Skip to content

A clinical trial to study the effects of performing and omitting a restage transurethral resection of bladder tumour in patients with non-muscle invasive bladder tumours.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078306
Enrollment
84
Registered
2024-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: C67- Malignant neoplasm of bladder Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Omission of restage TURBT: The process of randomization will begin once histopathology report of the primary TUR is obtained. No re-TUR arm: 1. Patients with TaHG/T1LG histopathologie

Sponsors

AIIMS, NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Primary presentation bladder cancer without any prior resection or intravesical treatment Patients with HPE report of LG, T1 or HG, Ta with presence of detrusor muscle in the specimen Tumour size less than 3cm Tumours less than 3 in number Patients with HPE report of HG T1 with a single tumour less than 3cm in size operated by faculty with presence of detrusor muscle in the specimen Aged more than 18 years Written informed consent

Exclusion criteria

Exclusion criteria: Patients who have undergone TURBT for bladder cancer with a postop HPE report of HG T2 Patients with history of previous TURBT CIS Tumour size more than 3cm Multiple tumours more than 3 in number Patients with a postop HPE report of HGT1 with tumour size more than 3cm or more than 1 tumour Absence of detrusor muscle in the specimen Incomplete resection of tumour Variant histology Patients who do not give informed consent. Perforation during initial TURBT American Society of Anesthesiologists Score more than 3

Design outcomes

Primary

MeasureTime frame
Incidence of recurrence in patients who undergo reTUR vs those who do not undergo reTUR Incidence of progression in patients who undergo reTUR vs those who do not undergo reTUR Tumor upstaging in patients who undergo a reTUR. Timepoint: Followup at 3 months, 6 months, 9 months and 1 year after surgery

Secondary

MeasureTime frame
Time to recurrence & progression between the two groups Time to delay in definitive treatment in patients who undergo a reTUR Timepoint: Followup of 3 months, 6 months, 9 months & 1 year after surgery

Countries

India

Contacts

Public ContactMOUNIKA BALABOLU

All India Institute of Medical Sciences , New Delhi

brusabhanu@gmail.com9868449607

Outcome results

None listed

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