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


N/A
18 Years
75 Years
Not Enrolling
Both
Gastroesophageal Reflux, Esophageal Reflux, Gastroesophageal Reflux Disease, GERD

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Ralph Aye, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Medical Center Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

IR 3722

NCT ID:

NCT01260935

Start Date:

November 2002

Completion Date:

November 2010

Related Keywords:

  • Gastroesophageal Reflux
  • Esophageal Reflux
  • Gastroesophageal Reflux Disease
  • GERD
  • GERD
  • laparoscopic surgery
  • gastroesophageal
  • reflux
  • Esophageal Diseases
  • Gastroesophageal Reflux

Name

Location
Swedish Medical Center Cancer Institute Seattle, Washington  98104