NCT00382850

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2010

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

5.1 years

First QC Date

September 29, 2006

Last Update Submit

July 30, 2018

Conditions

Gastroesophageal Reflux

Keywords

Nissen fundoplicationgastroesophageal reflux

Outcome Measures

Primary Outcomes (3)

  • postoperative length of stay

    days in hospital

    0 to 14days

  • postoperative narcotic pain medication requirements

    days requiring narcotics for pain relief

    0 to 14 days

  • length of time to tolerating full feeds prior to discharge

    days after surgery before feeding begins

    0 to 7 days

Secondary Outcomes (4)

  • intraoperative complication rates

    duration of procedure

  • wrap failure and need for subsequent reoperation

    up to 2 yrs

  • need for continued medical therapy for GER

    up to 2 yrs

  • death

    up to 2 years

Study Arms (2)

open nissen fundoplication

ACTIVE COMPARATOR

open repair through surgical midline incision

Procedure: Nissen fundoplication

laparoscopic nissen fundoplication

ACTIVE COMPARATOR

use of laparoscope to do repair

Procedure: Nissen fundoplication

Interventions

Nissen fundoplicationPROCEDURE
laparoscopic nissen fundoplicationopen nissen fundoplication

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • clinical or radiographic diagnosis of gastroesophageal reflux
  • age less than 2 years (24 months) at the time of surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Paul M Colombani, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

November 1, 2005

Primary Completion

November 30, 2010

Study Completion

November 30, 2010

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations

US(1)