Perceived quality of life after endoscopic vertical gastroplasty
Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty, a Descriptive Exploratory Study
This project tries to learn how adults in Italy feel about their quality of life at least six months after having endoscopic vertical gastroplasty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06839677 on ClinicalTrials.gov |
What this trial studies
This is a multicentre exploratory descriptive study led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS that uses a single semi-structured interview to capture patients' quality-of-life perceptions after endoscopic vertical gastroplasty (GVE). Eligible Italian adults must be at least six months post-GVE, able to give informed consent, and familiar with using a computer or tablet. Interviews are conducted remotely via Microsoft Teams, audio recorded, fully transcribed, and analyzed using NVivo v1.6.2 to identify themes and patterns in patient experiences.
Who should consider this trial
Good fit: Adults in Italy who are at least six months post-GVE, can understand and speak Italian, give informed consent, and have access to and basic competence with a computer or tablet are ideal candidates.
Not a fit: Patients less than six months after GVE, those without internet-enabled devices or Italian language proficiency, and those enrolled in other experimental GVE procedures are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could clarify how GVE affects day-to-day wellbeing and help clinicians counsel and support patients after the procedure.
How similar studies have performed: Previous studies of endoscopic gastroplasty have shown modest weight loss and mixed quality-of-life results, so the approach has some supporting data but its effect on long-term quality of life remains unclear.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: Patients older than 18 years. * Treatment: Patients who have undergone GVE surgery and have been in post- surgery for at least six months. * Access and technological competence: Patients who have a computer or tablet at home and are familiar with their use. * Informed consent: Patients who are able to understand and give informed consent informed consent to participate in the study. * Language comprehension: Patients who have a good understanding of the language Italian language, both written and spoken, to ensure correct completion and understanding of the informed consent and the study instructions. Exclusion Criteria: * Patients who have been enrolled in experimental studies involving additional procedures during GVE will be excluded
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario Agostino Gemelli — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Chiara Massari — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Chiara Massari
- Email: chiara.massari@policlinicogemelli.it
- Phone: +393926669423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.