NCT07890103|RecruitingDMC
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Comparison of the Learning Curves of Tri-lobar Versus En-bloc Holmium Laser Enucleation of the Prostate: A Prospective Randomized Clinical Trial
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Comparison of the Learning Curves of Tri-lobar Versus En-bloc Holmium Laser Enucleation of the Prostate: A Prospective Randomized Clinical Trial
Sponsor study identifier
interventional
120
1 country
1
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Several HoLEP techniques have been developed, with the conventional tri-lobar and the en-bloc approaches being the most commonly practiced. Although both techniques achieve comparable functional outcomes and safety profiles, they differ in surgical dissection strategy and anatomical orientation. Some authors suggest that the en-bloc technique may facilitate maintenance of the correct surgical plane, whereas others consider the tri-lobar approach easier for surgeons familiar with transurethral resection of the prostate (TURP). However, evidence comparing their learning characteristics remains limited. Most published studies evaluating the HoLEP learning curve have investigated a single surgical technique or assessed a second technique after surgeons had already gained substantial HoLEP experience. Such study designs introduce significant bias because increasing surgical experience inevitably influences subsequent performance. A prospective alternating design, in which a HoLEP-naïve surgeon performs consecutive tri-lobar and en-bloc procedures, may provide a more balanced comparison by exposing both techniques to similar levels of cumulative surgical experience while minimizing temporal bias.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 13, 2026
Actual (reported)October 22, 2026
Actual (reported)October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of cases required to achieve procedural proficiency
Number of cases required to achieve procedural proficiency, defined by a sustained plateau in enucleation efficiency (enucleated weight in gm/operative time in min) determined using RA-CUSUM. Risk-adjusted CUSUM adjusts for: * Prostate size * Operative time (Enucleation time + Morcellation time) * Enucleated weight
1 year
Enucleation time
1 year
Morcellation time
1 year
Enucleated weight
1 year
endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as 3 specimens (median lobe and 2 lateral lobes) using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser
endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as a single, intact specimen using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser
Faculty of Medicine, Tanta University
Tanta, Egypt
First Submitted
October 13, 2026
First Posted
October 22, 2026
Study Start
October 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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October 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 22, 2026
Record last verified: 2026-10
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