Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260935
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Esophageal Reflux Gastroesophageal Reflux Disease GERD Procedure: Laparoscopic Hill Repair Procedure: Laparoscopic Nissen Repair Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
Study Start Date : November 2002
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm A
Laparoscopic Hill
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.
Active Comparator: Arm B
Laparoscopic Nissen
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.

Primary Outcome Measures :
  1. Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260935

United States, Washington
Swedish Medical Center Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Principal Investigator: Ralph Aye, MD Swedish Medical Center Cancer Institute

Responsible Party: Swedish Medical Center Identifier: NCT01260935     History of Changes
Other Study ID Numbers: IR 3722
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Swedish Medical Center:
laparoscopic surgery

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases