Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy

August 4, 2017 updated by: Jesus Muñoz-Rodriguez, Corporacion Parc Tauli

Valuation Of Vascular Changes And Their Impact On Erectile Function By Penile Doppler Ultrasound And Analysis Of The Quality Of Life Of Patients Undergoing Laparoscopic Radical Prostatectomy

A study designed to evaluate vascular changes after radical laparoscopic prostatectomy using Doppler ultrasound and the impact of such changes on erectile function and quality of life of patients. The baseline study will be compared with the study one year after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

Description

Inclusion Criteria:

  • Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

Exclusion Criteria:

  • Patients who were not interested in their sexual function and refused to perform this study
  • Patients who required adjuvant or salvage treatment for their prostate cancer (radiation therapy, chemotherapy or androgen deprivation therapy) during follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group #1
Patients with prostate cancer who will undergo radical prostatectomy
Diagnostic test: Doppler ultrasound
Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left and right Cavernous artery diameter
Time Frame: 1 year
mm
1 year
Left and right Systolic velocity cavernous artery
Time Frame: 1 year
cm/s
1 year
Left and right Diastolyc velocity cavernous artery
Time Frame: 1 year
cm/s
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Jesus Muñoz-Rodriguez, MD, Corporacio Sanitaria Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2011

Primary Completion (Actual)

August 2, 2017

Study Completion (Actual)

August 2, 2017

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RadicalDoppler

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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