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
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
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