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Trial registered on ANZCTR
Registration number
ACTRN12618000575235
Ethics application status
Approved
Date submitted
19/11/2017
Date registered
16/04/2018
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results information initially provided
11/02/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Assessment of surgeon's experience and stress in combination with peri-operative outcomes during the initial learning curve of Holmium Laser Enucleation of Prostate.
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Scientific title
Determining surgeon's stress levels during the initial learning curve of Holmium Laser Enucleation of Prostate and assessing the perioperative efficacy of the treatment.
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Secondary ID [1]
293397
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia
305542
0
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Condition category
Condition code
Renal and Urogenital
304774
304774
0
0
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Other renal and urogenital disorders
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Surgery
306512
306512
0
0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Holmium Laser Enucleation of Prostate (HoLEP).
This operation involves a transurethral enucleation of the prostatic adenoma, with the use of Holmium Laser. This is the first part of the procedure, when the tissue is enucleated and then during the second part, the enucleated tissue with the use of a morcellator is removed.
The length of operation (HOLEP) depends on surgical experience and prostate size ranging from 30min to 180 min.
TURP (transurethral resection of the prostate) is the classic method for the management of benign prostatic enlargement. During the initial learning curve of HoLEP, if a surgeon finds very difficult to complete the enucleation due to different reasons, eg lack o view, inability to find and maintain the plane between adenoma and prostatic capsule, he can converts to TURP in order to avoid significant complications.. In TURP, with the respectoscope, chips of prostate are removed to create a good cavity in prostatic urethra and treat the bladder outflow obstruction.
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Intervention code [1]
299643
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Treatment: Surgery
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
303996
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Enucleation efficiency
(weight of enucleated tissue divided by lasing time). Lasing time will be extracted automatically by laser device.
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Assessment method [1]
303996
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Timepoint [1]
303996
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Immediate following surgery
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Primary outcome [2]
303997
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Surgeon’s stress levels. Stress during HoLEP will be assessed by measuring heart rate of the surgeon with an armband heart rate monitor and by the surgeon himself, using a self-evaluation questionnaire immediately after the procedure, the state-trait anxiety inventory for adults (STAI Form Y-1). Scores <40 will be considered as acceptable stress, 40-60 moderate stress and >60 as significant stress. This will be done in each case and comparisons will be made in groups of 10 patients.
This is a composite primary outcome with the STAI Form Y-I referring to the stress levels during the operation.
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Assessment method [2]
303997
0
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Timepoint [2]
303997
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Maximum heart rate during the operation and completion of STAI Form Y-1 at completion of operation.
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Primary outcome [3]
304759
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Laser to prostate ratio (L/P ratio; amount of consumed laser energy divided by retrieved prostate tissue weight). Laser energy will be extracted automatically by laser device and measured in Kj.
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Assessment method [3]
304759
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Timepoint [3]
304759
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Immediate following surgery
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Secondary outcome [1]
340677
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Conversion to TURP. Number of cases and percent that will need conversion to classic Transurethral Resection of Prostate (TURP) due to difficulty - inability of surgeon under the learning curve to complete the HolEP. This will be determined by surgeon's records in patient's operation notes.
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Assessment method [1]
340677
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Timepoint [1]
340677
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Immediate following surgery
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Secondary outcome [2]
340678
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Percent reduction of PSA (Prostatic Specific Antigen) post HoLEP. The PSA will be measured with Beckmann serum assay.
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Assessment method [2]
340678
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Timepoint [2]
340678
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PSA will be measured before operation and 3 months after the procedure. Percent of PSA reduction will be used as a surrogate marker of postoperative reduction in prostate volume.
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Secondary outcome [3]
340679
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Complication rates according to Clavien Dindo modified classification.
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Assessment method [3]
340679
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Timepoint [3]
340679
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Complications of each procedure, including intra-operative and post-operative will be assessed during hospital stay, 1 month and 3 months post-operatively.
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Secondary outcome [4]
340680
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Morcellation efficiency
(Weight of enucleated tissue divided by time required for morcellation).
Morcellation time will be measured by a theatre staff nurse.
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Assessment method [4]
340680
0
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Timepoint [4]
340680
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Immediate following surgery
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Secondary outcome [5]
340681
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Peri-operative Hemoglobin (Hb) value deficit. Hb deficit = Hb in first post-operative day - Hb pre-operatively (in patient's pre-assessment, within 2-3 weeks before the procedure).
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Assessment method [5]
340681
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Timepoint [5]
340681
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Hb will be measured pre-operatively and first day post-operatively.
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Secondary outcome [6]
340682
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Length of Hospital Stay in days. This will be assessed by review of hospital records.
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Assessment method [6]
340682
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Timepoint [6]
340682
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In the time of patient's discharge from hospital.
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Eligibility
Key inclusion criteria
Patients that will undergo HoLEP for Bladder Outlet Obstruction (BOO) symptoms, acute or chronic retention of Urine.
Male.
Age higher or equal of 40 years old.
Preoperative prostate volume < 120cc.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients that will undergo only median lobe enucleation
Previous prostatic operation excluding BNI (bladder neck incision)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/2018
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Actual
4/06/2018
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Date of last participant enrolment
Anticipated
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Actual
31/05/2019
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Date of last data collection
Anticipated
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Actual
6/01/2020
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
9365
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United Kingdom
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State/province [1]
9365
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Essex. Southend University Hospital
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Funding & Sponsors
Funding source category [1]
298021
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Hospital
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Name [1]
298021
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Southend University Hospital
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Address [1]
298021
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Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY
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Country [1]
298021
0
United Kingdom
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Primary sponsor type
Individual
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Name
Spyridon Kampantais
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Address
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
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Country
United Kingdom
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Secondary sponsor category [1]
297097
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None
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Name [1]
297097
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None
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Address [1]
297097
0
None
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Country [1]
297097
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299056
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Clinical Audit Department, Southend University Hospital
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Ethics committee address [1]
299056
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Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
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Ethics committee country [1]
299056
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United Kingdom
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Date submitted for ethics approval [1]
299056
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01/12/2017
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Approval date [1]
299056
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30/01/2018
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Ethics approval number [1]
299056
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17265
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Summary
Brief summary
It is well known, that Holmium Laser Enucleation of Prostate (HoLEP) is laser treatment for benign prostatic hyperplasia (BPH) with many advantages in comparison with transurethral resection of prostate (TURP) and open prostatectomy. Despite this, the shallow learning curve has hindered its wide adoption among urologists. Many studies have previously assessed the learning curve of this difficult endourological procedure, both in a retrospective, as well as in a prospective manner. Different outcome measures were used in these studies, showing varying case-loads to reach a plateau. In general, a number approximating 50 cases is the consensus of the literature regarding the learning curve of this operation. However, only one study assessed the surgeon’s stress during this operation and this was done using a simply way, a stress score calculated with a Visual Analogue Scale (VAS).
The aim of this study is to assess and quantify the learning experience of a single surgeon following the Holmium User Group (HUG) HoLEP mentorship programme (HUG-MP), during the initial learning curve of holmium laser enucleation of the prostate (HoLEP).
Primary outcomes will be the surgical efficiency and surgeon’s stress levels during the operation. Surgical efficiency will be measured with enucleation efficiency
(weight of enucleated tissue divided by lasing time) and laser to prostate ratio (L/P ratio; amount of consumed laser energy divided by retrieved prostate tissue weight). Stress during HoLEP will be assessed by measuring heart rate of the surgeon with an armband heart rate monitor and by the surgeon himself, using a self-evaluation questionnaire immediately after the procedure, the state-trait anxiety inventory for adults (STAI Form Y-1).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
79134
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Mr Spyridon Kampantais
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Address
79134
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Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
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Country
79134
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United Kingdom
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Phone
79134
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+44 790 4493534
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Fax
79134
0
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Email
79134
0
[email protected]
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Contact person for public queries
Name
79135
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Mr Spyridon Kampantais
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Address
79135
0
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
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Country
79135
0
United Kingdom
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Phone
79135
0
+44 790 4493534
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Fax
79135
0
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Email
79135
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[email protected]
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Contact person for scientific queries
Name
79136
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Mr Spyridon Kampantais
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Address
79136
0
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
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Country
79136
0
United Kingdom
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Phone
79136
0
+44 790 4493534
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Fax
79136
0
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Email
79136
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
10624
Statistical analysis plan
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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