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Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT03706508
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Erectile Dysfunction Complication of Surgical Procedure Urinary Incontinence Procedure: Robot-assisted laparoscopic radical prostatectomy

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy: First 120 Cases in Brazilian University Hospital
Actual Study Start Date : August 9, 2013
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Robot-assisted laparoscopic radical prostatectomy
    Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy


Primary Outcome Measures :
  1. Erectile Dysfunction [ Time Frame: 6 months ]
    Sexual Health Inventory for Men (SHIM) score greater or equal to 21.


Secondary Outcome Measures :
  1. Urinary Continence [ Time Frame: 6 months ]
    Continence was defined as patients who remain dry and who do not require any kind of protection.Patients will be questioned in the postoperative consultations if there is a need to use some protection.

  2. Surgical Complication [ Time Frame: 30 days ]
    Complications were categorized according to the Clavien classification system.

  3. Biochemical Failure [ Time Frame: 6 month ]
    Biochemical failure was established by PSA level grater or equal to 0,2 ng/ml.

  4. Surgical Margin [ Time Frame: 15 days ]
    It is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between 40 and 75 diagnosed with localized prostate cancer submitted to robot-assisted laparoscopic radical prostatectomy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706508


Contacts
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Contact: Brasil S Neto, PhD +55 51 33598286 bneto@hcpa.edu.br
Contact: Eduardo T Cachoeira, MD +55 51 998123454 cachoeira.uro@gmail.com

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035 007
Contact: Brasil S Neto, PhD    +55 51 33598286    bneto@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Brasil S Neto, PhD Hospital de Clinicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03706508     History of Changes
Other Study ID Numbers: 2016/0457
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Robot-assisted prostatectomy
Pentafecta
Biochemical failure
Surgical margin

Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Erectile Dysfunction
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological