Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP

November 2, 2026 updated by: Mahmoud Elrefaey, Tanta University

Comparison of the Learning Curves of Tri-lobar Versus En-bloc Holmium Laser Enucleation of the Prostate: A Prospective Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Faculty of Medicine, Tanta University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tri-lobar HoLEP
Procedure: Tri-lobar HoLEP

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
Experimental: En-bloc HoLEP
Procedure: En-bloc HoLEP

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases required to achieve procedural proficiency
Time Frame: 1 year

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Enucleation time
Time Frame: 1 year
1 year
Morcellation time
Time Frame: 1 year
1 year
Enucleated weight
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 13, 2026

First Submitted That Met QC Criteria

October 20, 2026

First Posted (Actual)

October 22, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 36265PR227/9/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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