Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

NCT ID: NCT01260935

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2010-11-30

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.

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.

Conditions

Gastroesophageal Reflux; Esophageal Reflux; Gastroesophageal Reflux Disease; GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm A

Laparoscopic Hill

Group Type: ACTIVE_COMPARATOR

Laparoscopic Hill Repair

Intervention Type: 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.

Arm B

Laparoscopic Nissen

Group Type: ACTIVE_COMPARATOR

Laparoscopic Nissen Repair

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralph Aye, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center Cancer Institute

Locations

Swedish Medical Center Cancer Institute

Seattle, Washington, United States

Countries

United States

Other Identifiers

IR 3722

Identifier Type: -

Identifier Source: org_study_id