Bladder Tumor (TURBT)
Conditions
Brief 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.
Interventions
PROCEDUREHolmium 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.
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
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Detrusor Muscle in Resected Specimen | Immediately after surgery (postoperative histopathological assessment) | Assessment of the quality of tumor resection based on the presence of detrusor muscle in the histopathological specimen obtained after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Complications | During surgery | Incidence of intraoperative complications including obturator nerve reflex, intraoperative bleeding, and bladder perforation. |
| Tumor Recurrence at 3 Months | 3 months after surgery | Incidence of bladder tumor recurrence at 3 months follow-up. |
Countries
Egypt
Outcome results
None listed