Registry to Compare Two Surgical Treatments for GERD

NCT02211105 | Terminated DMC

• 1 other identifier: AGA STAR Registry
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this prospective observational research study registry is to examine whether two GERD surgeries (Laparoscopic Nissen Fundoplication (LNF) or Transoral Incisionless Fundoplication (TIF)) have similar outcomes in effectiveness, safety, post-operative side effects and post-procedure costs associated with episodes of care and any ensuing complications.

Conditions

GastroEsophageal Reflux Disease

Keywords

GastroEsophageal Reflux Disease; Transoral Incisionless Fundoplication; Laparoscopic Nissen Fundoplication

Outcome Measures

Primary Outcomes (1)

• Effectiveness as measured by a 75% reduction in GERD HRQL)

  To compare the effectiveness of TIF and LNF at the end of three years compared to baseline using a 75% reduction in GERD Health-related Quality of Life (GERD-HRQL) as a threshold for effectiveness.

  3 years

Secondary Outcomes (1)

• Effectiveness using a 50% reduction in GERD-HRQL

  3 years

Other Outcomes (3)

• Durability of GERD surgeries

  1 year and 3 years

• Comparison of TIF to LNF for Patient reported symptoms

  3 years

• Comparison of Post-Procedure cost

  3 years

Study Arms (2)

Laparoscopic Nissen Fundoplication

Patients whose GERD is being treated surgically through Laparoscopic Nissen Fundoplication.

Transoral Incisionless Fundoplication

Patients whose GERD is being treated surgically through Transoral Incisionless Fundoplication.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who meet clinical criteria and have decided to treat their GERD through one of two surgical procedures, (LNF or TIF) and agree to have their standard GI medical data for 3 years.

You may qualify if:

• GERD symptoms (heartburn, defined by a sub-sternal burning discomfort arising from the upper abdomen into the chest, and or regurgitation, defined as the effortless arising of liquid material into the chest or mouth) two or more times a week (when not on anti-secretory medication) that adversely affects the patient's quality of life. Additionally, patients will have to have responded to medical therapy (adequate relief of symptoms) as indicated by GERD-HRQL and regurgitation scores on medical therapy. In this context, scores ≤ 2 on each GERD-HRQL and regurgitation question (while on medication) indicate absence of daily bothersome symptoms and therefore these patients are considered responsive to medical therapy. Furthermore, patients will have to have objective evidence of GERD documented (esophagitis on endoscopy or pathological intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring).
• Age 18-80 years
• Ability to give informed consent
• Regular access to a telephone
• Meet the clinical criteria for treatment of GERD with TIF or LNF and undergo TIF or LNF within 90 days of providing consent.
• Dependent upon PPIs for control of heartburn for \> six months or patient determined to have an inadequate response of regurgitation symptoms despite heartburn control with PPIs
• Hiatal hernia axial length is no larger than 2 cm and the transverse dimension should not exceed 2.0 cm
• Gastroesophageal junction with a Hill Grade I-II
• \--- Patient willing to provide informed consent, cooperate with post-operative dietary recommendations and follow-up assessment tests
• Objective documentation of pathological acid-reflux by either a) increased intraesophageal acid exposure on prolonged ambulatory esophageal pH monitoring (pH\<4 for 4.5% or greater of the time) with or without impedance b) or the presence of erosive esophagitis (LA Grade A or B) on endoscopy
• Absence of a severe esophageal motility disorder (note: mild abnormalities in esophageal motility are common in GERD such as small breaks, etc.) including achalasia, esophagogastric junction outflow obstruction, frequent failed peristalsis, diffuse esophageal spasm, nutcracker or jackhammer esophagus etc. on high-resolution esophageal manometry using the Chicago classification system or evidence of incomplete bolus clearance on 30% or more of swallows by impedance testing.

You may not qualify if:

• Hiatal hernia \> 2 cm (defined as longitudinal length measured endoscopically between the proximal margin of the gastric folds and the diaphragmatic pinch)
• Esophagitis LA Grade C or D
• Presence of troublesome atypical symptoms
• Barrett's esophagus greater than 2 cm in length or with any dysplasia
• Esophageal stricture or severe esophageal motility disorder
• History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, cirrhosis or any other uncontrolled systemic disease
• Active gastro-duodenal ulcer disease
• Gastric outlet obstruction or stenosis
• Gastroparesis or delayed gastric emptying confirmed by a four hour solid-phase gastric emptying study
• Body Mass Index (BMI) \> 35
• Pregnancy or plans for pregnancy within 12 months of the procedure
• Portal hypertension and/or varices
• New York Heart Association classification of III or IV.
• Coagulation disorders
• Intraprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe performance of the procedure

Sponsors & Collaborators

• American Gastroenterological Association: lead
• EndoGastric Solutions: collaborator

Study Sites (10)

OC Reflux

Huntington Beach, California, United States

Location

SurgOne Foregut Institute

Englewood, Colorado, 80110, United States

Location

GI Solutions Inc

Chicago, Illinois, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Lenox Hill Hospital

New York, New York, 10011, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

University of Texas at Houston

Bellaire, Texas, 77401, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79912, United States

Location

Reston Hospital Center/ GW University

Reston, Virginia, 20190, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• M. Brian Fennerty, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• W. Scott Melvin, M.D.

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

• Ashish Atreja, M.D.

  MOUNT SINAI HOSPITAL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 7, 2014
• Study Start: July 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2017-04

Locations

US (10)