Overview
This is a spontaneous, prospective, monocentric, observational, cohort study, with the aim of evaluating the effect of ultrasound-guided endoscopic fundoplication using the Medigus Ultrasonic Surgical Endostapler (MUSESystem; MediGus, Ltd. Israel) in patients with esophageal or extra-esophageal gastro-oesophageal reflux disease (GERD)-related symptoms. The end of the study will be at the end of the 6-year follow-up of the last patient enrolled. The study proposes the following objectives:
- Primary objective: to evaluate the efficacy of endoscopic fundoplication with MUSE for the treatment of GERD, through clinical experience, in terms of:
- effect on GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaire scores
- effect on the use and dosage of proton pump inhibitors (PPI)
- feasibility and safety of the endoluminal fundoplication procedure
- Secondary objective: to characterize the treated patient population (demographic and objective data) and to identify the successful predictors of the procedure.
The study design includes the following phases:
*Preliminary patient evaluation and verification of inclusion criteria through: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- 6-month follow-up: Upper GI endoscopy Esophageal high-resolution manometry 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- 12-months follow-up: Upper GI endoscopy 24-hours esophageal pH-impedance OFF PPI PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
- Yearly clinical follow-up (up to 6 years):
PPI use GERD-HRQL and RSI questionnaires scores OFF PPI
Eligibility
Inclusion Criteria:
- Chronic (> 6 months) GERD-related esophageal or extra-esophageal symptoms
- Endoscopic or pH-impedance evidence of GERD (esophagitis, Barrett's esophagus, NERD, hypersensitive esophagus)
- Indication to surgical fundoplication
- Patients available for a long-term follow-up
Exclusion Criteria:
- Hiatal hernia ≥ 3 cm
- Major esophageal motility disorder
- Esophageal stenosis
- Malignant neoplasia (except minor superficial skin neoplasm)
- Portal hypertension, bleeding disorders so to controindicate surgery, esophageal varices, stenosis or diverticula
- Previous cardiac, thoracic or upper GI surgery
- BMI >40
- Pregnancy or breast feeding