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Holmium Laser En-Bloc Resection Versus Conventional Transurethral Resection of Bladder Tumors for Treatment of Non-muscle- Invasive Bladder Cancer

NCT07534631 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-16

No results posted yet for this study

Summary

This study is a prospective randomized controlled trial comparing holmium laser en-bloc resection of bladder tumor (HoLERBT) with conventional transurethral resection of bladder tumor (cTURBT) in patients with suspected non-muscle-invasive bladder cancer (NMIBC).

A total of 100 patients will be randomly assigned in a 1:1 ratio to undergo either HoLERBT or cTURBT. The primary outcome is the quality of the pathological specimen, assessed by the presence of detrusor muscle. Secondary outcomes include perioperative complications, operative time, obturator nerve reflex, bladder perforation, positive surgical margins, persistent disease at second-look TURBT, and recurrence rates at 3 and 12 months, as well as recurrence-free survival.

This study aims to evaluate whether HoLERBT provides superior resection quality and improved clinical outcomes compared to conventional TURBT.

Conditions

  • Bladder Tumor (TURBT)

Interventions

PROCEDURE

Holmium Laser En-Bloc Resection of Bladder Tumor

Holmium laser en-bloc resection of bladder tumor (HoLERBT) is a surgical technique in which the bladder tumor is removed in a single piece using a holmium laser. The procedure allows precise dissection, improved hemostasis, and better preservation of specimen integrity for pathological assessment.

PROCEDURE

Conventional Transurethral Resection of Bladder Tumor

Conventional transurethral resection of bladder tumor (cTURBT) is a standard surgical procedure in which the tumor is removed in multiple fragments using a monopolar or bipolar resectoscope.

Sponsors & Collaborators

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-05
Primary Completion
2025-10-05
Completion
2026-01-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534631 on ClinicalTrials.gov