NCT03029663

Brief Summary

This is a prospective study enrolling consecutive patients who undergo transurethral resection of the bladder tumour (TURBT) aimed at determination of a safety of the procedure. Study end-points are incidence, severity and predictive factors of surgical complications. The study secondary aim is a validation of Clavien Dindo scoring system for reporting complication of TURBT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
983

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 28, 2018

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

December 27, 2016

Last Update Submit

December 27, 2018

Conditions

Bladder Cancer

Keywords

bladder cancerpostoperative complications

Outcome Measures

Primary Outcomes (1)

  • Complications rate

    30 days postop

Secondary Outcomes (1)

  • Complications severity

    30 days postop

Interventions

Transurethral resection of the bladder tumourPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients undergoing TURBT

You may qualify if:

  • primary or recurrent bladder tumour
  • informed consent to undergo the surgery

You may not qualify if:

  • age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Dept. of Urology

Warsaw, 02005, Poland

Location

Related Publications (1)

  • Poletajew S, Krajewski W, Gajewska D, Sondka-Migdalska J, Borowik M, Buraczynski P, Dziegala M, Lykowski M, Przudzik M, Tukiendorf A, Wozniak R, Bar K, Jablonowski Z, Roslan M, Slojewski M, Zdrojowy R, Radziszewski P, Dziobek K. Prediction of the risk of surgical complications in patients undergoing monopolar transurethral resection of bladder tumour - a prospective multicentre observational study. Arch Med Sci. 2019 Oct 7;16(4):863-870. doi: 10.5114/aoms.2019.88430. eCollection 2020.

    PMID: 32542089DERIVED

MeSH Terms

Conditions

Urinary Bladder NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 24, 2017

Study Start

December 1, 2016

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

December 28, 2018

Record last verified: 2017-01

Locations

PL(1)