NCT01260935

Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux
• Esophageal Reflux
• Gastroesophageal Reflux Disease
• GERD

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic 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.
PROCEDURE	Laparoscopic 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.

Timeline

• Start date: 2002-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-12-15
• Last updated: 2012-01-18

Locations

1 site across 1 country: United States