NCT03209076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

2.3 years

First QC Date

April 10, 2017

Last Update Submit

October 14, 2019

Conditions

Rectal NeoplasmsSexual DysfunctionUrinary IncontinenceQuality of Life

Keywords

rectal neoplasmssexual dysfunctionsUrinary incontinenceQuality of liferobotic surgical procedureslaparoscopy

Outcome Measures

Primary Outcomes (1)

  • Urinary dysfunction

    Urodynamic test

    Change from Before surgery to 3 months after surgery

Secondary Outcomes (3)

  • Sexual dysfunction

    Change from Before surgery to 3 months after surgery

  • Post operative outcomes

    Within the first 30 days after the surgical procedure

  • Costs

    From the surgical procedure until the last follow up, which will be 24 months or the day of death.

Study Arms (2)

Robotic

EXPERIMENTAL

Robotic low anterior resection

Procedure: Robotic

Laparoscopic

ACTIVE COMPARATOR

Laparoscopic low anterior resection

Procedure: Laparoscopic

Interventions

RoboticPROCEDURE

Robotic low anterior resection

Robotic
LaparoscopicPROCEDURE

Laparoscopic low anterior resection

Laparoscopic

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mid or low Rectal Adenocarcinoma
  • Performance Status (ECOG) 0 - 2

You may not qualify if:

  • Metastatic disease
  • Congestive heart failure
  • Renal failure
  • Diabetes
  • Pregnancy
  • Neurologic disorders
  • Alfa blockers user
  • Patients who are candidates to APR ( Abdomino-perineal resection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Câncer- INCA

Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27038996BACKGROUND

MeSH Terms

Conditions

Rectal NeoplasmsSexual Dysfunction, PhysiologicalUrinary Incontinence

Interventions

RoboticsLaparoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesGenital DiseasesUrogenital DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AutomationTechnologyTechnology, Industry, and AgricultureEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marcus Valadão, Dr

    Instituto Nacional de Câncer-INCA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Valadão, Dr

CONTACT

55 21 32071161drmarcusvaladao@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2017

First Posted

July 6, 2017

Study Start

February 1, 2018

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

October 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)