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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01509352

Enrollment

Registered

2012-01-13

Start date

2010-02-28

Completion date

2015-03-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux

Keywords

fundoplication, gastric reflux

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.

Detailed 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.

Interventions

PROCEDUREesophageal stitches during fundoplication

placement of esophageal stitches with fundoplication

PROCEDUREno esophageal stitches placed during fundoplication

no esophageal stitches are placed during the fundoplication procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 7 Years

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)

Design outcomes

Primary

Measure	Time frame
hiatal herniation	4 year follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026