Clinical trial NCT00287612: Necessity of Esophageal Dissection During Laparoscopic Fundoplication
Official title: Prospective Trial Comparing Utility of Esophageal Crural Dissection During Laparoscopic Fundoplication in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Hiatal Hernia
Keywords: GERD
Hiatal Hernia
Recurrence
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2006-02-07
Enrollment: 177
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Hiatal hernia
timeFrame: 1 year
Secondary outcomes:
measure: control of symptoms
timeFrame: 1 year
measure: retching
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Shawn D St. Peter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Does de Willebois EML; SPICY study group. Mesenteric SParIng versus extensive mesentereCtomY in primary ileocolic resection for ileocaecal Crohn's disease (SPICY): study protocol for randomized controlled trial. BJS Open. 2022 Jan 6;6(1):zrab136. doi: 10.1093/bjsopen/zrab136.