Esophageal Reflux, Gastroesophageal Reflux, Gastroesophageal Reflux Disease, GERD
Conditions
Keywords
GERD, laparoscopic surgery, gastroesophageal, reflux
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 better than the other.
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 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.
Interventions
PROCEDURELaparoscopic Hill Repair
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.
PROCEDURELaparoscopic Nissen Repair
With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.
Sponsors
Swedish Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). | 1 year | 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. |
Countries
United States
Outcome results
None listed