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

NCT07347132 | Completed

• 1 other identifier: LahoreGeneralH12
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Bladder Neoplasms; Non-muscle Invasive Bladder Cancer

Keywords

Transurethral Resection of Bladder Tumor; En Bloc Resection; Conventional Transurethral Resection; Tumor Recurrence

Outcome Measures

Primary Outcomes (1)

• Tumor Recurrence Rate

  Proportion of participants with histologically confirmed recurrence of non-muscle invasive bladder cancer detected by cystoscopy and biopsy after complete initial resection.

  Up to 15 months after surgery, assessed at 3, 6, 9, 12 and 15 months

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: En Bloc Transurethral Resection of Bladder Tumor

Conventional Transurethral Resection of Bladder Tumor (Conventional TURBT)

ACTIVE COMPARATOR

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

Procedure: Conventional Transurethral Resection of Bladder Tumor

Interventions

En Bloc Transurethral Resection of Bladder Tumor PROCEDURE

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.

Also known as: En bloc resection of bladder tumour (ERBT)

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

Conventional Transurethral Resection of Bladder Tumor PROCEDURE

Piecemeal endoscopic resection of a non-muscle invasive bladder tumour by removing the lesion in multiple pieces, as per standard conventional technique.

Also known as: Conventional transurethral resection of bladder tumour (cTURBT)

Conventional Transurethral Resection of Bladder Tumor (Conventional TURBT)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Ijaz

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: September 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

PA (1)