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Prospective Randomized Trial Evaluating the Utility of Esophageal Stitches During Laparoscopic Fundoplication

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status

Completed

Conditions

Reflux

Treatments

Procedure: esophageal stitches during fundoplication
Procedure: no esophageal stitches placed during fundoplication

Study type

Interventional

Funder types

Other

Identifiers

NCT01509352
10 01-003

Details and patient eligibility

About

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.

Full description

This will be a single center, prospective randomized clinical trial involving patients who require an operation for gastroesophageal reflux disease. This is intended to be a definitive study. All patients will receive the standard operation for reflux: laparoscopic fundoplication. The dissection will be performed by leaving the phrenoesophageal membrane intact in all patients.

One group will undergo laparoscopic fundoplication with 4 esophageal-crural sutures while the other group will not have these placed. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.

Enrollment

65 patients

Sex

All

Ages

1 day to 7 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

  1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography, endoscopy, or intraoperative findings.
  2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
  3. Prior operation for congenital diaphragmatic hernia
  4. 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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65 participants in 2 patient groups

with esophageal stitches
Active Comparator group
Description:
fundoplication with crural stitches
Treatment:
Procedure: esophageal stitches during fundoplication
without esophageal stitches
Experimental group
Description:
fundoplication without crural stitches.
Treatment:
Procedure: no esophageal stitches placed during fundoplication

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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