Condition category
Urological and Genital Diseases
Date applied
16/12/2018
Date assigned
06/03/2019
Last edited
08/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The number of cases needed to become proficient in Green Light endoscopic enucleation of the prostate (GreenLEP) is the subject of continuous debate. The aim of this study is to investigate the effect of surgical experience (EXP) on perioperative outcomes of GreenLEP.

Who can participate?
Men aged over 18 years who have lower urinary tract symptoms due to Benign prostatic obstruction.

What does the study involve?
This is a retrospective review of patients diagnosed with lower urinary tract symptoms due to Benign prostatic obstruction and management with Green Light endoscopic enucleation between 2013 and 2018. The researchers gathered data about the surgery, the demographic characteristic of patients and their follow up. This is done to assess the surgical outcomes to this procedure.

What are the possible benefits and risks of participating?
There are no benefits or risks with participating.

Where is the study run from?
Rennes University Hospital.

When is the study starting and how long is it expected to run for?
January 2013 to July 2018.

Who is funding the study?
The University of Rennes.

Who is the main contact?
Dr Zine-Eddine Khene
Zineddine.khene@gmail.com

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Zine-Eddine Khene

ORCID ID

http://orcid.org/0000-0002-4124-789X

Contact details

Department of Urology
Rennes
35000
France

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

2210559

Study information

Scientific title

The surgical learning curve for green light endoscopic enucleation of the prostate:
an international multicenter study

Acronym

N/A

Study hypothesis

The aim of this study was to define the surgical learning curve for GreenLEP using a large, multi-institutional dataset of patients treated by surgeons with extensive experience in transurethral resection of the prostate and open simple prostatectomy but none of them had any previous experience with the enucleation procedure. Our hypothesis proposed an initial learning phase, where clinical outcomes are heavily affected by surgical experience followed by a later plateau phase, where the impact of experience is negligible.

Ethics approval

Approved 17/10/2018, CNIL, ref: 2210559.

Study design

Retrospective, observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Benign prostatic obstruction

Intervention

Medical records of patients diagnosed with lower urinary tract symptoms due to Benign prostatic obstruction and management with GreenLEP procedure (technical surgery of BPO) with a standardized technique between 2013 and 2018 was assessed. The perioperative results of Surgeons were evaluated and modelling to assess their learning curve.

A prospectively maintained database of patients diagnosed with lower urinary tract symptoms due to BPO and management with GreenLEP procedure with a standardized technique between 2013 and 2018 at five tertiary care referral European Centres was assessed. Multivariable linear and logistic regression models were fitted to evaluate the effect of EXP on total operative time (OT), the probability of at least one intraoperative complication (IOC) , and the probability of Pentafecta achievement.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

To be taken from the surgical reports:
1. The total operative time is measured using the data from the cases.
2. The probability of at least one complication during the surgery. Complications include:
1.1. Capsule perforation.
1.2. Bladder wall injury.
1.3. Intraoperative bleeding requiring conversion to TURP or open simple prostatectomy or leading to a failed morcellation.

Secondary outcome measures

1. Achievement of optimum outcomes in prostate enucleation will be measured using Pentafecta achievement (defined as a combination of complete enucleation and morcellation within <90 min without any conversion to standard TURP, no postoperative complications and no stress urinary incontinence) at 3 months
2. Three-month postoperative symptom score reduction will be measured using the IPSS questionnaire.

Overall trial start date

01/05/2018

Overall trial end date

15/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with lower urinary tract symptoms due to benign prostatic
obstruction (BPO)
2. Being treated with GreenLEP procedure

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

900

Participant exclusion criteria

N/A

Recruitment start date

10/05/2018

Recruitment end date

28/07/2018

Locations

Countries of recruitment

France, Italy, Spain

Trial participating centre

Department of Urology
Rennes
35000
France

Trial participating centre

Department of Urology- Clinique Pasteur
Toulouse
31000
France

Trial participating centre

Department of Urology,
Hospital Quiron Barcelona
Barcelona
08000
Spain

Trial participating centre

Department of Urology,
Hesperia Hospital
Modena
41121
Italy

Trial participating centre

Department of Urology,
ICUA-Clinica CEMTRO
Madrid
28000
Spain

Sponsor information

Organisation

Rennes University Hospital, department of Urologie

Sponsor details

Rennes
Rennes
35000
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Université de Rennes 1

Alternative name(s)

University of Rennes 1

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

France

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/03/2019: Internal review.