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

Loop Resection or Cold-cup Biopsy? A Prospective Randomized Study Evaluating the Accuracy of Detrusor Muscle Representation During Transurethral Resection of Bladder Tumors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06796413

Enrollment

120

Registered

2025-01-28

Start date

2022-07-14

Completion date

2024-07-01

Last updated

2025-01-28

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

Conditions

Bladder Cancer, Bladder Cancer Stage I, TURBT

Keywords

Bladder Cancer, Detrusor Muscle Sampling, Detrusor Muscle Representation, Loop Resection, Cold-Cup Biopsy, Artifacts

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.

Interventions

PROCEDURELoop 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026