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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Bladder Trauma
• Intervention / Treatment: Procedure: Surgical managment of Urinary bladder trauma after gynaecological and obstetric operation

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Hamdallah; Phone Number: 01009702496; Email: Mohamed.15235465@med.aun.edu.eg
• Study Contact Backup: Name: Mahmoud Farok; Phone Number: +20 100 915 2070; Email: Mahmodfarok11@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Follow up after 3 weeks and 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the quality of life, satisfaction of patients, UTI manifestations	By directly questioning the patient	After 3 weeks and 3 months and 6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 18, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 18, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Urinary bladder trauma after gynaecological and obstetric operations
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: UB trauma after gyn&obs op

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No