Robotic Versus Laparoscopic Low Anterior Resection for Rectal Cancer

NCT03209076 — Not applicable, Unknown, 120 participants, Instituto Nacional de Cancer, Brazil

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

Registry	NCT03209076, acronym RAR
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	120 (Estimated)
Sponsor	Instituto Nacional de Cancer, Brazil (Other gov); collaborators: Hospital de Câncer de Barretos, Hospital dos Servidores do Estado do Rio de Janeiro
Conditions	Rectal Neoplasms, Sexual Dysfunction, Urinary Incontinence, Quality of Life
Interventions	Robotic, Laparoscopic (Procedure)
Dates	start 2018-02-01, primary completion 2020-06-01 (estimated), completion 2020-12-01 (estimated), first posted 2017-07-06, last updated 2019-10-16
Locations	1 site in Brazil

-Summary

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

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Robotic	Experimental	Procedure: Robotic	Robotic low anterior resection
Laparoscopic	Active comparator	Procedure: Laparoscopic	Laparoscopic low anterior resection

Robotic (Procedure): Robotic low anterior resection
Laparoscopic (Procedure): Laparoscopic low anterior resection

+Outcome measures

Primary outcomes

Urinary dysfunction [Change from Before surgery to 3 months after surgery]: Urodynamic test

Secondary outcomes

Sexual dysfunction [Change from Before surgery to 3 months after surgery]: Quality of life questionnaire
Post operative outcomes [Within the first 30 days after the surgical procedure]: Post operative complications
Costs [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

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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)

+Locations (1)

Facility	City	Country	Status
Instituto Nacional de Câncer- INCA	Rio de Janeiro, Rio de Janeiro	Brazil	Recruiting

+Publications

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 27038996

+Investigators

Marcus Valadão, Dr, Principal investigator, Instituto Nacional de Câncer-INCA

My Notes

Public

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