NCT01509352

Brief Summary

This is a prospective trial of the utility of esophageal stitches during fundoplication. The hypothesis is that recurrence rate may be different with or without the esophageal stitches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

5 years

First QC Date

December 14, 2011

Last Update Submit

January 25, 2017

Conditions

Reflux

Keywords

fundoplicationgastric reflux

Outcome Measures

Primary Outcomes (1)

  • hiatal herniation

    4 year follow-up

Study Arms (2)

with esophageal stitches

ACTIVE COMPARATOR

fundoplication with crural stitches

Procedure: esophageal stitches during fundoplication

without esophageal stitches

EXPERIMENTAL

fundoplication without crural stitches.

Procedure: no esophageal stitches placed during fundoplication

Interventions

esophageal stitches during fundoplicationPROCEDURE

placement of esophageal stitches with fundoplication

Also known as: crural stitches.
with esophageal stitches
no esophageal stitches placed during fundoplicationPROCEDURE

no esophageal stitches are placed during the fundoplication procedure

Also known as: crural stitches
without esophageal stitches

Eligibility Criteria

Age1 Day - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients less than 7 years of age requiring fundoplication for gastroesophageal reflux disease who are considered good laparoscopic candidates by the staff surgeon will be considered candidates.

You may not qualify if:

  • Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
  • Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
  • Prior operation for congenital diaphragmatic hernia
  • Patients not considered laparoscopic candidates by the staff surgeon or anesthesiologist (e.g. carbon dioxide retaining lung disease, congenital heart disease, or complex previous abdominal operations)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2011

First Posted

January 13, 2012

Study Start

February 1, 2010

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)