Bladder CancerBUCEAHNCT04683536
Bakircay University Cigli Training and Research Hospital
An observational study of Bladder Cancer, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Obturator nerve blockade
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with lateral wall localized non muscle invasive bladder cancer underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade
Who may be able to join
- patients with lateral wall localized non muscle invasive bladder cancer
Who cannot join
- history of previous TUR-BT
- diagnosis of non-urothelial carcinoma
- coagulopathy
- history of allergic reaction to the local anesthtetic agent
- presence of muscle-invasive bladder cancer
- history of chemotherapy or radiotherapy before TUR-BT
Show all 12Show fewer
- precence of variant histopathology
- using bipolar energy for the resection of bladder tumor
- presence of concomittant upper urothelial tract urothelial carcinoma
- patients with the neuromusculer disease
- pregnancy
- history of medication effecting immune system
About this study
The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer
Read the detailed description
Patient divided into two group.First group includes patients underwent TUR-BT under only spinal anesthesia and second group includes patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade.
- Conditions
- Bladder Cancer
- Being tested
- Obturator nerve blockade
- Keywords
- obturator nerve blockade, bladder cancer, non-muscle invasive bladder cancer, adductor contraction, bladder perforation
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator nerve blockadeProcedure or surgery
We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer
| Study group | Role | What they receive |
|---|---|---|
| control group | Patients underwent TUR-BT under spinal anesthesia Receives: Procedure: Obturator nerve blockade | |
| Study group | Patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade Receives: Procedure: Obturator nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological outcomes
Reccurens or progression of tumor was recorded
Measured: 5 year
Secondary outcomes (1)
Complications
Complications during surgery was recorded
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study startJan 2015
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683536
- Sponsor's protocol ID
- Cigli
- Acronym
- BUCEAH
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bakircay University Cigli Training and Research Hospital
- ClinicalTrials.gov ID
- NCT04683536
- Acronym / sponsor ID
- BUCEAH / Cigli
- Conditions
- Bladder Cancer
- Keywords
- obturator nerve blockade, bladder cancer, non-muscle invasive bladder cancer, adductor contraction, bladder perforation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 24 Dec 2020 (actual)
- 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.
The aim of the study is to investigate the oncological outcomes of obturator nerve blockade in patients with lateral wall localized non-muscle invasive bladder cancer
Detailed description
Patient divided into two group.First group includes patients underwent TUR-BT under only spinal anesthesia and second group includes patients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Procedure: Obturator nerve blockadePatients underwent TUR-BT under spinal anesthesia |
| Study group | – | Procedure: Obturator nerve blockadePatients underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with lateral wall localized non muscle invasive bladder cancer underwent TUR-BT under spinal anesthesia combined with ultrasound guided obturator nerve blockade
Key inclusion criteria (1 listed)
- patients with lateral wall localized non muscle invasive bladder cancer
Key exclusion criteria (12 listed)
- history of previous TUR-BT
- diagnosis of non-urothelial carcinoma
- coagulopathy
- history of allergic reaction to the local anesthtetic agent
- presence of muscle-invasive bladder cancer
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 |
|---|---|---|
| Obturator nerve blockadeWe performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer | Procedure or surgery | Study group, control group |
Primary outcome
Oncological outcomes
Time frame: 5 year
Reccurens or progression of tumor was recorded
1 secondary outcome
Complications
Time frame: 5 years
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 24 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Recep Tayyip Erdogan University Training and Research Hospital.
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 1 inclusion and 12 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Oncological outcomes (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2020.