Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00382850
First received: September 29, 2006
Last updated: April 4, 2007
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00382850     History of Changes
Other Study ID Numbers: 05-08-01-01
Study First Received: September 29, 2006
Last Updated: April 4, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014