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
  Purpose

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


Condition Intervention
Gastroesophageal Reflux Disease
Hiatal Hernia
Procedure: Lap. Fundo. with Mobilization of the Esophageal Junction
Procedure: Lap. Fundo. without Mobilization of the Esophageal Junction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Hiatal hernia [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • control of symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • retching [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: February 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287612

Locations
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
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital
  More Information

No publications provided

Responsible Party: Shawn St. Peter, Children's Mercy Hospital
ClinicalTrials.gov Identifier: NCT00287612     History of Changes
Other Study ID Numbers: 05 12-150
Study First Received: February 6, 2006
Last Updated: September 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Mercy Hospital Kansas City:
GERD
Hiatal Hernia
Recurrence

Additional relevant MeSH terms:
Gastroesophageal Reflux
Hernia
Hernia, Hiatal
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Hernia, Diaphragmatic

ClinicalTrials.gov processed this record on August 01, 2014