PERCEPTION of QUALITY of LIFE in PATIENTS UNDERGOING ENDOSCOPIC VERTICAL GASTROPLASTY: a DESCRIPTIVE EXPLORATORY STUDY

NCT ID: NCT06839677

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-10-15

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.

Conditions

Endoscopy; Quality of Life of Patients; ENDOSCOPIC VERTICAL GASTROPLASTY; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

semi-structured interview on Microsoft Teams

Data will be collected through 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Massari Chiara

Research nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chiara Massari

Role: CONTACT

chiara.massari@policlinicogemelli.it

+393926669423

Other Identifiers

7204

Identifier Type: -

Identifier Source: org_study_id