HoLEP: Learning Curve Analysis and Comparison With TURP
NCT ID: NCT06849089
Last Updated: 2025-02-28
Study Results
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Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2022-06-01
2024-12-30
Brief Summary
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Detailed Description
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LUTS due to BPO can be managed through conservative measures, pharmacological treatments, or surgical interventions. While conservative and pharmacological therapies offer temporary, symptom-based relief, surgical treatments aim to provide a more permanent solution. Transurethral resection of the prostate (TURP) has been the gold standard surgical treatment for BPO for many years. However, advances in laser technology and surgical techniques have led to the increased popularity of anatomical endoscopic enucleation of the prostate (AEEP) using lasers such as holmium yttrium-aluminum-garnet (YAG), thulium YAG, or thulium fiber laser in the past decade. HoLEP is quite versatile in achieving complete anatomic enucleation of prostate adenoma which provides a permanent relief of obstruction and prevents re-growth of remnant prostatic tissue.
The scientific evidence supports the superiority of HoLEP compared to TURP, which has long been the gold standard. However, HoLEP is not an easy surgical method to learn and expertise. The learning curve is a critical consideration in HoLEP, which requires significant technical skill and experience to achieve proficiency and optimal outcomes. Perioperative and postoperative variables are evaluated to assess surgeon performance over consecutive cases.
The learning curve has been reported to be variable in different studies showing results between 25 to 80 cases in different cohorts.
In this study, we aimed to evaluate the outcomes of HoLEP during both the learning curve and expert periods, and to compare these results with the long-established gold standard, TURP.
METHODS Eligible patients were men \>50 years of age presenting to our outpatient clinic with LUTS attributed to BPO with an indication for surgical treatment according to EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms 14 and who underwent either TURP or HoLEP. Patients with a prior history of BPE surgery, history of prostate cancer diagnosis were excluded.
Patients who underwent HoLEP by a single surgeon were included in the study. HoLEP patients were divided into 2 groups. The initial 50 patients who underwent HoLEP were considered to be operated in the learning curve of the surgeon. The subsequent 50 patients who underwent HoLEP by the same surgeon were considered to be operated in the expert phase of the surgeon. For comparison with the TURP outcomes, the last 100 patients who underwent bipolar TURP by the same surgeon were included in the study.
TURP patients were grouped as Group 1, initial 50 HoLEP patients were grouped as Group 2 and the subsequent 50 HoLEP patients were grouped as Group 3.
Patients who had a urinary tract infection prior to surgery were treated with appropriate antibiotics according to the preoperative urine culture. All the patients were scheduled for surgery when a sterile urine culture was obtained. All the patients received second generation cephalosporins as prophylactic antibiotics prior to surgery according to the local institution's Infections Committee protocol. Bridging with low molecular weight heparin was performed for all the patients who were under anticoagulant or antiaggregant therapies.
The primary objective was to evaluate the success rate. The evaluated parameters were scores on International Prostate Symptom Score (IPSS) and Quality of Life (QoL) questionnaire, maximum urinary flow rate (Qmax) on uroflowmetry and post-void residual urine volume (PVR) and operation duration, surgical efficiency and learning curve of HoLEP using the Cumulative Sum (CUSUM) analysis, for which, enucleation efficiency was used as evaluated parameters.
The secondary objective was to evaluate the safety profile by comparing the postoperative complications.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1 - TURP patients
The last 100 patients who underwent bipolar TURP by the same surgeon who performed the HoLEP procedures in the study.
Transurethral resection of prostate (TURP)
The surgical intervention used to resect the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a hot loop shaped knife, operated by electrocautery, to cut the obstructing tissues from center towards periphery of the prostate until the prostatic capsule is reached.
Group 2 - Initial HoLEP patients
The initial 50 patients who underwent HoLEP, who were considered to be operated in the learning curve of the surgeon.
Holmium laser enucleation of prostate
The surgical intervention used to enucleate the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a laser fiber to dissect the obstructing adenoma from the prostatic capsule starting from the plane in-between the capsule and the adenoma, meaning removal of tissues from periphery towards the center of the prostate.
Group 3 - Subsequent HoLEP patients
The subsequent 50 patients who underwent HoLEP, who were considered to be operated in the expert phase of the surgeon.
Holmium laser enucleation of prostate
The surgical intervention used to enucleate the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a laser fiber to dissect the obstructing adenoma from the prostatic capsule starting from the plane in-between the capsule and the adenoma, meaning removal of tissues from periphery towards the center of the prostate.
Interventions
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Transurethral resection of prostate (TURP)
The surgical intervention used to resect the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a hot loop shaped knife, operated by electrocautery, to cut the obstructing tissues from center towards periphery of the prostate until the prostatic capsule is reached.
Holmium laser enucleation of prostate
The surgical intervention used to enucleate the benign adenomatous hyperplastic nodules of the prostate that cause obstruction and consequently lower urinary tract symptoms. The procedure uses a laser fiber to dissect the obstructing adenoma from the prostatic capsule starting from the plane in-between the capsule and the adenoma, meaning removal of tissues from periphery towards the center of the prostate.
Eligibility Criteria
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Inclusion Criteria
* presenting to our outpatient clinic with lower urinary tract symptoms attributed to benign prostatic obstruction
* indication for surgical treatment according to EAU Guidelines on Non-Neurogenic Male Lower Urinary Tract Symptoms
Exclusion Criteria
* history of prostate cancer diagnosis
50 Years
MALE
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Tarik Emre Sener
Associate Professor of Urology.
Principal Investigators
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Tarık EMre Sener, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Marmara University, School of Medicine, Department of Urology
Locations
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Marmara University, School of Medicine, Department of Urology
Istanbul, Pendik, Turkey (Türkiye)
Countries
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References
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Tang J, Yang JC, Zhang Y, Liu X, Zhang L, Wang Z, Li J, Luo Y, Xu J, Shi H. Does benign prostatic hyperplasia originate from the peripheral zone of the prostate? A preliminary study. BJU Int. 2007 Nov;100(5):1091-6. doi: 10.1111/j.1464-410X.2007.07081.x.
Chughtai B, Forde JC, Thomas DD, Laor L, Hossack T, Woo HH, Te AE, Kaplan SA. Benign prostatic hyperplasia. Nat Rev Dis Primers. 2016 May 5;2:16031. doi: 10.1038/nrdp.2016.31.
Dahm P, Brasure M, MacDonald R, Olson CM, Nelson VA, Fink HA, Rwabasonga B, Risk MC, Wilt TJ. Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis. Eur Urol. 2017 Apr;71(4):570-581. doi: 10.1016/j.eururo.2016.09.032. Epub 2016 Oct 4.
Plochocki A, King B. Medical Treatment of Benign Prostatic Hyperplasia. Urol Clin North Am. 2022 May;49(2):231-238. doi: 10.1016/j.ucl.2021.12.003. Epub 2022 Mar 22.
Cornu JN, Zantek P, Burtt G, Martin C, Martin A, Springate C, Chughtai B. Minimally Invasive Treatments for Benign Prostatic Obstruction: A Systematic Review and Network Meta-analysis. Eur Urol. 2023 Jun;83(6):534-547. doi: 10.1016/j.eururo.2023.02.028. Epub 2023 Mar 22.
Franco JVA, Jung JH, Imamura M, Borofsky M, Omar MI, Escobar Liquitay CM, Young S, Golzarian J, Veroniki AA, Garegnani L, Dahm P. Minimally invasive treatments for benign prostatic hyperplasia: a Cochrane network meta-analysis. BJU Int. 2022 Aug;130(2):142-156. doi: 10.1111/bju.15653. Epub 2021 Dec 6.
He W, Ding T, Niu Z, Hao C, Li C, Xu Z, Jing Y, Qin W. Reoperation after surgical treatment for benign prostatic hyperplasia: a systematic review. Front Endocrinol (Lausanne). 2023 Nov 9;14:1287212. doi: 10.3389/fendo.2023.1287212. eCollection 2023.
Magistro G, Schott M, Keller P, Tamalunas A, Atzler M, Stief CG, Westhofen T. Enucleation vs. Resection: A Matched-pair Analysis of TURP, HoLEP and Bipolar TUEP in Medium-sized Prostates. Urology. 2021 Aug;154:221-226. doi: 10.1016/j.urology.2021.04.004. Epub 2021 Apr 21.
Mavuduru RM, Mandal AK, Singh SK, Acharya N, Agarwal M, Garg S, Kumar S. Comparison of HoLEP and TURP in terms of efficacy in the early postoperative period and perioperative morbidity. Urol Int. 2009;82(2):130-5. doi: 10.1159/000200786. Epub 2009 Mar 19.
Chavali JSS, Rivera ME, Lingeman JE. HoLEP Learning Curve-Resident Perspective: Survey of Senior Residents from High-Volume Tertiary Center. J Endourol. 2024 Sep;38(9):977-981. doi: 10.1089/end.2024.0054. Epub 2024 Jul 4.
Wenk MJ, Hartung FO, Egen L, Netsch C, Kosiba M, Grune B, Herrmann J. The long-term learning curve of holmium laser enucleation of the prostate (HoLEP) in the en-bloc technique: a single surgeon series of 500 consecutive cases. World J Urol. 2024 Jul 24;42(1):436. doi: 10.1007/s00345-024-05097-9.
Martinez-Salas AJ, Garcia-Rivera OU, Reyna-Blanco I, Jimenez-Garcia AD, Rosas-Hernandez H. Adequate Mentorship Program for Holmium Laser Enucleation of the Prostate (HoLEP) Leads to Satisfactory Short-Term Outcomes in the Early Learning Curve of Young Urologists: First-Year Outcomes of a Newly Established Mentorship Training in Mexico. Cureus. 2023 Jul 12;15(7):e41756. doi: 10.7759/cureus.41756. eCollection 2023 Jul.
Baron M, Nouhaud FX, Delcourt C, Grise P, Pfister C, Cornu JN, Sibert L. [HoLEP learning curve: Toward a standardised formation and a team strategy]. Prog Urol. 2016 Sep;26(9):492-9. doi: 10.1016/j.purol.2016.08.002. Epub 2016 Sep 7. French.
Other Identifiers
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MAR.UAD.0020
Identifier Type: -
Identifier Source: org_study_id
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