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

NCT ID: NCT06796413

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2024-07-01

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.

Conditions

Bladder Cancer; Bladder Cancer Stage I; TURBT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Cold-Cup Biopsy

Cold-Cup Biopsy of bladder tumor base

Group Type: ACTIVE_COMPARATOR

Loop Resection or Cold-cup biopsy

Intervention Type: PROCEDURE

Loop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen

Loop Resection of bladder tumor base

Loop Resection of bladder tumor base

Group Type: EXPERIMENTAL

Loop Resection or Cold-cup biopsy

Intervention Type: PROCEDURE

Loop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen

Interventions

Loop Resection or Cold-cup biopsy

Loop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen

Intervention Type: PROCEDURE

Other Intervention Names

Loop Cautery; Cold-cup Biopsy

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Stellenbosch

OTHER

Sponsor Role: lead

Responsible Party

Dr Eduan Delport

Urology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduan Delport, MB, ChB

Role: PRINCIPAL_INVESTIGATOR

University of Stellenbosch

Locations

Stellenbosch University - Faculty of Health Sciences - Department of Urology

Cape Town, Western Cape, South Africa

Countries

South Africa

Other Identifiers

17234

Identifier Type: -

Identifier Source: org_study_id