Urological Injuries During Obstetric and Gynecological Operations

November 12, 2019 updated by: Ahmed Kamal Kamel, Assiut University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergo obstetric or gynecological surgery complicated by urinary tract injury .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 12, 2019

First Submitted That Met QC Criteria

November 12, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • urological injuries

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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