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NCT Number: NCT06839677

Perception of Quality of Life in Patients Undergoing Endoscopic Vertical Gastroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00168, Italy

Location status: Recruiting

Location contact

Chiara Massari

CONTACT

[email protected]

+39 3926669423

Chiara Massari

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The perception of quality of life will be investigated through specific questions

    Time frame: From treatment with GVE to ineterview. At least six months

    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.

Secondary outcomes

  1. Analysis of positive and negative experiences post-GVE

    Time frame: From treatment with GVE to ineterview. At least six months

    Analysis of positive and negative experiences with post-GVE to identify areas for improvement in the management of the patient undergoing GVE.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Massari

CONTACT

[email protected]

+393926669423

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SATIBAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 21, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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