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临床试验/NCT02977871
NCT02977871已完成不适用

A Randomized Trial Comparing Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
201
试验地点
1
主要终点
Total operation time

研究概览

简要总结

Cesarean section is the most common surgical procedure performed on women. Over the years minor variations of each surgical step have been introduced, and cesarean sections are not standardized and many different techniques are employed during surgery. Creation of a bladder flap has been an integral surgical step of the cesarean section for many years. The role of the bladder flap and its usefulness in cesarean section is not known well. Further, in some cases the bladder flap is omitted during cesarean section. The aim of the current study is to compare operating time and postoperative urinary symptoms in cesarean sections using either bladder flap or omission of flap.

详细描述

Cesarean section is the most common surgical procedure performed on women. The main aspects of the surgical approach to low-transverse cesarean delivery have not changed much since1926. Over the years minor variations of each surgical step have been introduced, and cesarean sections are not standardized and many different techniques are employed during surgery. Creation of a bladder flap has been an integral surgical step of the cesarean section for many years. The evidence on the role of the bladder flap and its usefulness in cesarean section is very limited. In emergent cesarean sections where rapid delivery is the main goal, the bladder flap is usually omitted. Literature about the usefulness of a bladder flap is limited and more randomized studies are needed. Most of the study outcomes were focusing operating time however, the investigator in the current study additional focused on postoperative urinary symptoms and dynamics. The aim of the current study is to compare operating time and postoperative urinary symptoms in cesarean sections using either bladder flap or omission of flap.

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •primiparous women >37 weeks without high-risk pregnancy

排除标准

  • •presence of microbiologically confirmed urinary tract infection before delivery, twin pregnancies, cervical dilatation at admission ≥4 cm, estimated fetal weight>4000 gr, history of previous abdominal surgery

研究组 & 干预措施

No Bladder Flap group

No Intervention

Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum.

Bladder Flap group

Active Comparator

Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.

干预措施: Bladder flap (Procedure)

结局指标

主要结局

Total operation time

时间窗: 1 hour

Total operation time from skin incision to the end of operation

次要结局

  • Bladder injury(up to 48 hour)
  • Urinary retention(up to 48 hour)
  • Estimated blood loss(1 hour)

研究者

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

Berna Aslan Cetin

Attending Physician, ObGyn

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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