Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

NCT ID: NCT03209076

Last Updated: 2019-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Rectal Neoplasms Sexual Dysfunction Urinary Incontinence Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic

Robotic low anterior resection

Group Type EXPERIMENTAL

Robotic

Intervention Type PROCEDURE

Robotic low anterior resection

Laparoscopic

Laparoscopic low anterior resection

Group Type ACTIVE_COMPARATOR

Laparoscopic

Intervention Type PROCEDURE

Laparoscopic low anterior resection

Interventions

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Robotic

Robotic low anterior resection

Intervention Type PROCEDURE

Laparoscopic

Laparoscopic low anterior resection

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Câncer de Barretos

OTHER

Sponsor Role collaborator

Hospital dos Servidores do Estado do Rio de Janeiro

OTHER_GOV

Sponsor Role collaborator

Instituto Nacional de Cancer, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Marcus Valadão

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcus Valadão, Dr

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Câncer-INCA

Locations

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Instituto Nacional de Câncer- INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marcus Valadão, Dr

Role: CONTACT

55 21 32071161

Facility Contacts

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Marcus Valadão, Dr

Role: primary

55 21 98103-9232

References

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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.

Reference Type BACKGROUND
PMID: 27038996 (View on PubMed)

Other Identifiers

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RAR Trial

Identifier Type: -

Identifier Source: org_study_id

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