Gastro -Oesophagal Reflux, Laryngo-pharyngeal Reflux
Conditions
Keywords
TIF, cTIF, GORD, GERD, Endoscopic intervention, Endoscopy, reflux
Brief summary
This is a European, multi-centre, prospective registry that aims to determine the safety and efficacy of transoral incisionless fundoplication, with or without concomitant hiatal hernia repair, for the treatment of patients with gastro-oesophageal reflux disease (GORD).
Interventions
DEVICETransoral incisionless fundoplication with or without concomitant hiatal hernia repair with the EsophyX device
Transoral Incisionless Fundoplication (TIF): The TIF procedure is an endoscopic, minimally invasive intervention designed to reconstruct the gastro-oesophageal valve and restore its function as a reflux barrier, without external incisions. The procedure is performed transorally using the EsophyX device under general anaesthesia. The device enables the creation of a 270° to 300° esophagogastric fundoplication. Concomitant TIF (cTIF): The cTIF procedure combines a laparoscopic hiatal hernia repair with the TIF performed in the same session. Patients with a hiatal hernia greater than 2 cm undergo laparoscopic reduction and crural repair, followed immediately by the TIF procedure using the EsophyX device. This combined approach addresses both the anatomical defect of the hiatal hernia and the functional deficiency of the gastro-oesophageal valve.
Sponsors
Cleveland Clinic London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any adult patient (≥18 years old) undergoing TIF2.0 or cTIF, at a participating centre, who can understand and sign the informed consent form, and is conducted in line with local institutional review board approval and recommendations.
Exclusion criteria
* There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastroesophageal reflux disease health-related quality of life questionnaire (GERD-HRQL) | 6-months, 1-year, 2-year, 3-years, 5-, years | Change in reflux-specific quality of life questionnaires (The GERD-HRQL used in the study is composed of 16 questions related to symptoms of heartburn, regurgitation, swallowing and overall satisfaction. Each question provides a scaled score between 0-5 (0=no symptoms, 5= Symptoms incapacitating to do daily activities) with a total score of 75.) |
| Reflux symptom index (RSI) | 6-months, 1-year, 2-years, 3-years, 5-years | Change in reflux-specific quality of life questionnaire (The RSI used in the study is composed of 9 questions related to atypical symptoms of reflux or 'LPR'. Each question provides a scaled score between 0-5 (0=no problems, 5=severe problems) with a total score of 45.) |
| Proton pump inhibitor and/or histamine-2 receptor antagonist use | 6-months, 1-year, 2-years, 3-years, 5-years | Change in acid suppression use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological reflux testing | up to 5-years | Change in pH physiological testing |
| Procedural outcomes (technical success) | 30-days | Defined as successful completion of all steps of the cTIF or TIF2.0 procedure in the same sitting |
| Procedural outcomes (duration) | 30-days | Total length of the procedure in minutes |
| Procedural outcomes (length of hospital stay | 30-days | The time in days from procedure to discharge from hospital |
| Adverse events | up to 30-days | Adverse events (AE) following TIF2.0 according to the AGREE classification |
| Adverse events of special interest | Up to 5-years | Subjective reporting of dysphagia, excessive belching or inability to belch, significant bloating and/or distension, and persistent nausea and vomiting. |
| Need for revisional procedure | Up to 5-years | The need for repreat endoscopic or surgical intervention due to recurrence of symptoms, failure of procedure of adverse events |
Countries
Austria, Italy, Serbia, Switzerland, Turkey (Türkiye), United Arab Emirates, United Kingdom
Outcome results
None listed