跳至主要内容
临床试验/NCT06839677
NCT06839677招募中不适用

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
The perception of quality of life will be investigated through specific questions

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Semi-structured interview on quality of life (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Analysis of positive and negative experiences post-GVE(From treatment with GVE to ineterview. At least six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Massari Chiara

Research nurse

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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