Non-muscle Invasive Bladder Cancer, Urinary Bladder Neoplasms
Conditions
Keywords
Transurethral Resection of Bladder Tumor, En Bloc Resection, Conventional Transurethral Resection, Tumor Recurrence
Brief summary
Bladder cancer that has not invaded the bladder muscle often returns after treatment, creating repeated procedures and ongoing anxiety for patients. The standard initial treatment is transurethral resection of bladder tumour (TURBT), in which visible tumours are removed through a telescope passed into the bladder. Conventional TURBT usually removes the tumour in multiple pieces, which may reduce specimen quality for laboratory assessment and may increase the chance that small tumour fragments remain or spread during removal. En bloc TURBT is a newer technique that aims to remove the tumour in one intact piece, which may improve the quality of the tissue specimen for accurate staging and grading, allow better assessment of surgical margins, and potentially reduce recurrence. This randomized controlled trial was conducted in the Department of Urology, Lahore General Hospital and PGMI, Lahore. A total of 116 adults (18 to 60 years) with non-muscle invasive bladder cancer were enrolled and randomly assigned to en bloc TURBT or conventional TURBT (58 patients per group). Resected specimens were evaluated by pathologists who was not be informed of the surgical technique. The study was compare key pathological outcomes, including the presence of detrusor muscle in the specimen, histological grade, tumour stage accuracy, specimen integrity, and the ability to assess lateral and deep resection margins. Participants were followed for 15 months, with surveillance at 3-month intervals.
Interventions
PROCEDUREEn Bloc Transurethral Resection of Bladder Tumor
Complete en bloc endoscopic resection of a non-muscle invasive bladder tumour (≤1.5 cm) as one piece, aiming to preserve specimen integrity and allow assessment of deep and lateral margins.
Piecemeal endoscopic resection of a non-muscle invasive bladder tumour by removing the lesion in multiple pieces, as per standard conventional technique.
Sponsors
Lahore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Both male and female patients between 18 years and 60 years of age. * Patients diagnosed with non-muscle invasive bladder cancer (NMIBC). * Willingness to participate in the study, as indicated by signed informed consent.
Exclusion criteria
* Patients with muscle-invasive bladder cancer (MIBC) or metastatic disease. * Previous history of bladder cancer treatment, including surgical resection or chemotherapy. * Patients with contraindications to anesthesia or those unable to undergo TURBT due to medical reasons. iv. Individuals who have not provided informed consent or are unable to comply with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Recurrence Rate | Up to 15 months after surgery, assessed at 3, 6, 9, 12 and 15 months | Proportion of participants with histologically confirmed recurrence of non-muscle invasive bladder cancer detected by cystoscopy and biopsy after complete initial resection. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr Ijaz
Lahore General Hospital, Lahore
Outcome results
None listed