Bladder InjuryNCT06278753
Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy
An observational study of Bladder Injury and Ureter Injury, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Bladder Injury, Ureter Injury, Surgical Injury
- What is being tested?
- carbon dioxide cystoscopy
- How many people
- 540 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 1 Apr 2024
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo laparoscopic hysterectomy for benign reasons in our hospital
Who may be able to join
- laparoscopic hysterectomy for benign reasons planned patients
- The operation will be performed in our hospital
- Reporting preoperative endometrial and cervical samplings as benign
- After discharge, control examinations will be carried out in our hospital.
Who cannot join
- Abdominal, robotic or vaginal hysterectomies
- malignant reporting of preoperative cervical and endometrial samplings
- Patients do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Training and Research Hospital
Izmir, Eurasia, 35090
About this study
Official title: Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy Used to Evaluate Lower Urinary Tract Damage After Laparoscopic Hysterectomy.
For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.
Read the detailed description
It was aimed to investigate whether routine cystoscopy with carbon dioxide is a safer and faster method for the evaluation of lower urinary tract injuries compared to standard saline cystoscopy. In addition, with this study, it will be studied whether bladder bleeding or intra-bladder masses can be evaluated more quickly and clearly.
- Being tested
- carbon dioxide cystoscopy
- Keywords
- laparoscopic hysterectomy, lower urinary tract injury, cystoscopy
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon dioxide cystoscopyDiagnostic test
Using carbon dioxide medium for filling bladder
| Study group | Role | What they receive |
|---|---|---|
| Standard cystoscopy | Standard cystoscopy arm | |
| carbon dioxide cystoscopy | carbon dioxide cystoscopy arm Receives: Diagnostic Test: carbon dioxide cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy.
Measured: one year
Secondary outcomes (1)
It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Jul 2021
- Primary completion1 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder InjuryStudies 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
- Prospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdurrahman Hamdi İnan, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278753
- Sponsor's protocol ID
- 2025/05/02
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data table will be shared with the researcher who requests it.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy Used to Evaluate Lower Urinary Tract Damage After Laparoscopic Hysterectomy.
- ClinicalTrials.gov ID
- NCT06278753
- Acronym / sponsor ID
- 2025/05/02
- Keywords
- laparoscopic hysterectomy, lower urinary tract injury, cystoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 26 Feb 2024 (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.
For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.
Detailed description
It was aimed to investigate whether routine cystoscopy with carbon dioxide is a safer and faster method for the evaluation of lower urinary tract injuries compared to standard saline cystoscopy. In addition, with this study, it will be studied whether bladder bleeding or intra-bladder masses can be evaluated more quickly and clearly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard cystoscopy | – | –Standard cystoscopy arm |
| carbon dioxide cystoscopy | – | Diagnostic Test: carbon dioxide cystoscopycarbon dioxide cystoscopy arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo laparoscopic hysterectomy for benign reasons in our hospital
Key inclusion criteria (4 listed)
- laparoscopic hysterectomy for benign reasons planned patients
- The operation will be performed in our hospital
- Reporting preoperative endometrial and cervical samplings as benign
- After discharge, control examinations will be carried out in our hospital.
Key exclusion criteria (3 listed)
- Abdominal, robotic or vaginal hysterectomies
- malignant reporting of preoperative cervical and endometrial samplings
- Patients do not want to participate in the study
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 |
|---|---|---|
| carbon dioxide cystoscopyUsing carbon dioxide medium for filling bladder | Diagnostic test | carbon dioxide cystoscopy |
Primary outcome
It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy.
Time frame: one year
1 secondary outcome
It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses.
Time frame: one year
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 12 Feb 2025.
- Individual participant dataSharing planned: Undecided. The data table will be shared with the researcher who requests it.
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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.
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 Injury and Ureter Injury, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 12 Feb 2025. 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 Turkey (Türkiye). 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?
It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy. (time frame: one 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 12 Feb 2025.