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临床试验/NCT00918996
NCT00918996已完成不适用

The Bladder Flap at Cesarean Delivery: Establishing Evidence for Practice

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2010年3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
258
试验地点
1
主要终点
Total operating time (from skin incision to closure of the skin).

研究概览

简要总结

Cesarean section is now the most common major surgical procedure performed on women world wide. In the United States, approximately 1 in 4 deliveries is by this method. With the increasing numbers of cesarean sections, there is the need to utilized evidence based techniques to optimize outcomes and minimize complications.Creation of the bladder flap is an integral step of the standard cesarean section. The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment. Started in the pre-antibiotic era, the rationale for the bladder flap was to enable the surgeon gain access to the lower uterine segment while minimizing injury to the bladder. Its subsequent closure was supposed to protect the peritoneal cavity from intrauterine infection. Since then, closure of the bladder flap has been demonstrated to be unnecessary and has been abandoned. The bladder flap however, continues to be performed without evidence of benefit.

Evidence on the role of the bladder flap in cesarean section is very limited. In emergent cesarean sections where rapid delivery is the goal, the bladder flap is commonly omitted. A simplified method of cesarean section (Pelosi-type) including omission of the bladder among other modifications has been shown to be safe and cost saving. The single randomized trial on omission of the bladder flap as the only modification suggests short term benefits including shorter operating times, reduced blood loss and decreased postoperative analgesic requirements. This study has been criticized for evaluating only short term outcomes and including only primary cesarean sections. The paucity of evidence for or against this commonly utilized technique in cesarean section is the rationale for this study.

The goal of this study is to employ a well designed randomized controlled clinical trial to evaluate the effects of omitting the bladder flap creation at cesarean section. We hypothesize that omission of the bladder flap in both primary and repeat cesarean sections will be associated with shorter operating time without a significant increase in intraoperative and postoperative complications.

详细描述

BACKGROUND

Cesarean section is the most common major surgical procedure in women world wide. In the United States almost 25% of deliveries are by cesarean section and the rate continues to rise [1]. In performing this procedure, it is imperative that evidence based techniques are utilized to optimize outcomes and minimize complications. Recently, the case has been made for simplifying the procedure by eliminating unnecessary and potentially harmful steps [2].

Rationale for the Bladder Flap Challenged: While the creation of the bladder flap has long been an integral part of the standard cesarean section, there is no evidence of benefit. Creation of the bladder flap at cesarean section dates back to the pre-antibiotic era of the 19th century. One rationale was to enable the surgeon gain access to the lower uterine segment while minimizing injury to the bladder [3]. While some older case reports suggested inadequate bladder flap reflection as a risk factor for bladder injury, it has not been collaborated [4]. On the contrary, several studies have identified difficulty encountered while developing the bladder flap as a risk factor for bladder injury at cesarean section [5, 6]. Although uncommon, creation of the bladder flap may also be associated with complications such as bladder flap hematoma and dysuria, sometimes requiring re-operation to drain the collection or release the bladder flap [7-11]. It has also been suggested that disruption of the autonomic innervations by creation of the bladder flap results in an increased incidence of urinary retention. In the long term, creation of the bladder flap may result in thick adhesions in the lower uterine segment that may lead to difficult subsequent cesarean delivery and bladder perforation [3].

Another rationale for the creation and subsequent closure of the bladder flap was to protect the peritoneal cavity from intrauterine infection. With the use of antibiotics, closure of the bladder flap has been demonstrated to be unnecessary and associated with increased morbidity including febrile morbidity, adhesions and upward dislocation of the urinary bladder [12, 13]. This evidence resulted in abandonment of closure of the bladder flap at cesarean section. Yet its creation has remained part of standard practice.

Limited Data on Role of Bladder Flap: Data on the role of the bladder flap in cesarean section is very limited. A simplified method of cesarean section (Pelosi-type) involving omission of the bladder among other modifications has been shown to be safe and cost saving [2]. Only one published study evaluated omission of the bladder flap as the only modification [14]. This single randomized trial compared omission of the bladder flap in 53 patients to the standard technique of cesarean section in 49 patients. The results showed significant short term benefits of omitting the bladder flap including a reduction in operating time, blood loss, postoperative pain and microhematuria.

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 42 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients undergoing non-emergent primary and repeat cesarean sections at or greater than 32 weeks gestation at Barnes Jewish Hospital during the study period.

排除标准

  • •Emergent cesarean sections, planned vertical uterine incision, previous abdominal surgeries (besides prior cesarean sections), sedation and inability to obtain consent.

研究组 & 干预措施

No Bladder Flap Group

Experimental

Uterine incision made 1 cm above the vesico-uterine reflection without incision and dissection of the bladder peritoneum.

干预措施: Omission of Bladder Flap Creation (Procedure)

Bladder Flap Group

No Intervention

Standard cesarean section technique with incision and dissection of a bladder flap prior to uterine incision.

结局指标

主要结局

Total operating time (from skin incision to closure of the skin).

时间窗: Intraoperative

次要结局

  • Skin incision to delivery time, skin incision to fascial closure time, blood loss, hematuria, dysuria, urinary retention, febrile morbidity, use of analgesics, hospital days, wound infection, endomyometritis, neonatal outcomes, and readmissions.(On first postoperative day and at 2-4 week postoperative visit)

研究者

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

Methodius Tuuli, MD, MPH

Investigator

Washington University School of Medicine

研究点 (1)

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