Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux; Esophageal Reflux; Gastroesophageal Reflux Disease; GERD
• Interventions: Procedure: Laparoscopic Hill Repair; Procedure: Laparoscopic Nissen Repair

• Registration Number: NCT01260935
• Lead Sponsor: Swedish Medical Center

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.

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Laparoscopic Hill Repair	Laparoscopic Hill
Arm B	Laparoscopic Nissen Repair	Laparoscopic Nissen

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Swedish Medical Center Cancer Institute; 🇺🇸 Seattle, Washington, United States