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Necessity of Esophageal Dissection During Laparoscopic Fundoplication

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ClinicalTrials.gov Identifier: NCT00287612
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : September 22, 2009
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
Children's Mercy Hospital Kansas City

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

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Hiatal Hernia Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children
Study Start Date : February 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Experimental: 2 Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction
phrenoesophageal membrane left intact


Outcome Measures
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Primary Outcome Measures :
  1. Hiatal hernia [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. control of symptoms [ Time Frame: 1 year ]
  2. retching [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287612


Locations
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United States, Alabama
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
University of Alabama at Birmingham
Investigators
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Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
More Information
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Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00287612    
Other Study ID Numbers: 05 12-150
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: March 2009
Keywords provided by Children's Mercy Hospital Kansas City:
GERD
Hiatal Hernia
Recurrence
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Hernia
Hernia, Hiatal
Pathological Conditions, Anatomical
Esophageal Motility Disorders
 Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hernia, Diaphragmatic