Necessity of Esophageal Dissection During Laparoscopic Fundoplication

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00287612
First received: February 6, 2006
Last updated: September 21, 2009
Last verified: March 2009

February 6, 2006
September 21, 2009
February 2006
August 2009   (final data collection date for primary outcome measure)
Hiatal hernia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hiatal hernia
  • Recurrence of reflux
Complete list of historical versions of study NCT00287612 on ClinicalTrials.gov Archive Site
  • control of symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • retching [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • control of symptoms
  • retching
Not Provided
Not Provided
 
Necessity of Esophageal Dissection During Laparoscopic Fundoplication
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Hiatal Hernia
  • Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction
    Complete mobilization of the esophageal junction
  • 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
    Intervention: Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction
  • Experimental: 2
    Intervention: Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
August 2009
August 2009   (final data collection date for primary outcome measure)

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)
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00287612
05 12-150
Yes
Shawn St. Peter, Children's Mercy Hospital
Children's Mercy Hospital Kansas City
University of Alabama at Birmingham
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP