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Impact of Time to Re-staging Transurethral Resection on Recurrence and Progression Rates

NCT04768894 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2021-02-26

No results posted yet for this study

Summary

Purpose To investigate the significance of time to re-staging transurethral resection (re-TUR) on recurrence and progression rates in patient with high-risk non-muscle-invasive bladder cancer.

Methods Patients diagnosed with primary high risk non-muscle-invasive bladder cancer were included to the study. The patients were randomly seperated into 3 groups acoording to Re-TUR timing. In group 1,2, and 3, the time interval between initial and re-TUR were 14-28 days, 29-42 days, and 43-56 days respectively. Kaplan -meier plots were used to estimate differences in recurrence free survival (RFS) and progression free survival (PFS) rates. Cox regression analysis was used to assess the effect of time from initial TUR to re-TUR on oncological outcomes.

Results A total of 109 patients with high risk non-muscle-invasive bladder cancer were randomly divided into 3 groups. Twenty patients in group 1 (14-28 days), 22 patients in group 2 (29-42 days), and 29 patients in group 3 (43-56 days) completed the study. The mean follow-up was 20 ± 8.9 months. Kaplan-Meier plots showed no differences in RFS and PFS rates between the three groups. Cox regression analysis demonstrated that only tumor number was found to be a prognostic factor on RFS rates.

Conclusion Our prospective study demonstrated that time laps from initial TUR to re-TUR did not significantly affect on RFS and PFS rates.

Conditions

Interventions

PROCEDURE

Second transurehral resection of bladder tumour

Remove of the bladder tumour as endoscopically

Sponsors & Collaborators

  • Saglik Bilimleri Universitesi

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
44 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2020-12-10
Completion
2020-12-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768894 on ClinicalTrials.gov