Acronym
RAR
Official Title
Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer: A Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cancer, Brazil
Collaborators
Hospital de Câncer de Barretos, Hospital dos Servidores do Estado do Rio de Janeiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms, Sexual Dysfunction, Urinary Incontinence, Quality of Life
Keywords
rectal neoplasms, sexual dysfunctions, Urinary incontinence, Quality of life, robotic surgical procedures, laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robotic
Arm Type
Experimental
Arm Description
Robotic low anterior resection
Arm Title
Laparoscopic
Arm Type
Active Comparator
Arm Description
Laparoscopic low anterior resection
Intervention Type
Procedure
Intervention Name(s)
Robotic
Intervention Description
Robotic low anterior resection
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic
Intervention Description
Laparoscopic low anterior resection
Primary Outcome Measure Information:
Title
Urinary dysfunction
Description
Urodynamic test
Time Frame
Change from Before surgery to 3 months after surgery
Secondary Outcome Measure Information:
Title
Sexual dysfunction
Description
Quality of life questionnaire
Time Frame
Change from Before surgery to 3 months after surgery
Title
Post operative outcomes
Description
Post operative complications
Time Frame
Within the first 30 days after the surgical procedure
Title
Costs
Description
Costs in Brazilian currency of each procedure
Time Frame
From the surgical procedure until the last follow up, which will be 24 months or the day of death.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Valadão, Dr
Phone
55 21 32071161
Email
drmarcusvaladao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Valadão, Dr
Organizational Affiliation
Instituto Nacional de Câncer-INCA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Câncer- INCA
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20230-130
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Valadão, Dr
Phone
55 21 98103-9232
Email
drmarcusvaladao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27038996
Citation
de Jesus JP, Valadao 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.
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Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

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