NCT04768894

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

Completed NA Last updated 26 February 2021

What this trial tests

NA trial testing Second transurehral resection of bladder tumour in Bladder Cancer in 109 participants. Completed in 10 December 2020.

Timeline

1 August 2016

Primary endpoint
10 December 2020

10 December 2020

Quick facts

Lead sponsor	Saglik Bilimleri Universitesi
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	109
Start date	1 August 2016
Primary completion	10 December 2020
Estimated completion	10 December 2020

Drugs / interventions tested

• Second transurehral resection of bladder tumour

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Saglik Bilimleri Universitesi — full company profile →

Who can join

Adults 44 to 86, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.