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

Beni-Suef University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Bladder Tumor (TURBT)

Interventions

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.

Conventional Transurethral Resection of Bladder TumorPROCEDURE

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.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged 30 years or older. * Patients with cystoscopically suspected primary NMIBC planned for endoscopic resection. * Fit for surgery and anesthesia. * Able and willing to provide written informed consent and comply with follow-up. Exclusion Criteria: * Muscle-invasive disease suspected preoperatively or evidence of metastatic disease. * Prior bladder radiotherapy. * Severe comorbidity precluding surgery. * Pregnancy. * Inability to provide informed consent. * Upper urinary tract urothelial carcinoma or life expectancy less than 1 year

Locations (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suef Governorate, Egypt

Outcomes

Primary Outcomes

Presence of Detrusor Muscle in Resected Specimen

Assessment of the quality of tumor resection based on the presence of detrusor muscle in the histopathological specimen obtained after surgery.

Time frame: Immediately after surgery (postoperative histopathological assessment)

Secondary Outcomes

Intraoperative Complications

Incidence of intraoperative complications including obturator nerve reflex, intraoperative bleeding, and bladder perforation.

Time frame: During surgery

Tumor Recurrence at 3 Months

Incidence of bladder tumor recurrence at 3 months follow-up.

Time frame: 3 months after surgery

Data from ClinicalTrials.gov

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