GERDCCGERDNCT01899183
Surgery in Chronic Cough GERD Related
An observational study of GERD, run by University of Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Anti-reflux Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- Jan 1995to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: GERD and Chronic Cough (< 8 weeks).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Medical And Surgical Sciences University of Bologna
Bologna, BO, 40138
About this study
Official title: 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.
Read the 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.
- Conditions
- GERD
- Being tested
- Anti-reflux Surgery
- Keywords
- Chronic cough, Esophagus, Gastro-esophageal reflux disease, Esophageal surgery, Minimally invasive surgery, Extra-esophageal reflux symptoms.
- Medical subject headings
- Gastroesophageal Reflux, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-reflux SurgeryProcedure or surgery
Nissen Fundoplication; Collis Gastroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: minimum 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJan 1995
- Primary completionDec 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Mattioli, University of Bologna
- Investigators
- Sandro Mattioli, MD, Principal investigator, Departement of Medical and Surgical Sciences University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899183
- Sponsor's protocol ID
- Chronic Cough and GERD
- Acronym
- CCGERD
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Anti-reflux Surgery for the Cure of Chronic Cough Associated With Gastro-oesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01899183
- Acronym / sponsor ID
- CCGERD / Chronic Cough and GERD
- Conditions
- GERD
- Keywords
- Chronic cough, Esophagus, Gastro-esophageal reflux disease, Esophageal surgery, Minimally invasive surgery, Extra-esophageal reflux symptoms.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Jan 1995
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- GERD and Chronic Cough (< 8 weeks).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-reflux SurgeryNissen Fundoplication; Collis Gastroplasty | Procedure or surgery | – |
Primary outcome
Global Results and Resolution of chronic cough
Time frame: minimum 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Department of Medical and Surgical Sciences University of BolognaLink provided by the sponsor.
Related trials for GERD
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
RecruitingObservational study
Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Mattioli, MD principal investigator
Departement of Medical and Surgical Sciences University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Results and Resolution of chronic cough (time frame: minimum 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2013.