Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

Swedish Medical Center

Status: Completed

Conditions: Gastroesophageal Reflux Disease; Gastroesophageal Reflux; Esophageal Reflux; GERD

Treatments: Procedure: Laparoscopic Nissen Repair; Procedure: Laparoscopic Hill Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01260935

IR 3722

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

121 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Laparoscopic Hill

Treatment:

Procedure: Laparoscopic Hill Repair

Arm B

Active Comparator group

Description:

Laparoscopic Nissen

Treatment:

Procedure: Laparoscopic Nissen Repair