Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- postoperative length of stay
研究概览
简要总结
The purpose of this study is to determine whether short- and long-term outcomes are different between open and laparoscopic Nissen fundoplication performed in children younger than 2 years of age.
详细描述
Nissen fundoplication is a commonly performed procedure in infants and children with gastroesophageal reflux and a variety of other medical conditions including respiratory compromise, severe neurologic impairment, failure to thrive and swallowing dysfunction. Randomized controlled trials in adults have shown that laparoscopic fundoplication is a safe procedure that results in lower morbidity, shorter hospital length of stay and similar 5-year recurrence rates when compared to an open procedure. The aim of this study is to compare laparoscopic and open Nissen fundoplication in children less than 2 years of age.
Children younger than 2 years of age presenting for Nissen fundoplication will be randomized to either a laparoscopic or an open procedure. Patients who have already undergone anti-reflux surgery or whose hospitalization is anticipated to be prolonged by an unrelated illness will be excluded. All procedures will be performed at a single institution by two surgeons who will perform both the open and laparoscopic procedures.
A total of 68 patients will be needed (34 in each group) to detect a 20% difference in length of stay at a significance level of p < 0.05 and power of 80%. Patients will be followed for up to 2 years postoperatively. Variables to be compared between the two groups will include age, gender, presence of neurologic impairment, presence and specification of any congenital abnormalities, total operative time, total dose of narcotic analgesia required, postoperative day on which the patient tolerated full feedings, postoperative and total lengths of stay as well as the occurrence of postoperative complications (including wound infection and the need for immediate reoperation). The primary outcomes analyzed will be length of stay and amount of narcotic analgesia required. Longer-term outcomes including persistent GERD, wrap failure and need for reoperation within 24 months of the initial procedure also will be determined.
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
- Single (Care Provider)
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical or radiographic diagnosis of gastroesophageal reflux
- •age less than 2 years (24 months) at the time of surgery
排除标准
- •prior fundoplication procedure
- •concomitant need for an intraabdominal procedure (except gastrostomy tube placement)
- •esophageal dysmotility
- •hospitalization expected to be prolonged due to a concurrent illness actively being treated (e.g. congenital heart disease requiring surgical repair during the same hospitalization)
研究组 & 干预措施
open nissen fundoplication
open repair through surgical midline incision
干预措施: Nissen fundoplication (Procedure)
laparoscopic nissen fundoplication
use of laparoscope to do repair
干预措施: Nissen fundoplication (Procedure)
结局指标
主要结局
postoperative length of stay
时间窗: 0 to 14days
days in hospital
length of time to tolerating full feeds prior to discharge
时间窗: 0 to 7 days
days after surgery before feeding begins
postoperative narcotic pain medication requirements
时间窗: 0 to 14 days
days requiring narcotics for pain relief
次要结局
- death(up to 2 years)
- need for continued medical therapy for GER(up to 2 yrs)
- wrap failure and need for subsequent reoperation(up to 2 yrs)
- intraoperative complication rates(duration of procedure)