Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum , a Randomized Controlled Trial
- Conditions
- Bladder InjuryAccreta, Placenta
- Registration Number
- NCT07050082
- Lead Sponsor
- Cairo University
- Brief Summary
Placenta accreta spectrum (PAS) disorders are associated with a high risk of bladder injury during cesarean hysterectomy, leading to increased morbidity. Cystoinflation, involving controlled retrograde bladder filling, has been proposed as a technique to improve intraoperative visualization and reduce bladder injuries.
Objective To evaluate the efficacy and safety of cystoinflation in preventing bladder injuries during cesarean hysterectomy for PAS.
Methods This randomized controlled trial included 84 women diagnosed with PAS, allocated equally into cystoinflation and control groups. The cystoinflation group underwent bladder filling with 200 mL saline to facilitate dissection, while the control group did not. Primary outcome measures included the incidence of bladder injury, operative time, and hospitalization duration. Data were analyzed using appropriate statistical tests with significance set at p\<0.05.
- Detailed Description
The global incidence of placenta accreta spectrum (PAS) disorders are rising in parallel with the increasing rates of cesarean delivery, posing significant challenges in obstetric practice due to its association with severe maternal morbidity and mortality \[1\]. PAS encompasses a spectrum of abnormal placental adherence, which can lead to life-threatening hemorrhage during delivery \[2\].
In response to the limitations of traditional terminology (placenta accreta, increta, percreta), the International Federation of Gynecology and Obstetrics introduced a standardized classification under the umbrella of PAS disorders, aiming to improve diagnostic clarity and clinical management \[3\].
Surgical management typically involves cesarean hysterectomy, recognized as the standard of care for invasive placentation \[4\]. However, this procedure carries a substantial risk, with severe maternal morbidity rates reaching 40-50%, primarily due to hemorrhage and injury to adjacent organs. In extreme cases, maternal mortality may reach up to 7% \[5\]. The complexity of the surgery is heightened by the high risk of adjacent organ injury, with an adjusted odds ratio of 8.2 for damage to nearby structures \[6\].
Among these complications, urinary tract injury is notably prevalent. Risk factors include the depth and lateral extension of placental invasion, the extent of intraoperative blood loss, and the number of prior cesarean sections \[7\]. Urinary tract trauma occurs in approximately 29% of PAS-related surgeries, with bladder lacerations accounting for 76%, ureteral injuries for 17%, and genitourinary fistulas for 5% \[8\]. Although injuries to the bowel, pelvic vasculature, and nerves are less common, they remain clinically significant \[9\].
Bladder injury, in particular, has profound implications, contributing to prolonged operative time, urinary tract infections, voiding dysfunction, and extended catheterization, all of which adversely affect a patient's physical and psychological well-being \[10\]. While routine preoperative bladder catheterization aids in visualizing the surgical field, it often fails to prevent bladder injury in cases with dense adhesions \[11\].
One technique proposed to enhance intraoperative identification of bladder injury is the use of methylene blue dye \[10\].
This study aims to assess the efficacy and safety of bladder filling with methylene blue during bladder dissection in women diagnosed with PAS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 84
- Gestational age 34 weeks or more BMI 18.5-29.9 Placcenta accreta diagnosed by ultrasound Previous caesarian section General anaesthetia
- medical disorders History of bladder injury or previous bladder surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of bladder injury in two groups 18 months Comparing incidence of bladder injury in cases of PAS with and without bladder filling
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Faculty of medicine Cairo university
🇪🇬Cairo, Egypt
Faculty of medicine Cairo university🇪🇬Cairo, Egypt