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Effect of dilating the gastro-esophageal junction on prolonged dysphagia after anti-reflux operation.


- candidate number22326
- NTR NumberNTR5247
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jun-2015
- Secondary IDsNL50376.018.14 
- Public TitleEffect of dilating the gastro-esophageal junction on prolonged dysphagia after anti-reflux operation.
- Scientific TitleEffect of pneumodilatation of the EGJ in patients with prolonged dysphagia after fundoplication.
- ACRONYMDAFFODIL trial (Dysphagia After Fundoplication: eFfect Of Dilatation)
- hypothesisThe aim of the study is to compare the efficacy of pneumodilatation with 'sham'-treatment (placebo intervention). It is hypothesized that pneumodilatation will resolve dysphagia faster than sham dilatation.
- Healt Condition(s) or Problem(s) studiedGastroesophageal reflux Disease (GERD), Pneumodilation, Dysphagia
- 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
• Eckardt symptom score ≥ 4
• Written informed consent
• Age above 18 years
- Exclusion criteria• Significant dysphagia before surgery
• Previous dilatation for dysphagia
• History of (pseudo)achalasia
• Anatomical defects causing dysphagia (slipped, malpositioned or herniated fundoplication)
• Allergy to barium sulfate
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate1-jun-2017
- Target number of participants42
- InterventionsPatients with persistent dysphagia more than 3 months postoperatively will be randomized to either pneumatic dilatation or to sham dilatation.

Pneumatic dilatation: During endoscopy under sedation. The Rigiflex 35 mm balloon will be positioned in the lower esophageal sphincter (LES) area (x-rays can be used or this can be done under direct endoscopic guidance) and inflated to 35mm at 8 psi and maintained until the “waist” of the balloon is obliterated, or for at least one minute.

Sham dilatation: This endoscopy will also be performed under sedation. However, no dilatation or other intervention will be performed.

The patient is blinded to the treatment.

Participating sites:
- Academic Medical Center, Amsterdam
- Meander Medical Center, Amersfoort
- University Hospital Leuven, Leuven
- Maastricht University Medical Center, Maastricht
- St Antonius Hospital, Nieuwegein
- Primary outcomeDysphagia symptom severity (Eckardt score)
- Secondary outcome• Reflux symptom severity (Reflux disease questionnaire; RDQ)
• Health related Quality of life (SF-36)
• Impaction dysphagia questionnaire (IDQ)
• 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
- TimepointsBaseline: high-resolution manometry, barium esophagography, informed consent, questionnaires

Day 1 (visit 1): Endoscopy with pneumodilatation or sham dilatation

Day 7: Questionnaires by telephone or mail.

Day 30 (visit 2): high-resolution manometry, barium esophagography, questionnaires

Questionnaires are: Eckardt score, Short form-36 (health related quality of life), Reflux disease questionnare (RDQ), Impaction dysphagia questionnaire (IDQ)
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. A.J. Bredenoord
- CONTACT for SCIENTIFIC QUERIESDr. A.J. Bredenoord
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), University of Amsterdam
- PublicationsN/A
- Brief summaryRationale: The prevalence of gastroesophageal reflux disease (GERD) is 10-20% in the western world. Typical symptoms are heartburn and regurgitation. The most effective treatment is laparoscopic fundoplication, in which the fundus of the stomach (partially) placed around the distal esophagus. Postoperative dysphagia is usually self-limiting within 2-6 weeks. In 5-10% of patients however, prolonged dysphagia is seen (> 3 months postoperatively). Treatment options are an expectative approach or dilation of the lower esophageal sphincter and surgically constructed wrap around it. Pneumodilation (PD) is generally believed to be the most effective dilatation technique, but it has never been shown that dilation of the LES and wrap is actually more effective than the expectative approach.
Objective: To evaluate the effect of pneumodilatation (PD) on prolonged dysphagia after Toupet or Nissen fundoplication compared to sham dilatation. Study design: This is an interventional, multicentre trial. Either pneumodilatation or sham dilation is performed in a randomized, single-blinded manner.
Study population: 42 adult patients with prolonged dysphagia (> 3 months) after primary Nissen or Toupet fundoplication for GERD.
Intervention: In one group a pneumodilatation is performed and in the other group a sham dilatation (endoscopy without intervention) is performed . Main study endpoints: Dysphagia symptom severity (Eckardt score).
- Main changes (audit trail)
- RECORD10-jun-2015 - 15-aug-2015


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