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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04162782
Other study ID # urological injuries
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date December 1, 2021

Study information

Verified date November 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


Description:

Risk factors may contribute to intra-operative bladder injury - include :

1. Prolonged labour with distended bladder.

2. Obstructed labour.

3. Previous cesarean section.

4. previous myomectomy.

5. previous laparotomy.

6. 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.

7. Past history of uterine perforation, septic abortion.

8. 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.

9. 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).

10. Preterm cesarean section where lower segment is not well formed.

11. During cesarean hysterectomy.

12. Rupture uterus may also be combined with bladder injuries.

13. Placenta percreta may penetrate the bladder and cause injury.

Urinary tract injury can be diagnosed intraoperative :

1. presence of urine in the operative field.

2. Hematuria

3. Methylene Blue test


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Women that undergo obstetric or gynecological surgery complicated by urinary tract injury

- Aged 15 years or older

- Elective surgeries

- Good performance status

Exclusion Criteria:

- Not meeting all of the inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
obstetric and gynaecological surgeries
surgeries for gynecologic and obstetric diseases

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Tarney CM. Bladder Injury During Cesarean Delivery. Curr Womens Health Rev. 2013 May;9(2):70-76. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations. frequency of iatrogenic urinary tract injuries during obstetric and gynaecological operations. one month
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