Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Study Overview
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Brief Summary
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The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.

Detailed Description
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The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate expertise bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.

Official Title
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A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Conditions
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Gastroesophageal Reflux, Esophageal Reflux, Gastroesophageal Reflux Disease, GERD

Intervention / Treatment
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* Procedure: Laparoscopic Hill Repair
* Procedure: Laparoscopic Nissen Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control > 18 years of age and < 75 years of age Exclusion Criteria: hiatal hernias measuring > 7 cm esophageal body amplitude < 30 or in two or more segments < 40% propagated peristaltic waves GE junction > 5 cm above the esophageal hiatus dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy body mass index > 40

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Laparoscopic Hill | Procedure: Laparoscopic Hill Repair<br>* With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.<br>|
| Active Comparator: Arm B<br>Laparoscopic Nissen | Procedure: Laparoscopic Nissen Repair<br>* With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). | Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, laparoscopic surgery, gastroesophageal, reflux