Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382850
Recruitment Status : Unknown
Verified April 2007 by Johns Hopkins University.
Recruitment status was:  Recruiting
First Posted : October 2, 2006
Last Update Posted : April 6, 2007
Information provided by:
Johns Hopkins University

September 29, 2006
October 2, 2006
April 6, 2007
November 2005
Not Provided
  • postoperative length of stay
  • postoperative narcotic pain medication requirements
  • length of time to tolerating full feeds prior to discharge
Same as current
Complete list of historical versions of study NCT00382850 on Archive Site
  • intraoperative complication rates
  • wrap failure and need for subsequent reoperation within 2 years
  • need for continued medical therapy for GER at 2 years
  • death
Same as current
Not Provided
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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
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Gastroesophageal Reflux
Procedure: Nissen fundoplication
Not Provided
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
November 2010
Not Provided

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)
Sexes Eligible for Study: All
up to 24 Months   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Johns Hopkins University
Not Provided
Principal Investigator: Paul M Colombani, MD Johns Hopkins University
Johns Hopkins University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP