Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01260935
First received: November 30, 2010
Last updated: January 16, 2012
Last verified: January 2012
  Purpose

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 Intervention
Gastroesophageal Reflux
Esophageal Reflux
Gastroesophageal Reflux Disease
GERD
Procedure: Laparoscopic Hill Repair
Procedure: Laparoscopic Nissen Repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 121
Study Start Date: November 2002
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260935

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

No publications provided

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01260935     History of Changes
Other Study ID Numbers: IR 3722
Study First Received: November 30, 2010
Last Updated: January 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
GERD
laparoscopic surgery
gastroesophageal
reflux

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

ClinicalTrials.gov processed this record on July 22, 2014