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

NCT04768894 | Completed

• 1 other identifier: SBUATRH
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

Brief 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

Bladder Cancer

Keywords

Bladder cancer; Restaging transurethral resection

Outcome Measures

Primary Outcomes (1)

• Recurrence free survival

  Recurrence free survival

  at least 1 year

Study Arms (3)

14-28 days

ACTIVE COMPARATOR

In group 1,the time interval between initial and re-TUR was 14-28 days,

Procedure: Second transurehral resection of bladder tumour

29-42 days

ACTIVE COMPARATOR

In group 2, the time interval between initial and re-TUR was 29-42 days

Procedure: Second transurehral resection of bladder tumour

43-56 days

ACTIVE COMPARATOR

In group 3, the time interval between initial and re-TUR was 43-56 days

Procedure: Second transurehral resection of bladder tumour

Interventions

Second transurehral resection of bladder tumour PROCEDURE

Remove of the bladder tumour as endoscopically

14-28 days; 29-42 days; 43-56 days

Eligibility Criteria

• Age: 44 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a tumor pathology other than transitional cell carcinoma, incomplete resection at initial TUR, who cannot complete 1 year of maintenance BCG treatment, did not attend their regular cystoscopic control or wanted to leave from the study voluntarily and lastly, with a diagnosis of muscle-invasive cancer on re-TUR were excluded.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Urology

Model Details: This is a clinical study. Patients with high grade non-muscle invasive bladder canser divided three groups according to time lapse.

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: February 24, 2021
• Study Start: August 1, 2016
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share