NCT03474419

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 4, 2019

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

March 16, 2018

Last Update Submit

February 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    analogic scale (0 to 10)

    Day 30

Interventions

laser surgeryPROCEDURE

laser surgery

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsonly male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

33 patients selected in the 6 center

You may qualify if:

  • Age\> 18
  • patient with benign prostatic hyperplasia
  • ambulatory eligibility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 22, 2018

Study Start

November 24, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 4, 2019

Record last verified: 2018-08