Loop Resection or Cold-cup Biopsy? a Study Comparing the Accuracy of Muscle Samples During Bladder Tumor Surgery

Stellenbosch University (SU)

Status: Completed

Conditions: Bladder Cancer; Bladder Cancer Stage I; TURBT

Treatments: Procedure: Loop Resection or Cold-cup biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06796413

17234

Details and patient eligibility

About

In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. The investigators found that both sampling methods are equal effective with regards to muscle representation, regardless of surgeon experience. An important finding is that Loop Resection produced less tissue artefacts in the deep muscle specimen for the more experienced surgeons, while there was no difference for less experienced surgeons. The investigators thus conclude that - from a practical point of view - Loop Resection should be the deep muscle sampling method of choice.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• • All patients requiring cystoscopy plus loop resection of bladder tumor.

Exclusion criteria

• • Patients who underwent cystoscopy and no loop resection

  • Patients who underwent cystoscopy and only cold-cup biopsy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Cold-Cup Biopsy

Active Comparator group

Description:

Cold-Cup Biopsy of bladder tumor base

Treatment:

Procedure: Loop Resection or Cold-cup biopsy

Loop Resection of bladder tumor base

Experimental group

Description:

Loop Resection of bladder tumor base

Treatment:

Procedure: Loop Resection or Cold-cup biopsy