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Completed

NCT Number: NCT01260935

Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Esophageal Reflux GERD Gastroesophageal Reflux Disease Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swedish Medical Center Cancer Institute

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Hill Repair

Procedure

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

Procedure

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2010
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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