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Immediate second surgery for bladder tumors

Immediate second resection versus re-stage transurethral resection of bladder tumor: A randomized, non-inferiority trial - IMMERSE

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048778
Enrollment
170
Registered
2023-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: TURBT with additional deep biopsy: During 1st TURBT, an additional biopsy will be taken after completing the procedure from tumor base and edge Control Intervention1: Standard TURBT: Du

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing TURBT who achieve complete resection of primary bladder tumor. 2. Aged = 18 years 3. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Non regional lymph node or distant metastasis on cross sectional imaging/ Chest X ray 2. Incomplete resection or deep biopsy not taken (in anticipation of radical cystectomy) 3. Clinical stage =cT3 4. Single recurrent tumor less than 1cm in size with previous low-grade histology 5. Perforation during TURBT or abandonment of procedure for any reason 6. Patients with severe comorbidities (American Society of Anesthesiologists Score >3) 7. Pregnant or lactating patients

Design outcomes

Primary

MeasureTime frame
To compare the adequacy of staging/resection in terms of detrusor muscle (DM) sampling obtained during immediate second resection versus standard re TURBTTimepoint: 1 year

Secondary

MeasureTime frame
Persistent disease/residual tumors and recurrences and complicationsTimepoint: 1 year

Countries

India

Contacts

Public ContactShritosh Kumar

AIIMS, New Delhi

nayyarrishi202@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026