Surgery in Chronic Cough GERD Related

GERD Clinical Trial

— CCGERD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899183
• Other study ID #: Chronic Cough and GERD
• Status: Completed
• Phase: N/A
• First received: July 3, 2013
• Last updated: July 10, 2013
• Start date: January 1995
• Est. completion date: January 2012

Study information

• Verified date: July 2013
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of HealthItaly: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Procedure:
• Anti-reflux Surgery
Nissen Fundoplication; Collis Gastroplasty

Locations

Country	Name	City	State
Italy	Department of Medical And Surgical Sciences University of Bologna	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Department of Medical and Surgical Sciences University of Bologna