Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260935
• Other study ID #: IR 3722
• Status: Completed
• Phase: N/A
• First received: November 30, 2010
• Last updated: January 16, 2012
• Start date: November 2002
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Swedish Medical Center Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No