Robotic Versus Laparoscopic Low Anterior Resection for Re... | NCT03209076

Studies
Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

NCT03209076

Sponsor

Instituto Nacional de Cancer, Brazil

Status

Unknown status

Last Update Posted

Oct 16, 2019Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Rectal Neoplasms
Sexual Dysfunction
Urinary Incontinence
Quality of Life

Interventions

Robotic
Laparoscopic

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jun 1, 2020Estimated

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Jul 3, 2017

First Posted Date

Jul 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2019

Last Update Posted Date

Oct 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcus Valadão, Principal Investigator, Instituto Nacional de Cancer, BrazilPrincipal Investigator

Lead Sponsor

Instituto Nacional de Cancer, BrazilOTHER_GOV

Collaborators

Name	Class
Hospital de Câncer de Barretos	OTHER
Hospital dos Servidores do Estado do Rio de Janeiro	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Robotic	Experimental	Robotic low anterior resection	Procedure: Robotic
Laparoscopic	Active Comparator	Laparoscopic low anterior resection	Procedure: Laparoscopic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Robotic	Procedure	Robotic low anterior resection	Robotic
Laparoscopic

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Sexual dysfunction	Quality of life questionnaire	Change from Before surgery to 3 months after surgery
Post operative outcomes	Post operative complications

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcus Valadão, Dr	Contact	55 21 32071161		drmarcusvaladao@gmail.com

Overall Officials

Name	Affiliation	Role
Marcus Valadão, Dr	Instituto Nacional de Câncer-INCA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Nacional de Câncer- INCA	Recruiting	Rio de Janeiro	Rio de Janeiro	20230-130	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27038996	Background	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.

ID	Term
D012004	Rectal Neoplasms
D012735	Sexual Dysfunction, Physiological
D014549	Urinary Incontinence

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D012371	Robotics
D010535	Laparoscopy

ID	Term
D001331	Automation
D013672	Technology
D013676	Technology, Industry, and Agriculture
D004724	Endoscopy