跳至主要内容
临床试验/NCT01183000
NCT01183000已完成不适用

Effects of Closure Versus Non-closure of the Visceral and Parietal Peritoneum at Cesarean Section on Adhesions: A Prospective Randomized Study

Barzilai Medical Center3 个研究点 分布在 1 个国家目标入组 533 人开始时间: 2010年1月16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
533
试验地点
3
主要终点
Adhesion score

研究概览

简要总结

Objective: To determine the effect of non-closure of the visceral and parietal peritoneum during Cesarean section on the formation of adhesions.

Study design: A prospective randomized trial of 533 women undergoing primary Cesarean section; 256 were randomized to non closure and 277 to closure of the peritoneum. At a subsequent cesarean,he presence of adhesions and their severity was evaluated at several sites: between the layers of the abdominal wall, between the bladder and the abdominal wall, between bladder and uterus, between the uterus and the abdominal wall, and between the bowels and the pelvic organs. A cumulative adhesion score was calculated.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing primary CS

排除标准

  • Lack of consent by the patient or an urgent cesarean not allowing time to elicit an informed consent
  • Previous pelvic or abdominal surgery

研究组 & 干预措施

peritoneal closure

Active Comparator

干预措施: Closure of the peritoneum at cs (Procedure)

Non closure of the peritoneum

No Intervention

结局指标

主要结局

Adhesion score

时间窗: 6 years

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

ofer gemer

Prof. Ofer Gemer

Barzilai Medical Center

研究点 (3)

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