Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty

NCT06839677 | Recruiting

• 1 other identifier: 7204
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Analysis of positive and negative experiences post-GVE

  From treatment with GVE to ineterview. At least six months

Study Arms (1)

Patients who have undergone endoscopic vertical gastroplasty

EXPERIMENTAL

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

Interventions

Semi-structured interview on quality of life OTHER

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.

Patients who have undergone endoscopic vertical gastroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have been enrolled in experimental studies involving additional procedures during GVE will be excluded

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chiara Massari

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Massari

CONTACT

+393926669423; chiara.massari@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research nurse

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): February 18, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

IT (1)