Impact of surgeon’s experience on operative outcomes of surgical prostate tissue removal.
| ISRCTN | ISRCTN29916004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29916004 |
| EudraCT/CTIS number | N/A |
| ClinicalTrials.gov number | N/A |
| Secondary identifying numbers | 2210559 |
- Submission date
- 16/12/2018
- Registration date
- 06/03/2019
- Last edited
- 20/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Department of Urology
Rennes
35000
France
 ORCID ID |
0000-0002-4124-789X |
|---|
Study information
| Study design | Retrospective, observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The surgical learning curve for green light endoscopic enucleation of the prostate: an international multicenter study |
| Study acronym | N/A |
| Study objectives | 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(s) | Approved 17/10/2018, CNIL, ref: 2210559. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2018 |
| Completion date | 15/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 900 |
| Total final enrolment | 922 |
| Key inclusion criteria | 1. Diagnosed with lower urinary tract symptoms due to benign prostatic obstruction (BPO) 2. Being treated with GreenLEP procedure |
| Key exclusion criteria | N/A |
| Date of first enrolment | 10/05/2018 |
| Date of final enrolment | 28/07/2018 |
Locations
Countries of recruitment
- France
- Italy
- Spain
Study participating centres
35000
France
31000
France
Barcelona
08000
Spain
Modena
41121
Italy
Madrid
28000
Spain
Sponsor information
Hospital/treatment centre
Rennes
Rennes
35000
France
"ROR" |
https://ror.org/015m7wh34 |
|---|
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Rennes 1
- Location
- France
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/09/2019 | 20/09/2021 | Yes | No |
Editorial Notes
20/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
08/03/2019: Internal review.
