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Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Johns Hopkins University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382850
First Posted: October 2, 2006
Last Update Posted: April 6, 2007
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.
Information provided by:
Johns Hopkins University
  Purpose
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.

Condition Intervention
Gastroesophageal Reflux Procedure: Nissen fundoplication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic Compared to Open Nissen Fundoplication in Children Younger Than 2 Years of Age

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • postoperative length of stay
  • postoperative narcotic pain medication requirements
  • length of time to tolerating full feeds prior to discharge

Secondary Outcome Measures:
  • intraoperative complication rates
  • wrap failure and need for subsequent reoperation within 2 years
  • need for continued medical therapy for GER at 2 years
  • death

Estimated Enrollment: 68
Study Start Date: November 2005
Estimated Study Completion Date: November 2010
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382850


Contacts
Contact: Meghan A Arnold, MD 410-955-2717 marnold@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Sub-Investigator: Meghan A Arnold, MD         
Sub-Investigator: Anne C Fischer, MD, PhD         
Sub-Investigator: Fizan Abdullah, MD, PhD         
Sub-Investigator: Margaret Birdsong, CPNP         
Sub-Investigator: Kimberly McIltrot, CRNP         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Paul M Colombani, MD Johns Hopkins University
  More Information

ClinicalTrials.gov Identifier: NCT00382850     History of Changes
Other Study ID Numbers: 05-08-01-01
First Submitted: September 29, 2006
First Posted: October 2, 2006
Last Update Posted: April 6, 2007
Last Verified: April 2007

Keywords provided by Johns Hopkins University:
Nissen fundoplication
gastroesophageal reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases