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Enrolling by invitation NCT07634614

Pre- and Post-Therapy Evaluation of Air-Associated Symptoms in Patients With Gastro-esophageal Reflux Disease (GERD): Assessing the Role of Speech and Language Therapy

Observational GERD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: GERD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Patients with gastroesophageal reflux disease (GERD) may present with concomitant gas-related symptom (GRS) such as supragastric or gastric belching, and aerophagia. Identifying these patients is crucial, as their therapeutic pathway differs substantially from that of patients with "pure" reflux disease. Proceeding directly to antireflux surgery in the presence of untreated air-associated symptoms can lead to catastrophic postoperative outcomes. These partly behavioral disorders can often be effectively managed through targeted speech therapy. Following successful therapy, patients may either experience complete resolution of their symptoms or become suitable candidates for surgical treatment of GERD. As of today, there is very scarce literature on this subject.

Primary outcome measures

  • Comparison of air-associated symptoms and their impact on daily life before and after targeted speech and language therapy in patients with GERD, assessed using a specifically developed patient questionnaire. [Time frame: From start of speech therapy until interview: - Speech therapy was started earliest in January 2023, latest around January 2026. - Interviews are taking place starting in April 2026 until all have been performed, end is anticipated in fall 2026.]

Eligibility criteria

Inclusion criteria

  • Age 18 years and older
  • Initial presentation at our reflux center with reflux symptoms, with or without concomitant air-related symptoms such as belching, bloating, or abdominal distension
  • Confirmed air-related pathology based on characteristic clinical findings and/or diagnostic evidence from impedance, manometry, or videofluoroscopic swallow study (VFSS)
  • Verbal informed consent as documented by the investigator

Exclusion criteria

  • Age under 18 years
  • Pregnancy
  • Exclusion of GERD
  • Preoperative presence of a hiatal hernia with migration of >20% of stomach in the chest
  • Revisional surgery (after other procedures for reflux or at the hiatus)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Switzerland · 1 center
  • Spital Limmattal — Schlieren

Identifiers

NCT: NCT07634614 · 2025-02635

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗