Comparison of Pathological Outcome and Recurrence Rate Between En Bloc and Conventional Transurethral Resection of Bladder Tumor

Lahore General Hospital

Status: Completed

Conditions: Non-muscle Invasive Bladder Cancer; Urinary Bladder Neoplasms

Treatments: Procedure: En Bloc Transurethral Resection of Bladder Tumor; Procedure: Conventional Transurethral Resection of Bladder Tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT07347132

LahoreGeneralH12

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

116 participants in 2 patient groups

En Bloc Transurethral Resection of Bladder Tumor (En Bloc TURBT)

Experimental group

Description:

Participants were undergo complete removal of the bladder tumour as a single intact specimen (en bloc), including both exophytic and endophytic components, for tumours up to 1.5 cm in size.

Treatment:

Procedure: En Bloc Transurethral Resection of Bladder Tumor

Conventional Transurethral Resection of Bladder Tumor (Conventional TURBT)

Active Comparator group

Description:

Participants were undergo conventional piecemeal transurethral resection of the bladder tumour, in which the tumour is removed in multiple fragments.

Treatment:

Procedure: Conventional Transurethral Resection of Bladder Tumor