Urinary Bladder TraumaNCT06147804
Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations
A study testing Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation in people with Urinary Bladder Trauma, run by Assiut University.
Trial summary
We aimed to evaluate the management and outcome of bladder trauma after gynecological and obstetric operations at Assiut university hospital and to evaluate the methods of treatment of these complications. We aimed to find out risk factors for vesico uterine fistula after bladder trauma Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder Trauma
- What is being tested?
- Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Interventional
- 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -
- All patients with Urinary bladder injuries related to Obst/Gyn operations
Who cannot join
- no exclusion criteria in all patients with bladder trauma after gyn \&obs operations
Trial locations and contacts
No sites are listed yet.
About this study
We aimed to evaluate the management and outcome of bladder trauma after gynecological and obstetric operations at Assiut university hospital and to evaluate the methods of treatment of these complications.
We aimed to find out risk factors for vesico uterine fistula after bladder trauma
Read the detailed description
The female genital and urinary systems are closely related embryologically and anatomically. The surgeon should know the anatomy of this area to avoid urinary tract (UT) injuries during obstetric (Obst) and gynecologic (Gyn) surgeries (Solyman et al., 2022)
UT injuries during Obst/Gyn surgeries are rare but have a significant psychological impact on both patient and surgeon, and their medico legal aspects are very bothering (Safrai et al., 2022)
UT injuries during Obst/Gyn operations range from 0.3 to 1% (Blackwell et al., 2018) Most cases are bladder injury, approximately three times more than ureteral injury (Wong et al., 2018)
The primary goal of the Obst/Gyn surgeon is to avoid UT injuries during his procedure. Still, in some situations, this will be difficult as in patients with abnormal anatomy, difficult operations as in the presence of severe bleeding or pelvic adhesions, and with surgeons with low experience. Immediate intraoperative repair of these injuries is optimal. In some cases, diagnosis and management are delayed postoperatively(Patel and Heisler, 2021)
UT injuries during Obst/Gyn operations are either acute injuries such as bladder and ureteral laceration, and ureteral ligation identified immediately intra operatively or chronic injuries as fistula formation and stricture ureter, which are discovered later on (Lee et al., 2012) Iatrogenic urological complications from gynecological surgery can be prevented and reduced by complying with standard surgical
- Conditions
- Urinary Bladder Trauma
- Being tested
- Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation
- Keywords
- Urinary bladder trauma after gynaecological and obstetric operations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical managment of Urinary bladder trauma after gynaecological and obstetric operationProcedure or surgery
How to manage Urinary bladder trauma after gynaecological and obstetric operations by the best method to prevent the occurrnce of vesicouterine fistula
| Study group | Role | What they receive |
|---|---|---|
| Females after gynaecological and obstetric operations | Experimental | Comaprison of the outcome Receives: Procedure: Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the surgical managment of the bladder tear
By the occurrence of vesicogenital fistula or not
evaluate the prevalence of vesicogenital fistula after bladder trauma after gynaecological and obstetric operations
Measured: Follow up after 3 weeks and 3 months and 6 months
Secondary outcomes (1)
To evaluate the quality of life, satisfaction of patients, UTI manifestations
By directly questioning the patient
Measured: After 3 weeks and 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder TraumaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ashraf Abdelmageed Hamdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147804
- Sponsor's protocol ID
- UB trauma after gyn&obs op
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations
- ClinicalTrials.gov ID
- NCT06147804
- Acronym / sponsor ID
- UB trauma after gyn&obs op
- Conditions
- Urinary Bladder Trauma
- Keywords
- Urinary bladder trauma after gynaecological and obstetric operations
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 28 Nov 2023 (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.
We aimed to evaluate the management and outcome of bladder trauma after gynecological and obstetric operations at Assiut university hospital and to evaluate the methods of treatment of these complications.
We aimed to find out risk factors for vesico uterine fistula after bladder trauma
Detailed description
The female genital and urinary systems are closely related embryologically and anatomically. The surgeon should know the anatomy of this area to avoid urinary tract (UT) injuries during obstetric (Obst) and gynecologic (Gyn) surgeries (Solyman et al., 2022)
UT injuries during Obst/Gyn surgeries are rare but have a significant psychological impact on both patient and surgeon, and their medico legal aspects are very bothering (Safrai et al., 2022)
UT injuries during Obst/Gyn operations range from 0.3 to 1% (Blackwell et al., 2018) Most cases are bladder injury, approximately three times more than ureteral injury (Wong et al., 2018)
The primary goal of the Obst/Gyn surgeon is to avoid UT injuries during his procedure. Still, in some situations, this will be difficult as in patients with abnormal anatomy, difficult operations as in the presence of severe bleeding or pelvic adhesions, and with surgeons with low experience. Immediate intraoperative repair of these injuries is optimal. In some cases, diagnosis and management are delayed postoperatively(Patel and Heisler, 2021)
UT injuries during Obst/Gyn operations are either acute injuries such as bladder and ureteral laceration, and ureteral ligation identified immediately intra operatively or chronic injuries as fistula formation and stricture ureter, which are discovered later on (Lee et al., 2012) Iatrogenic urological complications from gynecological surgery can be prevented and reduced by complying with standard surgical
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females after gynaecological and obstetric operations | Experimental | Procedure: Surgical managment of Urinary bladder trauma after gynaecological and obstetric operationComaprison of the outcome |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- -
- All patients with Urinary bladder injuries related to Obst/Gyn operations
Key exclusion criteria (1 listed)
- no exclusion criteria in all patients with bladder trauma after gyn \&obs operations
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 |
|---|---|---|
| Surgical managment of Urinary bladder trauma after gynaecological and obstetric operationHow to manage Urinary bladder trauma after gynaecological and obstetric operations by the best method to prevent the occurrnce of vesicouterine fistula | Procedure or surgery | Females after gynaecological and obstetric operations |
Primary outcome
To measure the surgical managment of the bladder tear
Time frame: Follow up after 3 weeks and 3 months and 6 months
By the occurrence of vesicogenital fistula or not evaluate the prevalence of vesicogenital fistula after bladder trauma after gynaecological and obstetric operations
1 secondary outcome
To evaluate the quality of life, satisfaction of patients, UTI manifestations
Time frame: After 3 weeks and 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation in people with Urinary Bladder Trauma, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Hamdallah (01009702496, Mohamed.15235465@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the surgical managment of the bladder tear (time frame: Follow up after 3 weeks and 3 months and 6 months). 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 28 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.