Complications of Transurethral Resection of the Bladder Tumour

An observational study of Bladder Cancer, run by Medical University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bladder Cancer
What is being tested?: Transurethral resection of the bladder tumour
Type of treatment: Surgery or procedure
How many people: 983 participants
Where: 1 sitePoland
Study dates: Dec 2016to Nov 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All adult patients undergoing TURBT

Who may be able to join

primary or recurrent bladder tumour
informed consent to undergo the surgery

Who cannot join

age <18 years

Trial locations and contacts

1 site in 1 country.

Poland1 site

Medical University of Warsaw, Dept. of Urology
Warsaw, 02005

Other trials in Poland

About this study

Official title: Complications of Transurethral Resection of the Bladder Tumour: A Prospective Analysis of Incidence and Predictive Factors

Conditions: Bladder Cancer
Being tested: Transurethral resection of the bladder tumour
Keywords: bladder cancer, postoperative complications
Medical subject headings: Urinary Bladder Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transurethral resection of the bladder tumourProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Complications rate
Measured: 30 days postop

Secondary outcomes (1)

Complications severity
Severity of surgical complications according to Clavien-Dindo classification
Measured: 30 days postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2016Nov 2017

First posted24 Jan 2017 (estimated)
Study startDec 2016
Primary completionSep 2017
Study completionNov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bladder CancerStudies of the same condition, open and under way.
More trials run by Medical University of WarsawThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 983 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03029663
Sponsor's protocol ID: 12/2016
Acronym: ComTUR
Status last verified: Jan 2017
First submitted: 27 Dec 2016
Last updated: 28 Dec 2018
Results posted: No

Publications

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.
PubMed 32542089

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

All Bladder Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complications of Transurethral Resection of the Bladder Tumour: A Prospective Analysis of Incidence and Predictive Factors
ClinicalTrials.gov ID: NCT03029663
Acronym / sponsor ID: ComTUR / 12/2016
Conditions: Bladder Cancer
Keywords: bladder cancer, postoperative complications
Study type: Observational
Recruitment status: Completed
Enrolment: 983 participants (actual)
Lead sponsor: Medical University of WarsawUniversity, hospital or other
Study start: Dec 2016
Primary completion: Sep 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 24 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All adult patients undergoing TURBT

Key inclusion criteria (2 listed)

primary or recurrent bladder tumour
informed consent to undergo the surgery

Key exclusion criteria (1 listed)

age <18 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transurethral resection of the bladder tumour	Procedure or surgery	–

Primary outcome

Complications rate
Time frame: 30 days postop

1 secondary outcome

Complications severity
Time frame: 30 days postop

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
Derived from this study: PubMed 32542089Poletajew 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.

Related trials for Bladder Cancer

RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Bladder Cancer, run by Medical University of Warsaw at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complications rate (time frame: 30 days postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03029663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.