The impact of avoiding a restage TURBT(Transurethral resection of bladder tumours) in non muscle invasive bladder tumours: A randomized control trial

Patients providing informed consent with bladder tumors fulfilling the inclusion criteria and undergoing an initial TURBT with complete resection with deep muscle included in the specimen will be recruited for participation in this prospective RCT. Completion of TURBT was defined as complete resection of visible tumor. Data Collection: Utilizing a data collection sheet , a systematic collection of data will be done. This will encompass clinical evaluation, including demographic information, relevant medical history, and pathological parameters such as stage, grade, presence of concomitant carcinoma in situ (CIS), number of tumors, and presence of detrusor muscle in the specimen. Basic Investigations: After obtaining written informed consent, participants will undergo a series of basic investigations in accordance with institutional guidelines which are part of routine clinical practice. These include a comprehensive hemogram, renal function test, liver function tests, chest X-ray, and urine culture. Group stratification and randomization: The process of randomization will begin once histopathology report of the primary TUR is obtained. Randomization will be done using a computer-generated randomization schedule using block randomization technique. Sequentially numbered, opaque, sealed envelopes (SNOSE) will be used for 22 allocation concealment. Both the treating surgeon and the patients will be aware of the management proposed. No reTUR arm: Patients with TaHG/T1LG histopathologies will receive intravesical Mitomycin C induction weekly for 6 weeks followed by monthly for 1 year based on AUA guidelines (8). Patients with T1HG histopathology will receive intravesical BCG induction weekly for 6 weeks followed by monthly for 1 year based on AUA guidelines (8). They will be on regular follow-up check cystopanendoscopy (CPE) every three months and urine cytology. The first check CPE will be done under general anaesthesia, so that any residual tumours would be resected in the same sitting. All the check CPE findings will be recorded. In case of a recurrence, patients will undergo a reTUR and the HPE will be recorded followed by standard management as per risk stratification. QOL will be recorded at 6 monthly intervals with the QOL-15 questionnaire. ReTUR arm: Patients will undergo a reTUR within 2 to 6 weeks from the initial TURBT. The cystoscopy findings will be recorded during the reTUR. All reTURs will be performed with a 26French resectoscope with bipolar loop. In patients with no obvious tumors, resection of the tumor bed will be performed and sent for HPE. The HPE reports of all patients will be recorded. After reTUR, the patients will receive the same intravesical therapy and follow up as in the “no reTUR arm” unless there is an upstaging which will be managed according to the AUA guidelines . Study follow-up: One year 5) Ethical Considerations: The study will be conducted in compliance with ethical principles, ensuring patient confidentiality, privacy, and adherence to all relevant ethical guidelines and regulatory requirements.