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临床试验/NCT00195949
NCT00195949已完成3 期

Laparoscopic Versus Open Pyloromyotomy for Infants With Idiopathic Hypertrophic Pyloric Stenosis

Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2003年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
Operative Time

研究概览

简要总结

Pyloric stenosis is a condition that develops in infants and that leads to an obstruction of the channel going out of the stomach. This study is being performed to determine if there is an advantage to the laparoscopic approach or the open approach for the surgical correction of the enlarged pylorus.

详细描述

Pyloromyotomy for pyloric stenosis has traditionally been performed via an open technique. With advancements in minimally invasive surgery in infants a laparoscopic approach has been developed. These two approaches have never been critically evaluated with regard to superiority of one technique over the other. This is a prospective randomized trial involving infants with pyloric stenosis. It will enroll 100 patients in each arm (statistical and power analysis was performed by Steve Simon, PhD). Parental consent will be obtained and the patients will be randomized to undergo open or laparoscopic pyloromyotomy. Patient age at diagnosis, electrolyte disturbances at diagnosis, ultrasound findings, operative approach, length of pyloromyotomy, operative times, time to tolerating full feeds, number of emesis episodes, length of hospitalization, operative charges, and hospital charges will be collected for comparison between the groups.

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
— 至 12 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All infants less than 12 weeks of age who have undergone surgical consultation and abdominal ultrasound confirming the diagnosis of pyloric stenosis and whose parents have given consent for inclusion in the study.

排除标准

  • All patients greater than 12 weeks of age, or without parental consent, or without pyloric stenosis will be excluded from the study.

结局指标

主要结局

Operative Time

次要结局

  • Time to full feeds
  • Length of hospitalization
  • Pain medication requirements
  • Emesis episodes
  • Complications

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other

研究点 (2)

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