Effect of pneumodilatation in patients with prolonged dysphagia after antireflux surgery
Completed
- Conditions
- difficulty in swallowing after anti-reflux surgery10017977Postfundoplication dysphagia
- Registration Number
- NL-OMON47334
- Lead Sponsor
- Maag-, Darm- en Leverziekten
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
*Patients after primary Nissen or Toupet fundoplication for GERD
*Dysphagia that was not present before surgery and lasting for at least 3 months
*Informed consent
*Age above 18 years
Exclusion Criteria
*Significant dysphagia before surgery
*Previous dilatation for dysphagia
*History of (pseudo)achalasia
*Anatomical defects causing dysphagia
*Allergy to barium sulfate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dysphagia symptom severity (Eckardt score).</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Reflux symptom severity (Reflux disease questionnaire; RDQ)<br /><br>-Health related Quality of life (SF-36)<br /><br>-Height and width of stasis on barium esophagogram after one minute<br /><br>-High-resolution manometry (LES pressure, IRP-4)<br /><br>-Adverse events / complications<br /><br>-Change in body weight</p><br>