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

NCT07634614 | Enrolling By Invitation

• 1 other identifier: 2025-02635
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• 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.

  Comparison of air-associated symptoms and their impact on daily life before and after targeted speech and language therapy in patients with GERD.

  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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective patients are identified through the upper gastrointestinal surgery data base of our institution. All patients who meet the inclusion criteria by having received the intervention which is subject to be studied will be contacted and recruited for the study. There is no participant payment or compensation for enrolment in the study.

You may qualify if:

• 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

You may not qualify if:

• Age under 18 years
• Pregnancy
• 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)

Sponsors & Collaborators

• Prof Urs Zingg: lead

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Urs Zingg, Prof. Dr. med-

  Spital Limmattal Schlieren

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Departement of Operative Disciplines

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 9, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CH (1)