Evaluation of the Satisfaction of the Patients Operated f... | NCT03474419

Studies
Evaluation of the Satisfaction of the Patients Operated for a Mild Hyperplasie of the Prostate by Laser in Ambulatory Surgery

NCT03474419

Sponsor

Fondation Hôpital Saint-Joseph

Status

Withdrawn

Last Update Posted

Feb 4, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prostatic Hyperplasia

Interventions

laser surgery

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 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The principal investigator decide to stop the sudy.

Expanded Access Info

Start Date

Nov 24, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Mar 16, 2018

First Submission Date that Met QC Criteria

Mar 16, 2018

First Posted Date

Mar 22, 2018Actual

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

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

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

Every year more than 70 000 interventions for prostatic adenoma are realized. Several type of surgery are realized going of the ambulatory to longer hospital lengths of stay. There are also several techniques.However it appears that ambulatory surgery is less costly. The arguments of surgeons are patients reluctance or the difficulty to manage in case of complication.

The aim of the study is to show that there is a good acceptance from patient with a good level of satisfaction at day 30.

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

0Actual

Name	Type	Description	Arm Group Labels	Other Names
laser surgery	Procedure	laser surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient satisfaction	analogic scale (0 to 10)	Day 30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age> 18
patient with benign prostatic hyperplasia
ambulatory eligibility

Exclusion Criteria:

recused for ambulatory surgery
Patients operated by surgeons not having ended their learning curve.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

only male

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

33 patients selected in the 6 center

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided