Necessity of Esophageal Dissection During Laparoscopic Fundoplication

September 21, 2009 updated by: Children's Mercy Hospital Kansas City

Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children

This study compares complete dissection of the tissue around the lower esophagus to no dissection of these tissues during laparoscopic fundoplication in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This will be a 2-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 either separating the phrenoesophageal membrane, or by leaving the phrenoesophageal membrane intact.

Sample size calculated on a power of 80% with an alpha level of 0.05 using the recurrence rates demonstrated by our retrospective data produce a number of 159 patients in each arm of the study. Given that we will need to follow these patients for 1 year after enrollment, there may be some attrition due to lost follow-up. Therefore 180 patients per arm would account for just over 10% attrition.

One group will undergo laparoscopic fundoplication with complete mobilization of the lower esophagus by circumferentially dividing the phrenoesophageal membrane. The other group will undergo laparoscopic fundoplication without dividing this membrane. The operation, post-operative care, and follow-up plan will otherwise not differ between groups.

If 4 consecutive recurrences are found in one group, an interim analysis will be conducted. If a recurrence difference between groups of statistical significance is detected, the study will be concluded at this point. Without this occurrence, an interim analysis will be conducted at 180 patients enrolled.

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Children's Hospital of Alabama
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Under 18 years of age
  • Gastroesophageal Reflux Disease

Exclusion Criteria:

  1. Hiatal hernia demonstrated on preoperative contrast study, computed tomography or endoscopy
  2. Prior esophageal operation (e.g. esophageal atresia repair, esophageal myotomy)
  3. Prior operation for congenital diaphragmatic hernia
  4. Patient or family circumstance that will create difficulty attaining one-year follow-up (e.g. referral from distance or anticipated relocation of family)
  5. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction
phrenoesophageal membrane left intact
Active Comparator: 1
Arms:Lap. Fundo. with Mobilization of the Esophageal Junction
Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction
Complete mobilization of the esophageal junction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hiatal hernia
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
control of symptoms
Time Frame: 1 year
1 year
retching
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 21, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05 12-150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe