Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06147804
Collaborator
(none)
40
1
12

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Managment and Outcome of Urinary Bladder Trauma After Gynaecological and Obstetric Operations
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Females after gynaecological and obstetric operations

Comaprison of the outcome

Procedure: Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation
How to manage Urinary bladder trauma after gynaecological and obstetric operations by the best method to prevent the occurrnce of vesicouterine fistula

Outcome Measures

Primary Outcome Measures

  1. To measure the surgical managment of the bladder tear [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

Secondary Outcome Measures

  1. To evaluate the quality of life, satisfaction of patients, UTI manifestations [After 3 weeks and 3 months and 6 months]

    By directly questioning the patient

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

All patients with Urinary bladder injuries related to Obst/Gyn operations

Exclusion Criteria:
  • no exclusion criteria in all patients with bladder trauma after gyn &obs operations

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Ashraf Abdelmageed Hamdallah, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT06147804
Other Study ID Numbers:
  • UB trauma after gyn&obs op
First Posted:
Nov 28, 2023
Last Update Posted:
Nov 28, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Ashraf Abdelmageed Hamdallah, Resident, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 28, 2023