Urologic InjuriesNCT04162782
Urological Injuries During Obstetric and Gynecological Operations
An observational study of Urologic Injuries, run by Assiut University.
Trial summary
Iatrogenic urinary tract injuries are more common during obstetric and gynaecological procedures averaging 2.6 per 1000 surgeries . The objective of the study is to estimate the incidence of iatrogenic urinary tract injuries and risk factors during obstetric and gynaecological operations. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Urologic Injuries
- What is being tested?
- obstetric and gynaecological surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 1 Dec 2021
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women undergo obstetric or gynecological surgery complicated by urinary tract injury .
Who may be able to join
- Women that undergo obstetric or gynecological surgery complicated by urinary tract injury
- Aged 15 years or older
- Elective surgeries
- Good performance status
Who cannot join
- Not meeting all of the inclusion criteria
About this study
Official title: Cross Sectional Study of Iatrogenic Urinary Tract Injuries During Obstetric and Gynecological Operations in Assiut University Women Health Hospital
Iatrogenic urinary tract injuries are more common during obstetric and gynaecological procedures averaging 2.6 per 1000 surgeries . The objective of the study is to estimate the incidence of iatrogenic urinary tract injuries and risk factors during obstetric and gynaecological operations.
Embryologically, the urinary system and genital system have a common origin, so anatomically they are so close that predisposes to iatrogenic trauma to it during obstetric and gynaecological operations. The bladder and distal ureters are the most commonly involved organs. The bladder is a retroperitoneal structure, its trigone rests over the anterior vaginal fornix and the base rests on lower uterine segment and cervix.
Read the detailed description
Risk factors may contribute to intra-operative bladder injury - include :
- Prolonged labour with distended bladder.
- Obstructed labour.
- Previous cesarean section.
- previous myomectomy.
- previous laparotomy.
- Cases with possibility of altered anatomy, fibrosis or direct extension of disease process as in cases of chronic pelvic inflammatory disease, endometriosis, and large fibroids especially in the broad ligament, previous pelvic surgery, malignancy, previous irradiation and congenital abnormalities of urogenital system.
- Past history of uterine perforation, septic abortion.
- In presence of labour, station of the presenting fetal part deeper than or equal to +1, and a large baby were independent risks for a bladder injury during caesarean section.
- Well effacement and dilatation of cervix (uterine incision may fall over vagina and dissection of bladder from vagina is difficult in compare to lower uterine segment).
- Preterm cesarean section where lower segment is not well formed.
- During cesarean hysterectomy.
- Rupture uterus may also be combined with bladder injuries.
- Placenta percreta may penetrate the bladder and cause injury.
Urinary tract injury can be diagnosed intraoperative :
- presence of urine in the operative field.
- Hematuria
- Methylene Blue test
- Conditions
- Urologic Injuries
- Being tested
- obstetric and gynaecological surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obstetric and gynaecological surgeriesProcedure or surgery
surgeries for gynecologic and obstetric diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations.
frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
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 Urologic InjuriesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Kamal Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162782
- Sponsor's protocol ID
- urological injuries
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tarney CM. Bladder Injury During Cesarean Delivery. Curr Womens Health Rev. 2013 May;9(2):70-76. doi: 10.2174/157340480902140102151729.
PubMed 24876830
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross Sectional Study of Iatrogenic Urinary Tract Injuries During Obstetric and Gynecological Operations in Assiut University Women Health Hospital
- ClinicalTrials.gov ID
- NCT04162782
- Acronym / sponsor ID
- urological injuries
- Conditions
- Urologic Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 14 Nov 2019 (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.
Iatrogenic urinary tract injuries are more common during obstetric and gynaecological procedures averaging 2.6 per 1000 surgeries . The objective of the study is to estimate the incidence of iatrogenic urinary tract injuries and risk factors during obstetric and gynaecological operations.
Embryologically, the urinary system and genital system have a common origin, so anatomically they are so close that predisposes to iatrogenic trauma to it during obstetric and gynaecological operations. The bladder and distal ureters are the most commonly involved organs. The bladder is a retroperitoneal structure, its trigone rests over the anterior vaginal fornix and the base rests on lower uterine segment and cervix.
Detailed description
Risk factors may contribute to intra-operative bladder injury - include :
- Prolonged labour with distended bladder.
- Obstructed labour.
- Previous cesarean section.
- previous myomectomy.
- previous laparotomy.
- Cases with possibility of altered anatomy, fibrosis or direct extension of disease process as in cases of chronic pelvic inflammatory disease, endometriosis, and large fibroids especially in the broad ligament, previous pelvic surgery, malignancy, previous irradiation and congenital abnormalities of urogenital system.
- Past history of uterine perforation, septic abortion.
- In presence of labour, station of the presenting fetal part deeper than or equal to +1, and a large baby were independent risks for a bladder injury during caesarean section.
- Well effacement and dilatation of cervix (uterine incision may fall over vagina and dissection of bladder from vagina is difficult in compare to lower uterine segment).
- Preterm cesarean section where lower segment is not well formed.
- During cesarean hysterectomy.
- Rupture uterus may also be combined with bladder injuries.
- Placenta percreta may penetrate the bladder and cause injury.
Urinary tract injury can be diagnosed intraoperative :
- presence of urine in the operative field.
- Hematuria
- Methylene Blue test
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergo obstetric or gynecological surgery complicated by urinary tract injury .
Key inclusion criteria (4 listed)
- Women that undergo obstetric or gynecological surgery complicated by urinary tract injury
- Aged 15 years or older
- Elective surgeries
- Good performance status
Key exclusion criteria (1 listed)
- Not meeting all of the inclusion criteria
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 |
|---|---|---|
| obstetric and gynaecological surgeriessurgeries for gynecologic and obstetric diseases | Procedure or surgery | – |
Primary outcome
frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations.
Time frame: one month
frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Background: PubMed 24876830Tarney CM. Bladder Injury During Cesarean Delivery. Curr Womens Health Rev. 2013 May;9(2):70-76. doi: 10.2174/157340480902140102151729.
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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 Urologic Injuries, 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 4 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 14 Nov 2019. 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?
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?
frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations. (time frame: one month). 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 NCT04162782, 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 14 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.