Clinical trial NCT06839677: PERCEPTION of QUALITY of LIFE in PATIENTS UNDERGOING ENDOSCOPIC VERTICAL GASTROPLASTY: a DESCRIPTIVE EXPLORATORY STUDY
Official title: PERCEPTION of QUALITY of LIFE in PATIENTS UNDERGOING ENDOSCOPIC VERTICAL GASTROPLASTY: a DESCRIPTIVE EXPLORATORY STUDY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endoscopy
Quality of Life of Patients
ENDOSCOPIC VERTICAL GASTROPLASTY
Obesity
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective multi-centre exploratory descriptive observational study, survey.
Primary purpose: SUPPORTIVE_CARE

Brief summary: An emerging alternative to bariatric surgery for the treatment of obesity is bariatric endoscopic gastroplasty (gve), which offers a less invasive approach with fewer complications. however, the weight loss achieved through this technique is generally lower than that achieved with traditional bariatric surgery, leaving the impact on patients' quality of life uncertain. the aim of this multicentre exploratory descriptive study is to investigate the perception of the quality of life of patients with obesity undergoing gve, conducted at the complex operative unit of surgical digestive endoscopy of the university policlinico Agostino Gemelli IRCCS foundation as the promoting centre. italian patients over 18 years old, in post-gve follow-up for at least six months, with access to and familiarity with a computer or tablet will be included. data will be collected via a single semi-structured interview on microsoft teams, audio recorded and transcribed in full, and analysed using nvivo v1.6.2.32. participants' statements will be categorised into semantic categories and subsequently refined into sub-themes and themes through an iterative process.


Eligibility 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

Primary outcomes:
measure: The perception of quality of life will be investigated through specific questions
timeFrame: From treatment with GVE to ineterview. At least six months
Secondary outcomes:
measure: Analysis of positive and negative experiences post-GVE
timeFrame: From treatment with GVE to ineterview. At least six months
Other outcomes:
Locations:
Study officials:
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