Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty

Official title

Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty, a Descriptive Exploratory Study

Overview

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.

Interventions

• Other Semi-structured interview on quality of life
  Data will be collected through a single semi-structured interview conducted by the principal investigators at each participating centre. A comprehensive review of the literature will be carried out to formulate the guiding questions for the interviews. The face-to-face interviews, conducted via the Microsoft Teams platform, will be flexible in order to prioritise patients' unique perspectives and explore all areas of research in depth.

Primary outcome measures

• The perception of quality of life will be investigated through specific questions [Time frame: From treatment with GVE to ineterview. At least six months]

Secondary outcome measures (1)

• Analysis of positive and negative experiences post-GVE [Time frame: From treatment with GVE to ineterview. At least six months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario Agostino Gemelli — Roma

Identifiers

NCT: NCT06839677 · 7204

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗