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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
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.
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.
Secondary ID [1] 293397 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 305542 0
Condition category
Condition code
Renal and Urogenital 304774 304774 0 0
Other renal and urogenital disorders
Surgery 306512 306512 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 299643 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303996 0
Enucleation efficiency
(weight of enucleated tissue divided by lasing time). Lasing time will be extracted automatically by laser device.
Timepoint [1] 303996 0
Immediate following surgery
Primary outcome [2] 303997 0
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.
Timepoint [2] 303997 0
Maximum heart rate during the operation and completion of STAI Form Y-1 at completion of operation.
Primary outcome [3] 304759 0
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.
Timepoint [3] 304759 0
Immediate following surgery
Secondary outcome [1] 340677 0
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.
Timepoint [1] 340677 0
Immediate following surgery
Secondary outcome [2] 340678 0
Percent reduction of PSA (Prostatic Specific Antigen) post HoLEP. The PSA will be measured with Beckmann serum assay.
Timepoint [2] 340678 0
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.
Secondary outcome [3] 340679 0
Complication rates according to Clavien Dindo modified classification.
Timepoint [3] 340679 0
Complications of each procedure, including intra-operative and post-operative will be assessed during hospital stay, 1 month and 3 months post-operatively.
Secondary outcome [4] 340680 0
Morcellation efficiency
(Weight of enucleated tissue divided by time required for morcellation).
Morcellation time will be measured by a theatre staff nurse.
Timepoint [4] 340680 0
Immediate following surgery
Secondary outcome [5] 340681 0
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).
Timepoint [5] 340681 0
Hb will be measured pre-operatively and first day post-operatively.
Secondary outcome [6] 340682 0
Length of Hospital Stay in days. This will be assessed by review of hospital records.
Timepoint [6] 340682 0
In the time of patient's discharge from hospital.

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.
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that will undergo only median lobe enucleation
Previous prostatic operation excluding BNI (bladder neck incision)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2018
Actual
4/06/2018
Date of last participant enrolment
Anticipated
Actual
31/05/2019
Date of last data collection
Anticipated
Actual
6/01/2020
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 9365 0
United Kingdom
State/province [1] 9365 0
Essex. Southend University Hospital

Funding & Sponsors
Funding source category [1] 298021 0
Hospital
Name [1] 298021 0
Southend University Hospital
Country [1] 298021 0
United Kingdom
Primary sponsor type
Individual
Name
Spyridon Kampantais
Address
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Country
United Kingdom
Secondary sponsor category [1] 297097 0
None
Name [1] 297097 0
None
Address [1] 297097 0
None
Country [1] 297097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299056 0
Clinical Audit Department, Southend University Hospital
Ethics committee address [1] 299056 0
Ethics committee country [1] 299056 0
United Kingdom
Date submitted for ethics approval [1] 299056 0
01/12/2017
Approval date [1] 299056 0
30/01/2018
Ethics approval number [1] 299056 0
17265

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79134 0
Mr Spyridon Kampantais
Address 79134 0
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Country 79134 0
United Kingdom
Phone 79134 0
+44 790 4493534
Fax 79134 0
Email 79134 0
kabspir@hotmail.com
Contact person for public queries
Name 79135 0
Spyridon Kampantais
Address 79135 0
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Country 79135 0
United Kingdom
Phone 79135 0
+44 790 4493534
Fax 79135 0
Email 79135 0
kabspir@hotmail.com
Contact person for scientific queries
Name 79136 0
Spyridon Kampantais
Address 79136 0
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Country 79136 0
United Kingdom
Phone 79136 0
+44 790 4493534
Fax 79136 0
Email 79136 0
kabspir@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10624Statistical analysis plan  kabspir@hotmail.com



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.