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临床试验/NCT07050082
NCT07050082已完成不适用

Cystoinflation to Prevent Bladder Injury in Cases of Placenta Accreta Spectrum , a Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Incidence of bladder injury in two groups

研究概览

简要总结

Placenta accreta spectrum (PAS) disorders are associated with a high risk of bladder injury .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 in cases of 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. Data were analyzed using appropriate statistical tests with significance set at p<0.05.

详细描述

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 . PAS encompasses a spectrum of abnormal placental adherence, which can lead to life-threatening hemorrhage during delivery.

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.

Surgical management recognized as the standard of care for invasive placentation .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% .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 .

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 . 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% . Although injuries to the bowel, pelvic vasculature, and nerves are less common, they remain clinically significant .

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 .While routine preoperative bladder catheterization aids in visualizing the surgical field, it often fails to prevent bladder injury in cases with dense adhesions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Gestational age 34 weeks or more
  • BMI 18.5-29.9
  • Placcenta accreta diagnosed by ultrasound
  • Previous caesarian section
  • General anaesthetia

排除标准

  • medical disorders
  • History of bladder injury or previous bladder surgery

结局指标

主要结局

Incidence of bladder injury in two groups

时间窗: 18 months

Comparing incidence of bladder injury in cases of PAS with and without bladder filling

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Islam Sharawy Abdelrahman

Assistant lecturer

Cairo University

研究点 (1)

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