Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06038890 |
| Other study ID # |
Mans.9.2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Despite the high-quality evidence supporting the safety and efficacy of Holmium laser
enucleation of the prostate (HOLEP), wide adoption of the procedure is hindered by learning
difficulties. Veil-sparing HOLEP was popularized with a standardized approach to learning.
Prospective multicenter assessment of the learning curve of HoLEP through a novel technique
with structured learning protocol.
Learning outcome measures will be assessed against time and number of performed cases of new
learners in a multicenter study.
Description:
INTRODUCTION Holmium laser enucleation of the prostate (HoLEP) was described in 1998 1 and
since then, it has the highest level of evidence supporting its safety, efficacy and
durability in treating benign prostate hyperplasia (BPH) 2.
Furthermore, it is a cost-effective alternative both in developing3 and developed4 countries.
Nevertheless, learning difficulties hinder wide adoption of this technique among urologists
and even more some centers discontinue doing this technique due complications encountered
early in the learning curve5.
Performance of a task repetitively changes with experience over time. Plotting performance
(outcome measures) against experience (number of performed tasks) produces a learning curve.
Improvement tends to be rapid at first and then tails off over time until a steady state is
reached (Plateau) 6. Time-To-Plateau (TTP); number of HoLEP tasks is variably reported;
20-307-9, 5010 or even more procedures were reported as time needed to reach steady state
(plateauing).
Elshal et al in 2023 compared this novel veil sparing approach in a comparitve study with the
standard HOLEP approach and concluded that the veil sparing approach was associated with
better short term urine continence.11 In this work we aim at assessment of the learning curve
using this novel technique (Veil sparing HOLEP).
In this study, this novel technique is proposed to shorten the time to plateau (steady state)
in mainly safety and efficiency outcome measures of HOLEP.
RATIONAL
Despite the high-quality evidence supporting the safety and efficacy of HOLEP, wide adoption
of the procedure is hindered by learning difficulties. Veil-sparing HOLEP was popularized
with a standardized approach for learning.
RESEARCH QUESTION Will Veil sparing Holmium laser enucleation with its standardized approach
to learning cut short the learning curve?
HYPOTHESIS Veil-sparing Holmium laser enucleation of the prostate is feasible, and efficient,
with a shorter learning curve.
AIM OF THE WORK We aim at assessment of the learning curve using this novel technique (Veil
sparing HOLEP) In this study, this novel technique is proposed to shorten the time to plateau
(steady state) in mainly safety and efficiency outcome measures of HOLEP.
PATIENTS AND METHODS
A. Study design:
Design: A Prospective multicenter cohort study. Sample size: Assuming that all cases met the
inclusion and exclusion criteria will be included. During the study period (12 months), 4
cases/ month.48 cases will be included as a comprehensive sample.
Study population: eligible patients from our outpatient clinic, who are indicated for
transurethral surgery for BPO will be screened for inclusion and exclusion criteria and will
be offered informed consent.
B. Procedure:
1. Preoperative evaluation
All patients will be subjected to:
Written informed consent will be obtained from all patients Clinical history taking
including International prostate symptom score (IPSS) and Quality of life (QoL).
Physical and clinical examination Transrectal ultrasound (TRUS) to assess the prostate
volume. PVRU by Pelvi-abdominal U/S (PA us). Uroflowmetry. Urine culture. Pre-operative
routine laboratory investigations including CBC, PT, PTT, INR, liver and kidney
functions.
2. Set-up Endoscopy: At our institution, we use a 26 French (Fr) continuous flow
resectoscope with a laser bridge adapter and an endoscopic camera. The laser bridge
adapter stabilizes the laser fiber and fixes it at the 6'oclock position on the
endoscope. This set up helps keep the laser fiber at a fixed length from the tip of the
endoscope and stabilizes the laser fiber.
Laser machine: we use a 100-Watt holmium laser and an end-firing 550-micron laser fiber
with energy settings of 2.0 J and frequency settings of 50 Hz.
For tissue morcellation, a 26 Fr offset nephroscope is used along with a transurethral
soft-tissue morcellator. The morcellator consists of two 5 mm reciprocating hollow metal
blades, a hand-piece, a two-phase foot pedal, and a control box. The control box
consists of a motor unit that powers the blades and supplies suction for tissue removal.
A tissue collection device collects the chips as they are suctioned out of the bladder.
3. Points of the HOLEP technique Veil sparring HOLEP was performed in stepwise approach
abbreviated for sake of learning as (IT PAS ABCD).11 Inspection of the prostate
morphology looking for the main landmarks including the verumontanum, apical bulge,
bladder neck and the ureteral orifices.
Incision of the prostate from the bladder neck to the verumontanum. The principle of the
incision is to touch with the laser fiber and keep pressing the prostatic tissue using the
scope.
Trough creation: the idea of trough creation is to create a working channel wider between the
bladder neck and the verumontanum by hugging and pressing against the lateral lobes and
trying to incise underneath each of them Plain development: the Incision is extended lateral
to the verumontanum just mucosal incision following the apical bulge. Once the mucosal
incision is completed, the laser fiber is withdrawn and using the tip of the scope bluntly
enucleating the lateral lobes developing a plain between the surgical capsule and the
prostatic adenoma.
Apico-lateral dissection: at this step the scope will be rotated 180 degrees where the laser
fiber will come at 12 o'clock position, then compound sharp and blunt dissection of the
prostatic adenoma from the prostatic surgical capsule progressing laterally trying to
insinuate the scope between the surgical capsule and the prostatic adenoma.
Sphincter liberation (strip cutting): at this step, the scope will be gradually withdrawn out
of the prostatic fossa looking for the sphincteric ring. Once the sphincteric ring is
identified, we move the scope proximal to the ring to start cutting from 12 o'clock position
towards the plain we previously created. We keep cutting only the mucosa we keep hugging the
adenoma pressing on it trying to leave the veil of mucosa covering the sphincter ring.
Anterior dissection and commissurotomy: in this step we aim at creating an anterior plain
connecting the laterally created plain to the anterior commissure. So, we keep curving
anterior to the adenoma till we start anterior commissurotomy. Once the scope is riding the
adenoma, we progress to the bladder neck connecting the lateral created plain to the anterior
commissure cutting and sharply dissecting all residual attachment of the prostatic adenoma to
the surgical capsule.
Bladder neck dissection: we start bladder neck dissection at 12 o'clock position where we
start cutting anterior to the adenoma from the 12 o'clock position progressing laterally till
10 o'clock position.
C-shaped baso-lateral dissection: in this step we start sharp dissection cutting all around
the adenoma in a c-shaped fashion progressively from the 10 o'clock position on the right
lateral lobe towards the 7 o'clock position. This step entails circumferential dissection of
the bladder neck fibers. The end of the c-shaped baso-lateral dissection is the
identification of the ureteral orifices.
Detachment of the adenoma after its flipping inside the bladder: in this step we keep
pressing the adenoma from underneath and lateral towards the bladder neck till the adenoma is
flipped inside the bladder. Once the adenoma is flipped inside the bladder it will stretch
its basal attachment so it is easier to be cut using the laser fiber from lateral to medial.
The other prostatic lobe will be enucleated in a similar way starting by Incision in front of
the verumontanum with extension of the Incision following the apical bulge and later blunt
enucleation.
The procedure will be concluded by tissue morcellation with extraction of the enucleated
prostatic tissue.
Lastly carful inspection of the prostatic fossa, sphincteric ring covered by mucosal veil all
around and anterior. Careful hemostasis will be done before ending the procedure.
Hemostasis is very good with this technique; however persistent small bleeders should be
coagulated prior to morcellation. Coagulation is accomplished by defocusing the laser energy
off any bleeding tissue. The desired result is that the tissue will blanch and stop bleeding.
Tissue morcellation The first step in tissue morcellation is to ensure the bladder is full. A
26 Fr offset nephroscope with the soft-tissue morcellator is inserted into the bladder. The
blades of the morcellator should be placed in the center of the bladder away from the bladder
mucosa. The two-phase foot pedal is then depressed to engage the suction but not the
reciprocating blades. Adenoma is then drawn to the tip of morcellator blades. If the suction
necessary to engage the adenoma will collapse the bladder too quickly, a second inflow tubing
can be attached to the nephroscope outflow channel to increase the inflow and keep the
bladder distended. Once the adenoma is at the tip of the morcellator, the foot pedal is
depressed further, activating the blades, and the adenoma is morcellated, cutting the adenoma
into small pieces that are suctioned out of the bladder and deposited in the collection
chamber. Small pieces of the adenoma should not be chased with the morcellator blades in the
bladder because of the increased risk of bladder injury.
Instead, the small adenomatous tissue should be removed by either a modified resectoscope
loop, a rigid grasper for the nephroscope, Ellik evacuator or glass Toomey syringe. Once all
chips are removed a 24 Fr three-way Foley catheter is inserted and bladder irrigation is
instituted if needed.
Postoperative care If continuous bladder irrigation is used then usually it is continued only
overnight. In the am of postoperative day 1 the bladder irrigation is discontinued once the
hematuria stopped, and patients are given a trial of void. If they fail the trial of void,
they are discharged home on postoperative day 1 with an 18 Fr Coude catheter for 3-5 days.
Follow-up assessment included CBC for Hb loss immediately postoperatively. Urine analysis (±
culture if indicated), IPSS, QoL, Qmax and PVRU assessment after 1, 4 and 12 months
post-operatively. PSA level will be tested at 4 months and then annually unless otherwise
indicated.
In each visit, patients were verbally interrogated if they experience any episodes of urine
incontinence (UI) and its associated condition as coughing or with certain movements; (SUI)
stress urine incontinence, urgency; (UUI) urge urine incontinence or mixed UI. Any patient
reported prolonged UI to 4 months or persistent at 12 months, was examined by standardized
one-hour pad test. Grade of UI was objectively reported as grade (zero-4)12.
Outcome measures:
A) Operative efficacy measures include; enucleation efficiency (retrieved prostate tissue
weight divided by enucleation time), operative efficiency (retrieved prostate tissue weight
divided by total operative time) and laser to prostate ratio (L/P ratio; amount of consumed
laser energy divided by retrieved prostate tissue weight).
B) Postoperative efficacy measures include; percent reduction of postoperative PSA. Median
value of PSA levels at 4 and 12 months was used as postoperative PSA. Percent reduction was
used as a surrogate marker of postoperative reduction in prostate volume.
C) Operative safety measures include; capsule violation, bladder wall injury (superficial or
deep) and intraoperative bleeding necessitating blood transfusion or conversion to TURP.
Moreover, perioperative hemoglobin and hematocrit value deficit (preoperative minus immediate
postoperative value) were depicted.
D) Catheter duration, hospital stay and postoperative safety measures include 30-days
postoperative complications.
E) Urinary flow outcome measures include IPSS, QOL (quality of life), Qmax (Peak flow rate)
and PVR.
F) Urinary continence status at each follow-up visits using ICIQ-UI-SF Questionnaire and one
hour pad test.
G) Need for reoperation for recurrent infravesical obstruction will be depicted.
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combined with mechanical morcellation: preliminary results. Eur Urol, 33: 69, 1998
2. Cornu, J. N., Ahyai, S., Bachmann, A. et al.: A Systematic Review and Meta- analysis of
Functional Outcomes and Complications Following Transurethral Procedures for Lower
Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update Eur Urol,
2014
3. Elshal, A. M., Mekkawy, R., Laymon, M. et al.: Holmium laser enucleation of the prostate
for treatment for large-sized benign prostate hyperplasia; is it a realistic
endourologic alternative in developing country? World J Urol, 2015
4. Salonia, A., Suardi, N., Naspro, R. et al.: Holmium laser enucleation versus open
prostatectomy for benign prostatic hyperplasia: an inpatient cost analysis. Urology, 68:
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the learning curve of holmium laser enucleation of the prostate (HoLEP). BJU Int, 2015
6. Hopper, A. N., Jamison, M. H., Lewis, W. G.: Learning curves in surgical practice.
Postgrad Med J, 83: 777, 2007
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long-term results, reoperation rate, and possible impact of the learning curve. Eur
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efficacy, and learning experience in China. J Endourol, 22: 1031, 2008
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the prostate: a single-center experience. Korean J Urol, 51: 688, 2010
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11. Ahmed Elshal, Mostafa Ghazy, Mahmoud Laymon, Fady Kamal V07-03 VEIL SPARRING HOLMIUM
LASER ENUCLEATION OF THE PROSTATE; TECHNICAL EVOLUTION AND PRELIMINARY RESULTS OF
RANDOMIZED TRIAL, Journal of Urology: April 2023 - Volume 209 - Issue Supplement 4 doi:
10.1097/JU.0000000000003288.03
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