Status:
COMPLETED
Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
Lead Sponsor:
Swedish Medical Center
Conditions:
Gastroesophageal Reflux
Esophageal Reflux
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 bett...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01260935
Start Date
November 1 2002
End Date
November 1 2010
Last Update
January 18 2012
Active Locations (1)
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1
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104