跳至主要内容
临床试验/NCT03129035
NCT03129035Unknown不适用

Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy : A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Number of participants needed blood transfusion

研究概览

简要总结

All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention

详细描述

All women with placenta accreta will be managed by upper segment cesarean section followed by cesarean hysterectomy without attempts of placental removal.

Women were randomized to either bilateral internal iliac artery ligation before hysterectomy and after fetal extraction or no additional intervention.

Midline incision in the all patients is preferred. The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin.

Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side.

研究设计

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

入排标准

年龄范围
20 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •women with suspected placenta accreta
  • •Scarred uterus
  • •Approving hysterectomy

排除标准

  • •Women needed conservative surgery
  • •women with coagulopathy or bleeding disorders

研究组 & 干预措施

internal iliac artery ligation

Active Comparator

women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy

干预措施: Cesarean hystrectomy (Procedure)

internal iliac artery ligation

Active Comparator

women undergo bilateral internal iliac artery ligation after fetal extraction and before proceeding in cesarean hysterectomy

干预措施: Internal iliac artery ligation (Procedure)

No internal iliac artery ligation

Active Comparator

Women undergo cesarean hysterectomy after fetal extraction

干预措施: Cesarean hystrectomy (Procedure)

结局指标

主要结局

Number of participants needed blood transfusion

时间窗: within 24 hours from surgery

number of cases in each group who needed blood transfusion whether intraoperative or within 24 hours postoperative

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

Ahmed Maged

Professor

Cairo University

研究点 (1)

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