Clinical Trial Comparing Open and Laparoscopic Nissen Fundoplication in Children

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382850
• Other study ID #: 05-08-01-01
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: November 30, 2010

Study information

• Verified date: July 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 30, 2010
• Est. primary completion date: November 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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)

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Procedure:
• Nissen fundoplication

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative length of stay	days in hospital	0 to 14days
Primary	postoperative narcotic pain medication requirements	days requiring narcotics for pain relief	0 to 14 days
Primary	length of time to tolerating full feeds prior to discharge	days after surgery before feeding begins	0 to 7 days
Secondary	intraoperative complication rates	complications of procedure	duration of procedure
Secondary	wrap failure and need for subsequent reoperation	operative failure	up to 2 yrs
Secondary	need for continued medical therapy for GER	symptomatic reflux requiring medication	up to 2 yrs
Secondary	death	death	up to 2 years