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

February 1, 2019 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

33 patients selected in the 6 center

Description

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.

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

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 24, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSTATAMBU

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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