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NCT07890103
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Conditions: Benign Prostatic Hyperplasia With Outflow Obstruction
Sex: Male
Ages: 50 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: Tanta University
Location: Faculty of Medicine, Tanta University Tanta
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* BPH requiring HoLEP
* Prostate 80-150 cc
* Performed by surgeons with no previous independent experience in the evaluated techniques
Exclusion Criteria:
* Previous prostate surgery
* Neurogenic bladder
* Prostate cancer
* Simultaneous bladder surgery
* Extremely large prostates (\>150 cc)
Source: ClinicalTrials.gov (NCT07890103). StuddyBuddy aggregates publicly available trial information.