Clinical trial NCT00382850: Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
Official title: Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Nissen fundoplication
gastroesophageal reflux
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-10-02
Enrollment: 68
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* clinical or radiographic diagnosis of gastroesophageal reflux
* age less than 2 years (24 months) at the time of surgery

Exclusion Criteria:

* 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)

Primary outcomes:
measure: postoperative length of stay
timeFrame: 0 to 14days
measure: postoperative narcotic pain medication requirements
timeFrame: 0 to 14 days
measure: length of time to tolerating full feeds prior to discharge
timeFrame: 0 to 7 days
Secondary outcomes:
measure: intraoperative complication rates
timeFrame: duration of procedure
measure: wrap failure and need for subsequent reoperation
timeFrame: up to 2 yrs
measure: need for continued medical therapy for GER
timeFrame: up to 2 yrs
measure: death
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Paul M Colombani, MD
role: PRINCIPAL_INVESTIGATOR
References: