Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Procedure: Nissen fundoplication


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open nissen fundoplication<br>open repair through surgical midline incision | Procedure: Nissen fundoplication<br> <br> |
| Active Comparator: laparoscopic nissen fundoplication<br>use of laparoscope to do repair | Procedure: Nissen fundoplication<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative length of stay | days in hospital | 0 to 14days | 
| postoperative narcotic pain medication requirements | days requiring narcotics for pain relief | 0 to 14 days | 
| length of time to tolerating full feeds prior to discharge | days after surgery before feeding begins | 0 to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complication rates | complications of procedure | duration of procedure | 
| wrap failure and need for subsequent reoperation | operative failure | up to 2 yrs | 
| need for continued medical therapy for GER | symptomatic reflux requiring medication | up to 2 yrs | 
| death | death | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nissen fundoplication, gastroesophageal reflux