Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children
Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: open nissen fundoplication
open repair through surgical midline incision
|
|
|
Active Comparator: laparoscopic nissen fundoplication
use of laparoscope to do repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative length of stay
Time Frame: 0 to 14days
|
days in hospital
|
0 to 14days
|
|
postoperative narcotic pain medication requirements
Time Frame: 0 to 14 days
|
days requiring narcotics for pain relief
|
0 to 14 days
|
|
length of time to tolerating full feeds prior to discharge
Time Frame: 0 to 7 days
|
days after surgery before feeding begins
|
0 to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraoperative complication rates
Time Frame: duration of procedure
|
complications of procedure
|
duration of procedure
|
|
wrap failure and need for subsequent reoperation
Time Frame: up to 2 yrs
|
operative failure
|
up to 2 yrs
|
|
need for continued medical therapy for GER
Time Frame: up to 2 yrs
|
symptomatic reflux requiring medication
|
up to 2 yrs
|
|
death
Time Frame: up to 2 years
|
death
|
up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul M Colombani, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-08-01-01
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