Effect of pneumodilatation in patients with prolonged dysphagia after antireflux surgery

Effect of pneumodilatation in patients with prolonged dysphagia after antireflux surgery - DAFFODIL STUDY: Dysphagia After Fundoplication: eFfect Of DILatation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47334

Enrollment

Registered

2014-10-16

Start date

2015-03-10

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

difficulty in swallowing after anti-reflux surgery Postfundoplication dysphagia

Interventions

One group receives a pneumatic dilation (once), and one group receives a sham-dilation (endoscopy without intervention).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: *Significant dysphagia before surgery *Previous dilatation for dysphagia *History of (pseudo)achalasia *Anatomical defects causing dysphagia *Allergy to barium sulfate

Design outcomes

Primary

Measure	Time frame
Dysphagia symptom severity (Eckardt score).	—

Secondary

Measure	Time frame
-Reflux symptom severity (Reflux disease questionnaire; RDQ) -Health related Quality of life (SF-36) -Height and width of stasis on barium esophagogram after one minute -High-resolution manometry (LES pressure, IRP-4) -Adverse events / complications -Change in body weight	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)