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Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

NCT ID: NCT03706508

Last Updated: 2018-10-30

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

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-09

Study Completion Date

2018-11-30

Brief Summary

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Robot-assisted laparoscopic radical prostatectomy (RALRP) is a surgical technique for the treatment of prostate cancer. The aim of this study was to report our initial experience with RALRP, by applying the concept of pentafecta. Pentafecta consists of the five main outcomes in the postoperative period of RALRP: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.

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Detailed Description

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This study will describe a initial experience in RALRP in Brazilian University Hospital. The follow-up of patients was performed as an examination at the medical consultation every three months. Complications were categorized according to the Clavien classification system. Biochemical failure was established by PSA level. Continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. Sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (PDE-5) and a Sexual Health Inventory for Men (SHIM) score greater or equal to 21. Positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.

Conditions

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Prostate Cancer Erectile Dysfunction Complication of Surgical Procedure Urinary Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Robot-assisted laparoscopic radical prostatectomy

Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

• patients diagnosed with localized Prostate Adenocarcinoma submitted to surgical treatment with Robot-assisted laparoscopic radical prostatectomy

Exclusion Criteria

* patients undergoing other treatments for adenocarcinoma of the prostate
* conversion to open prostatectomy
* loss of follow-up
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brasil S Neto, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Brasil S Neto, PhD

Role: CONTACT

[email protected]
+55 51 33598286

Eduardo T Cachoeira, MD

Role: CONTACT

[email protected]
+55 51 998123454

Facility Contacts

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Brasil S Neto, PhD

Role: primary

[email protected]
+55 51 33598286

Other Identifiers

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2016/0457

Identifier Type: -

Identifier Source: org_study_id

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