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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00287612
Other study ID # 05 12-150
Secondary ID
Status Completed
Phase N/A
First received February 6, 2006
Last updated September 21, 2009
Start date February 2006
Est. completion date August 2009

Study information

Verified date March 2009
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Lap. Fundo. with Mobilization of the Esophageal Junction
Complete mobilization of the esophageal junction
Lap. Fundo. without Mobilization of the Esophageal Junction
phrenoesophageal membrane left intact

Locations

Country Name City State
United States Children's Hospital of Alabama Birmingham Alabama
United States Children's Mercy Hospital Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hiatal hernia 1 year No
Secondary control of symptoms 1 year No
Secondary retching 1 year No
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