Surgery in Chronic Cough GERD Related (CCGERD)

Effectiveness of Anti-reflux Surgery for the Cure of Chronic Cough Associated With Gastro-oesophageal Reflux Disease

The effectiveness of surgical fundoplication in treating classical reflux symptoms is well documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly secondary to gastro-esophageal reflux disease (GORD) is far to be assessed.

The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15% to 95%; the spread of these data is largely attributable to disparate study design and methodology, patient selection, and outcome metrics.

In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough allegedly secondary to GERD and to eventually identify the preoperative clinical profile which could predict those positive effects, we considered two groups of patients presenting with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux surgery.

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Procedure: Anti-reflux Surgery

Detailed Description

Pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy and esophageal manometry.

The type and severity of symptoms and the grade of reflux oesophagitis were scored using a questionnaire with semi-quantitative scales.

The upper gastro-intestinal (GI) endoscopy, barium swallow and esophageal manometry were performed according to standard techniques; reflux esophagitis was reported according to the Los Angeles classification. In the absence of Los Angeles grade A or higher esophagitis, patient underwent a 24h pH-recording or intraluminal impedance/pH monitoring. Patients complaining of chronic cough were submitted to a specific work-up consisting of a chest High Resolution Computed Tomography (HRCT) scan, methacholine challenge test and spirometry in order to exclude pulmonary diseases.

Surgery was performed in patients negative for pulmonary diseases on chest HRCT scan, on methacholine challenge test and spirometry, in consideration of the fact that patients had been referred mainly for the therapy of chronic cough.

The study was started in 1995 and it was closed in 2010.

• Study Type: Observational
• Enrollment (Actual): 67

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40138
      • Department of Medical And Surgical Sciences University of Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

GERD and Chronic Cough (< 8 weeks).

Description

Inclusion Criteria:

patients aged > 18 years, affected by chronic cough (> 8 weeks)associated with GERD typical symptoms, negative for pulmonary diseases on chest HRCT scan, on methacholine challenge test and spirometry, undergoing anti-reflux surgery

Exclusion Criteria:

patients with chronic cough (> 8 weeks) positive for pulmonary diseases on chest High Resolution Computed Tomography (HRCT) scan, methacholine challenge test and spirometry; association of GERD with epiphrenic esophageal diverticulum, collagen diseases, undetermined esophageal motility disorders, redo antireflux surgery, previous surgery on the thoracic and abdominal esophagus and stomach,on the diaphragm.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Results and Resolution of chronic cough	Pre-operatively, patients routinely underwent the symptoms assessment, barium swallow, upper gastro-intestinal endoscopy, esophageal manometry, chest High Resolution Computed Tomography scan, methacholine challenge test and spirometry. Surgery was performed on patients positive for gastro-esophageal reflux disease and negative for pulmonary diseases. The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (form 0 = absence of symptoms or esophagitis, to 3 = severe symptoms and esophagitis.For the surgical results an evaluation scale , from "excellent" to "poor", was used.	minimum 12 months

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Sandro Mattioli, MD, Departement of Medical and Surgical Sciences University of Bologna

Publications and helpful links

Helpful Links

• Department of Medical and Surgical Sciences University of Bologna

Study record dates

Study Major Dates

• Study Start: January 1, 1995
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: July 10, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Estimate): July 15, 2013
• Last Update Submitted That Met QC Criteria: July 10, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Esophagus; Minimally invasive surgery; Chronic cough; Gastro-esophageal reflux disease; Esophageal surgery; Extra-esophageal reflux symptoms.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: Chronic Cough and GERD