Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

Last updated: October 27, 2018
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Erectile Dysfunction

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT03706508
2016/0457
  • Ages 40-80
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • patients undergoing other treatments for adenocarcinoma of the prostate

  • conversion to open prostatectomy

  • loss of follow-up

Study Design

Total Participants: 120
Study Start date:
August 09, 2013
Estimated Completion Date:
November 30, 2018

Study 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.

Connect with a study center

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035 007
    Brazil

    Active - Recruiting

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