Vascular Changes Of Patients Undergoing Laparoscopic Radi... | NCT03241758

Studies
Vascular Changes Of Patients Undergoing Laparoscopic Radical Prostatectomy

NCT03241758

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

Aug 7, 2017Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Prostatic Neoplasms
Erectile Dysfunction Following Radical Prostatectomy

Interventions

Doppler ultrasound

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2011Actual

Primary Completion Date

Aug 2, 2017Actual

Completion Date

Aug 2, 2017Actual

First Submitted Date

Aug 3, 2017

First Submission Date that Met QC Criteria

Aug 4, 2017

First Posted Date

Aug 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2017

Last Update Posted Date

Aug 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group #1		Patients with prostate cancer who will undergo radical prostatectomy	Diagnostic Test: Doppler ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler ultrasound	Diagnostic Test	Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy	Group #1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Male patients with prostate cancer who underwent laparoscopic radical prostatectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jesus Muñoz-Rodriguez, MD	Corporació Sanitaria Parc Tauli	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018608	Ultrasonography, Doppler

Ancestor Terms

ID	Term
D014463	Ultrasonography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided