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

Not Applicable

Completed

• Conditions: Bladder Cancer; Bladder Cancer Stage I; TURBT

• Registration Number: NCT06796413
• Lead Sponsor: University of Stellenbosch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Primary Completion: 2024-05-23
• Study Completion: 2024-07-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detrusor Muscle Representation	From enrollment to the end of treatment at 2-4 weeks when histology results are available	Histopathological confirmation of detrusor muscle representation in the Deep Muscle Specimen obtained by either the Loop Resection method or Cold-Cup Biopsy method

Trial Locations

Locations (1)

Stellenbosch University - Faculty of Health Sciences - Department of Urology; 🇿🇦 Cape Town, Western Cape, South Africa