Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty (SATIBAR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Semi-structured interview on quality of life

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiara Massari; Phone Number: +393926669423; Email: chiara.massari@policlinicogemelli.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli
      • Contact: Chiara Massari; Phone Number: +39 3926669423; Email: chiara.massari@policlinicogemelli.it
      • Principal Investigator: Chiara Massari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients who have undergone endoscopic vertical gastroplasty; Patients who have undergone endoscopic vertical gastroplasty and who are interviewed in a semi-structured interview regarding their quality of life 6 months after surgery.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The perception of quality of life will be investigated through specific questions	The perception of quality of life will be investigated through specific questions regarding: general well-being and satisfaction with different aspects of daily life, including personal satisfaction and perception of one's own body after the procedure, allowing participants to freely express their perceptions, concerns and wishes regarding their post-operative experience after GVE. Overall satisfaction with the GVE procedure.	From treatment with GVE to ineterview. At least six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of positive and negative experiences post-GVE	Analysis of positive and negative experiences with post-GVE to identify areas for improvement in the management of the patient undergoing GVE.	From treatment with GVE to ineterview. At least six months

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Chiara Massari, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): February 18, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: 7204 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No