Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
1 other identifier
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 30, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedJanuary 18, 2012
January 1, 2012
8 years
November 30, 2010
January 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Arm A
ACTIVE COMPARATORLaparoscopic Hill
Arm B
ACTIVE COMPARATORLaparoscopic Nissen
Interventions
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.
With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swedish Medical Center Cancer Institute
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Aye, MD
Swedish Medical Center Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2010
First Posted
December 15, 2010
Study Start
November 1, 2002
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
January 18, 2012
Record last verified: 2012-01