Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
- Conditions
- Gastro Esophageal Reflux
- Interventions
- Device: Transoral incisionless fundoplication
- Registration Number
- NCT05066594
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.
- Detailed Description
After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions) Transoral incisionless fundoplication Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure.
- Primary Outcome Measures
Name Time Method Medical use and dosage Yearly, up to 5 years from the date of the intervention Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention
- Secondary Outcome Measures
Name Time Method Health Related Quality of Life questionnaire score Yearly, up to 5 years from the date of the intervention Modification of the scores from the gastro-esophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (absence of symptoms) to 5 (symptoms do not allow for normal daily activity), after intervention compared with baseline
Reflux Symptom Index questionnaire score Yearly, up to 5 years from the date of the intervention Modification of the scores from the reflux symptom index (GERD-RSI) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (no problem) to 5 (severe problem) after the intervention compared with baseline
High-resolution esophageal manometry findings 12 months after the date of the intervention Esophageal manometry measurements after the intervention
24-hour esophageal pH-metry findings 12 months and 24 months after the date of the intervention 24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention
Jobe's length of the gastro-esophageal valve 6 months and 12 months after the date of the intervention Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention
Barrett's esophagus 6 months and 12 months after the date of the intervention Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention
Esophagitis 6 months and 12 months after the date of the intervention Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention
Hill's grade of the gastro-esophageal flap valve 6 months and 12 months after the date of the intervention Degree of continence of the neo gastro-esophageal flap valve according to the Hill classification (grade I, grade II, grade III, grade IV) after the intervention
24-hour esophageal impedancemetry findings 12 months and 24 months after the date of the intervention 24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Milan, Italy