Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Sponsor

Swedish Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01260935

Collaborator

(none)

121

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Nov 1, 2002

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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