Surgery in Chronic Cough GERD Related

NCT01899183 | Completed

• 1 other identifier: Chronic Cough and GERD
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GERD

Keywords

Chronic cough; Esophagus; Gastro-esophageal reflux disease; Esophageal surgery; Minimally invasive surgery; Extra-esophageal reflux symptoms.

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Anti-reflux Surgery PROCEDURE

Nissen Fundoplication; Collis Gastroplasty

Eligibility Criteria

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

Study Population

GERD and Chronic Cough (\< 8 weeks).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Department of Medical And Surgical Sciences University of Bologna

Bologna, BO, 40138, Italy

Location

Related Links

• Department of Medical and Surgical Sciences University of Bologna

MeSH Terms

Conditions

Gastroesophageal Reflux; Chronic Cough

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandro Mattioli, MD

  Departement of Medical and Surgical Sciences University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 15, 2013
• Study Start: January 1, 1995
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2012
• Last Updated: July 15, 2013

Record last verified: 2013-07

Locations

IT (1)