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Pentafecta Outcomes After Robot-assisted Laparoscopic Radical Prostatectomy

H

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Complication of Surgical Procedure
Erectile Dysfunction
Prostate Cancer
Urinary Incontinence

Treatments

Procedure: Robot-assisted laparoscopic radical prostatectomy

Study type

Observational

Funder types

Other

Identifiers

NCT03706508
2016/0457

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

Male

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Brasil S Neto, PhD; Eduardo T Cachoeira, MD

Data sourced from clinicaltrials.gov

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